⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Recalls in Puerto Rico

Official recalls distributed in Puerto Rico: 74 listing Puerto Rico by name, plus 4053 nationwide recalls. Vehicle (NHTSA) and consumer product (CPSC) recalls are not listed by state; see all recalls.

Distributed in Puerto Rico (74)

Bard Access Systems, Inc.: Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605150; Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605200;
Medical DevicesFDA (device) · 2026-09-23 · Class I
Bard Access Systems, Inc.: DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625150; DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625200; DuoGlide Short
Medical DevicesFDA (device) · 2026-09-23 · Class I
International Sprout Holdings, Inc: Alfalfa, Net Weight 50 lbs. bag, Product of USA, International Specialty Supply 1011 Volunteer Dr. Cookeville, TN 38506
FoodFDA (food) · 2026-09-16 · Class I
Dreyer's Grand Ice Cream Inc.: Outshine Fruit Bars Strawberry, 6-Count 2.5 ounce, with UPC 041548610047, packaged in paper outer cartons; individual fruit bars in plastic
FoodFDA (food) · 2026-09-02 · Class II
Dreyer's Grand Ice Cream Inc.: Outshine Fruit Bar Watermelon, 6-Count 2.5 ounce with UPC 041548413624, packaged in paper outer cartons; individual fruit bars in plastic wr
FoodFDA (food) · 2026-09-02 · Class II
Dreyer's Grand Ice Cream Inc.: Outshine Fruit Bars Grape, 6-Count 2.5 ounce, with UPC 041548244044, packaged in paper outer cartons; individual fruit bars in plastic wrapp
FoodFDA (food) · 2026-09-02 · Class II
Dreyer's Grand Ice Cream Inc.: Outshine Fruit Bars Tangerine, 6-Count 2.5 ounce, with UPC 041548612041, packaged in paper outer cartons; individual fruit bars in plastic w
FoodFDA (food) · 2026-09-02 · Class II
Dreyer's Grand Ice Cream Inc.: Outshine Fruit Bars Black Cherry, 6 Bars, 2.5 ounce, with UPC 041548000121, packaged in paper outer cartons; individual fruit bars in plasti
FoodFDA (food) · 2026-09-02 · Class II
Dreyer's Grand Ice Cream Inc.: Outshine Fruit Bars Strawberry, Pineapple, Grape, Tangerine. 24-Count 2.5 ounce, UPC 041548816678, packaged in paper outer cartons; individ
FoodFDA (food) · 2026-09-02 · Class II
Byron White Formulas, Inc.: Byron White FORMULAS A-L Complex Herbal Supplement 1.0 fl. oz./30 mL May Contain Nuts (Juglans nigra hull) Byron White Formulas Inc. 3315
FoodFDA (food) · 2026-09-02 · Class II
Byron White Formulas, Inc.: Byron White FORMULAS A-P Herbal Supplement 1.0 fl. oz./30 mL May Contain Nuts (Juglans nigra hull) Byron White Formulas Inc. 3315 Chanate
FoodFDA (food) · 2026-09-02 · Class II
Byron White Formulas, Inc.: Byron White FORMULAS A-FNG Herbal Supplement 1.0 fl. oz./30 mL May Contain Nuts (Juglans nigra hull) Byron White Formulas Inc. 3315 Chanat
FoodFDA (food) · 2026-09-02 · Class II
MARS SNACKING: MorningStar Farms Buffalo Chik'n Nuggets, 100% Plant Protein Vegan Nuggets, Net Wt. 10.5 oz. (298g), packaged in a resealable plastic bag wi
FoodFDA (food) · 2026-07-08 · Class II
MARS SNACKING: MorningStar Farms Hot & Spicy Sausage Patties, 100% Plant Protein Vegan Sausage Patties, Net Wt. 8 oz. (228g), packaged in a resealable plas
FoodFDA (food) · 2026-07-08 · Class II
CERELES EN GENERAL SAS: Pearl Milling Company Original Pancake & Waffle Mix Complete (Mezcla Para Panqueques y Waffles) Net Wt 5.99 oz (170 g). Packed in 50 - 5.99
FoodFDA (food) · 2026-07-01 · Class I
Refresqueria Estrella Inc.: ESTRELLA, Bebida de Parcha (Passion Fruit Drink), multiple sizes, 14 OZ.FL. (413 ML), 64 OZ.FL (1,920mL), 120 OZ.FL. (3.54LT.) 14 OZ.FL Pla
FoodFDA (food) · 2026-06-17 · Class III
Intuitive Surgical, Inc.: Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Prefa
Medical DevicesFDA (device) · 2026-06-10 · Class II
Llorens Pharmaceuticals International Division, Inc.: Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement, Net Wt. 8 FL Oz (237mL) Amber PET modern round 24-400 bottle, 47 SERVING PER B
FoodFDA (food) · 2026-05-27 · Class II
Costco Wholesale Corporation: Kirkland Signature Traditional Madeleines 12 Count/net wt. 18oz., Item #2000012, UPC 000020000127. Plastic clamshell container is packed wit
FoodFDA (food) · 2026-04-29 · Class I
Teva Pharmaceuticals USA, Inc: Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 070
DrugsFDA (drug) · 2026-04-15 · Class II
Teva Pharmaceuticals USA, Inc: Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 070
DrugsFDA (drug) · 2026-04-15 · Class II
Ultradent Products, Inc.: Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.
Medical DevicesFDA (device) · 2026-04-08 · Class II
Winder Laboratories, LLC: Multivitamin with Fluoride Chewable Tablets Grape Flavor Rx NDC 75826-169-10 0.25 mg 100 TABLETS UPC 3 15826 16910 2; NDC 75826-171-10 1mg 1
FoodFDA (food) · 2026-03-25 · Class III
Exactech, Inc.: Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
Medical DevicesFDA (device) · 2026-03-18 · Class II
Exactech, Inc.: Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X
Medical DevicesFDA (device) · 2026-03-18 · Class II
Encore Medical, LP: EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
Medical DevicesFDA (device) · 2026-02-11 · Class II
Encore Medical, LP: EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hooded, HXe+, 36J, REF: 942-01-36J; Liner,
Medical DevicesFDA (device) · 2026-02-11 · Class II
Beckman Coulter Ireland, Inc.: The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from non-LDL- lipopro
Medical DevicesFDA (device) · 2026-01-28 · Class II
Advanced Pharmaceutical Technology, Inc.: TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical Technology, 132 South
DrugsFDA (drug) · 2026-01-21 · Class II
Town Food Service Equip Co Inc: Town Food Service EQ CO Inc. brand Aluminum Sauce Pans in 1QT, 1.5QT, 2 QT, and 3QT sizes; UPC Codes: 843784003559, 843784003566, 8437840035
FoodFDA (food) · 2026-01-14 · Class II
Rovira Biscuit Corporation: Snack Crackers 100to en boca (ciento en boca) Rovira, Net Wt. 1.5 oz, 12 pack Snack Crackers to go, 12 packets (Net Wt 1.5 oz bag) per box,
FoodFDA (food) · 2026-01-14 · Class II
Rovira Biscuit Corporation: Tempting Crackers Tray, Rovira, 3 foil wrap trays per Net Wt. 8oz box (Net Wt 5 oz trays), 6 box per case. UPC 072981003127 Tempting Cracke
FoodFDA (food) · 2026-01-14 · Class II
Rovira Biscuit Corporation: Vanilla Econo, Galletas de Vainilla, 8 paquets per Net Wt. 9.6 oz box (272 g), 6 box per case. UPC 072981005022
FoodFDA (food) · 2026-01-14 · Class II
Rovira Biscuit Corporation: Vanilla Treats Crackers, Rovira, Net Wt. 31 oz (878.83 g) cans, 6/31oz cans per case. Mini Vanilla Treats, Rovira, 12 to go packs (0.8oz (2
FoodFDA (food) · 2026-01-14 · Class II
Rovira Biscuit Corporation: Vainilla Crackers, Great Value (Galletas Vainilla)8 Foil Packets (17 g each), Net Wt.9.6 oz (272 g) box, 6 boxes per case. UPC 072981005022
FoodFDA (food) · 2026-01-14 · Class II
Rovira Biscuit Corporation: Tita Crackers Rovira, 3 (1/2 oz (15g) Foil Fresh Packets Net Wt.8 oz (226.8 g) boxes, 6/8oz boxes per case. UPC 072981005121 Tita Crackers
FoodFDA (food) · 2026-01-14 · Class II
DICOM Grid, Inc.: Intelerad InteleShare software, with ProViewer component
Medical DevicesFDA (device) · 2025-12-24 · Class II
DSAART LLC: Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant Model/Catalog Numbers: 600-601 - Silicone Carving Implant S
Medical DevicesFDA (device) · 2025-12-24 · Class II
DSAART LLC: Brand Name: AART Gluteal Implant Product Name: Gluteal Implant Model/Catalog Numbers: 501-101 - Gluteal Implant style 1 size 1 UDI-DI co
Medical DevicesFDA (device) · 2025-12-24 · Class II
DSAART LLC: Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numbers: 400-0101 Chin Implant style 1 size 1 UDI-DI code: B49040
Medical DevicesFDA (device) · 2025-12-24 · Class II
DSAART LLC: Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number: 401-202-5 Malar Implant style 2 size 2 left UDI-DI code
Medical DevicesFDA (device) · 2025-12-24 · Class II
DSAART LLC: Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalog Number: 500-106-5 Pectoral Implant style 1 size 6 left UD
Medical DevicesFDA (device) · 2025-12-24 · Class II
DSAART LLC: Brand Name: AART Calf Implant Product Name: Calf Implant Model/Catalog Number: 502-103 - Calf Implant style 1 size 3 UDI-DI code: B49050
Medical DevicesFDA (device) · 2025-12-24 · Class II
CELEBRATION HERBALS US: Celebration Herbals Senna Leaf Herbal Tea 24 Teabags, net wt. 1.48oz. UPC 628240201829
FoodFDA (food) · 2025-12-24 · Class II
Great Lakes Cheese Co Inc: Low-moisture part-skim mozzarella shredded cheese, individually packaged in a plastic bag, as: 1) Always Save - Shredded, 5 lb., UPC 700386
FoodFDA (food) · 2025-12-10 · Class II
Great Lakes Cheese Co Inc: Happy Farms by Aldi Italian Style shredded cheese blend (containing low-moisture part-skim mozzarella, not-smoked provolone, romano, asiago
FoodFDA (food) · 2025-12-10 · Class II
Great Lakes Cheese Co Inc: Italian style shredded cheese blend (containing low-moisture part-skim mozzarella, provolone, parmesan, romano, fontina and asiago cheese),
FoodFDA (food) · 2025-12-10 · Class II
Great Lakes Cheese Co Inc: Food Club Finely Shredded Pizza Style Four Cheese Blend (containing low-moisture part-skim mozzarella, not-smoked provolone, parmesan & roma
FoodFDA (food) · 2025-12-10 · Class II
Great Lakes Cheese Co Inc: Pizza style shredded cheese blend (containing low-moisture part-skim mozzarella and mild cheddar cheeses), individually packaged in a plasti
FoodFDA (food) · 2025-12-10 · Class II
Great Lakes Cheese Co Inc: Mozzarella and provolone shredded cheese blend (containing low-moisture part-skim mozzarella and not-smoked provolone cheeses), individually
FoodFDA (food) · 2025-12-10 · Class II
Great Lakes Cheese Co Inc: Good & Gather Mozzarella & Parmesan shredded cheese blend, Fine Cut, 8 oz., individually packaged in a plastic bag, UPC 8523903856, 12/case
FoodFDA (food) · 2025-12-10 · Class II
Costco Wholesale Corporation: Costco Item# 19927 Kirkland Signature Caesar Salad, refrigerated, packaged in clear plastic clamshell container. The net weight varies as it
FoodFDA (food) · 2025-12-10 · Class II
Costco Wholesale Corporation: Costco Item# 11444 Kirkland Signature Chicken Sandwich with Caesar Salad, refrigerated, packaged in clear plastic clamshell container. The n
FoodFDA (food) · 2025-12-10 · Class II
CA BOTANA International, Inc.: Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g per tube, Manufactured by CA Botana, San Diego, CA 92123. NDC:
DrugsFDA (drug) · 2025-12-03 · Class II
CA BOTANA International, Inc.: Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50, Zinc Oxide 21%, 2.1 oz/61 g per tube, Manufactured by CA BOTANA, San Diego,
DrugsFDA (drug) · 2025-12-03 · Class II
CA BOTANA International, Inc.: Doctor D. Schwab Controlling Balm with Tea Tree Oil, Salicyclic Acid 0.8%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA BOTAN
DrugsFDA (drug) · 2025-12-03 · Class II
CA BOTANA International, Inc.: Doctor D. Schwab Controlling Cream, Benzoyl Peroxide 2.7%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA
DrugsFDA (drug) · 2025-12-03 · Class II
CA BOTANA International, Inc.: Sea Enzyme Ultra Umbrella Sunscreen SPF 30, Titanium Dioxide 4%, Octinoxate 4%, 4 oz./113.4 g per tube, Manufactured by CA BOTANA, San Dieg
DrugsFDA (drug) · 2025-12-03 · Class II
CA BOTANA International, Inc.: Doctor D. Schwab Clinical Weh Weh Natural Pain Relief Gel with Menthol and Arnica, Menthol 5%, 4.2 oz./120 g per tube, Doctor D. Schwab, A d
DrugsFDA (drug) · 2025-12-03 · Class II
CA BOTANA International, Inc.: Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30, Titanium Dioxide 5% and Octinoxate 4%, 4 oz./113.4 g per tube, Doctor D. Schwab, A di
DrugsFDA (drug) · 2025-12-03 · Class II
CA BOTANA International, Inc.: Gabriel Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz, Net 61 g per tube, Dist. By: Gabriel Cosmetics, Inc., Redmond, WA USA 98052, NDC:
DrugsFDA (drug) · 2025-12-03 · Class II
CA BOTANA International, Inc.: Karina Daily Moisturizer SPF 25, Octinoxate 7.5% and Zinc Oxide 7.0%, Net WT. 5 oz/ 141.7 g per tube, Dist. By: Beauty4Pros LLC, Palm Desert
DrugsFDA (drug) · 2025-12-03 · Class II
CA BOTANA International, Inc.: Sugared+Bronzed Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, Net WT 3.3 OZ (93 G) per tube, Dist. By: Sugared+Bronzed, 929 Montana Ave,
DrugsFDA (drug) · 2025-12-03 · Class II
CA BOTANA International, Inc.: Elixir by Coco March Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 0
DrugsFDA (drug) · 2025-12-03 · Class II
CA BOTANA International, Inc.: Elixir by Coco March Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Jua
DrugsFDA (drug) · 2025-12-03 · Class II
CA BOTANA International, Inc.: CLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle, Distributed by: CLEARSTEM Skincare, clearstemskincare.com. NDC: 3
DrugsFDA (drug) · 2025-12-03 · Class II
CA BOTANA International, Inc.: Dr. Bump Natural Pain Relief Gel, Menthol 5%, NET WT 4 FL OZ/118 ML per bottle, Distr. by 1Beauty US LLC, Palm Desert, CA 92211. NDC: 35192
DrugsFDA (drug) · 2025-12-03 · Class II
Merit Medical Systems, Inc.: PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/
Medical DevicesFDA (device) · 2025-11-26 · Class II
Plenus Group Inc.: Rockport Lobser Bisque; packed in 2x8lb pouches and in 4x4b pouches
FoodFDA (food) · 2025-11-26 · Class I
Tandem Diabetes Care, Inc.: Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus del
Medical DevicesFDA (device) · 2025-11-12 · Class I
PHILIPS MEDICAL SYSTEMS: Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X;
Medical DevicesFDA (device) · 2025-11-05 · Class II
PHILIPS MEDICAL SYSTEMS: Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;
Medical DevicesFDA (device) · 2025-11-05 · Class II
PHILIPS MEDICAL SYSTEMS: Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.X;
Medical DevicesFDA (device) · 2025-11-05 · Class II
Sprout Organics Inc.: 6+ Months SPROUT ORGANICS Made With Organic Sweet Potato, Apple & Spinach NET WT. 3.5 OZ (99g) INGREDIENTS: ORGANIC SWEET POTATOES, ORGANIC
FoodFDA (food) · 2025-10-22 · Class II

Nationwide (4053)

ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-LINE (CS 18) WHITE Model/Catalog Number: 553322 Software Ver
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-LINE (CS 18) WHITE Model/Catalog Number: 553323 Software Ver
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 8" X 2.5" 2-LINE (CS 10) Model/Catalog Number: 564001 Software Version:
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 2-LINE (CS 10) PLUM Model/Catalog Number: 564003 Software Ve
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 15" X 4" 2-LINE (CS 10) GRAY Model/Catalog Number: 564005 Software Vers
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 18" X 4" 1-LINE (CS 10) RED Model/Catalog Number: 564006 Software Versi
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 18" X 4" 2-LINE (CS 10) RED Model/Catalog Number: 564007 Software Versi
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 24" X 4" 1-LINE (CS 10) YELLOW Model/Catalog Number: 564008 Software Ve
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 24" X 4" 2-LINE (CS 10) YELLOW Model/Catalog Number: 564009 Software Ve
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-LINE (CS 10) WHITE Model/Catalog Number: 564010 Software Ver
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-LINE (CS 10) WHITE Model/Catalog Number: 564011 Software Ver
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 34" X 4" 1-LINE (CS 10) BLUE Model/Catalog Number: 564012 Software Vers
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 34" X 4" 2-LINE (CS 10) BLUE Model/Catalog Number: 564013 Software Vers
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 44" X 4" 1-LINE (CS 10) GREEN Model/Catalog Number: 564014 Software Ver
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 44" X 4" 2-LINE (CS 10) GREEN Model/Catalog Number: 564015 Software Ver
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 20" X 6" 1-LINE (CS 10) NAVY BLUE Model/Catalog Number: 564017 Software
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 26" X 6" 1-LINE (CS 10) ORANGE Model/Catalog Number: 564019 Software Ve
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 38" X 4" 1-LINE (CS 10) Model/Catalog Number: 564044 Software Version:
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 8" X 2.5" 1-LINE (CS 12) LIGHT BLUE Model/Catalog Number: A70107000 Sof
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 8" X 2.5" 2-LINE (CS 12) LIGHT BLUE Model/Catalog Number: A70107001 Sof
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 1-LINE (CS 12) PLUM Model/Catalog Number: A70107002 Software
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 2-LINE (CS 12) PLUM Model/Catalog Number: A70107003 Software
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 15" X 4" 1-LINE (CS 12) GRAY Model/Catalog Number: A70107004 Software V
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 15" X 4" 2-LINE (CS 12) GRAY Model/Catalog Number: A70107005 Software Ve
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 1-LINE (CS 18) RED Model/Catalog Number: A70107006 Software Ver
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 2-LINE (CS 18) RED Model/Catalog Number: A70107007 Software Ver
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 24" X 4" 1-LINE (CS 18) YELLOW Model/Catalog Number: A70107008 Software
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 24" X 4" 2-LINE (CS 18) YELLOW Model/Catalog Number: A70107009 Software
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 1-LINE (CS 18) BLUE Model/Catalog Number: A70107010 Software Ve
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 2-LINE (CS 18) BLUE Model/Catalog Number: A70107011 Software Ve
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 1-LINE (CS 12) GREEN Model/Catalog Number: A70107012 Software V
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 2-LINE (CS 12) GREEN Model/Catalog Number: A70107013 Software V
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name:DISPOSABLE BB TOURNQUET CUFF, 20" X 6" DUAL BLADDER 1-LINE (CS 12) NAVY BLUE Model/Catalog Number: A7
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name:DISPOSABLE BB TOURNQUET CUFF, 26" X 6" DUAL BLADDER, 1-LINE (CS 12) ORANGE Model/Catalog Number: A701
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name:DISPOSABLE BB TOURNQUET CUFF, 26" X 6" DUAL BLADDER, 2-LINE (CS 12) ORANGE Model/Catalog Number: A7
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 2-Line, Plum Model/Catalog Number: ASP-564003 Software Version
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 1-Line, Red Model/Catalog Number: ASP-564006 Software Version: N
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 2-Line, Red Model/Catalog Number: ASP-564007 Software Version: N
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 24" X 4" 1-Line, Yellow Model/Catalog Number: ASP-564008 Software Version
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 24" X 4" 2-Line, Yellow Model/Catalog Number: ASP-564009 Software Version
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-Line, White Model/Catalog Number: ASP-564010 Software Version:
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-Line, White Model/Catalog Number: ASP-564011 Software Version:
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 1-Line, Blue Model/Catalog Number: ASP-564012 Software Version
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 2-Line, Blue Model/Catalog Number: ASP-564013 Software Version:
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 1-Line, Green Model/Catalog Number: ASP-564014 Software Version:
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 2-Line, Green Model/Catalog Number: ASP-564015 Software Versio
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: MPR Product Name:DISPOSABLE TOURNIQUET CUFF 20" DUAL BLADDER, 1 LINE (10) Model/Catalog Number: DB-7018-01Q Software Version:
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: MPR Product Name:DISPOSABLE TOURNIQUET CUFF 20" DUAL BLADDER, 2 LINE (10) Model/Catalog Number: DB-7020-02Q Software Version:
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 26" DUAL BLADDER, 2 LINE (10) Model/Catalog Number: DB-7024-02Q Software Version:
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 18" 1 LINE (10) Model/Catalog Number: DT-7018-01Q Software Version: Not Applicabl
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 24" 1 LINE (10) Model/Catalog Number: DT-7024-01Q Software Version: Not Applicabl
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 24" 2 LINE (10) Model/Catalog Number: DT-7024-02Q Software Version: Not Applicabl
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 30" 1 LINE (10) Model/Catalog Number: DT-7030-01Q Software Version: Not Applicabl
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 30" 2 LINE (10) Model/Catalog Number: DT-7030-02Q Software Version: Not Applicabl
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 34" 1 LINE (10) Model/Catalog Number: DT-7034-01Q Software Version: Not Applicabl
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 34" 2 LINE (10) Model/Catalog Number: DT-7034-02Q Software Version: Not Applicabl
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 44" 1 LINE (10) Model/Catalog Number: DT-7044-01Q Software Version: Not Applicabl
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 44" 2 LINE (10) Model/Catalog Number: DT-7044-02Q Software Version: Not Applicabl
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 8" 2 LINE (10) Model/Catalog Number: DT-7108-02Q Software Version: Not Applicable
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 12" 1 LINE (10) Model/Catalog Number: DT-7112-01Q Software Version: Not Applicabl
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 12" 2 LINE (10) Model/Catalog Number: DT-7112-02Q Software Version: Not Applicabl
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 15" 1 LINE (10) Model/Catalog Number: DT-7115-01Q Software Version: Not Applicabl
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 15" 2 LINE (10) Model/Catalog Number: DT-7115-02Q Software Version: Not Applica
Medical DevicesFDA (device) · 2026-10-07 · Class II
ASP Global, LLC.: Brand Name: MPR Product Name:DISPOSABLE TOURNIQUET CUFF 18" 2 LINE (10) Model/Catalog Number: DT-7218-02Q Software Version: Not Applica
Medical DevicesFDA (device) · 2026-10-07 · Class II
Custom Interventional Pain Management, LLC: Brand Name: Ferndale Laboratories; Medline; Custom Interventional Pain Management CIPM Product Name: Mastisol Skin Adhesive Model/Catalog
Medical DevicesFDA (device) · 2026-10-07 · Class II
Illumina, Inc.: NovaSeq 6000Dx including DRAGEN Server, Catalog Number: 20068232; Illumina DRAGEN Server for NextSeq 550Dx, Catalog Number: 20086130
Medical DevicesFDA (device) · 2026-10-07 · Class II
Medline Industries, LP: Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories, Hand Pendants: MDR510094 PENDANT F/ MDR107002E MDR520094 PENDANT
Medical DevicesFDA (device) · 2026-10-07 · Class I
Medline Industries, LP: Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR107000P BED, MANUAL, MEDLITE
Medical DevicesFDA (device) · 2026-10-07 · Class I
Draeger, Inc.: VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathing circuit for use with a resuscitation module.
Medical DevicesFDA (device) · 2026-10-07 · Class I
HeartSine Technologies Ltd: HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016
Medical DevicesFDA (device) · 2026-10-07 · Class III
Alere San Diego, Inc.: McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001; Alere hCG Cassette (20 mIU/mL) in Urine, Model/ Part: FHC-A102/92210; Fis
Medical DevicesFDA (device) · 2026-10-07 · Class II
Alere San Diego, Inc.: Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528; Beckman Coulter Inc's ICON 25 hCG, Model/ Pa
Medical DevicesFDA (device) · 2026-10-07 · Class II
Alere San Diego, Inc.: Fisher Scientific Sure-Vue Urine hCG Strip, Model/ Part: FHC-101/23900527; McKesson CONSULT hCG Urine Test Dipstick CLIA Waived, Model/ Par
Medical DevicesFDA (device) · 2026-10-07 · Class II
Alere San Diego, Inc.: Fisher Scientific Sure-Vue Urine hCG, Model/ Part: FHC-102/23900526; Henry Schein, Inc. One Step + Urine Cassette Test, Model/ Part: FHC-10
Medical DevicesFDA (device) · 2026-10-07 · Class II
Bard Peripheral Vascular Inc: EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with softw
Medical DevicesFDA (device) · 2026-10-07 · Class II
Volcano Corp: Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
Medical DevicesFDA (device) · 2026-10-07 · Class II
Shanghai United Imaging Healthcare Co., Ltd.: Computed Tomography X-ray System, Model: uCT 530 with software
Medical DevicesFDA (device) · 2026-10-07 · Class II
Shanghai United Imaging Healthcare Co., Ltd.: Computed Tomography X-ray System, Model: uCT 550 with software
Medical DevicesFDA (device) · 2026-10-07 · Class II
Shanghai United Imaging Healthcare Co., Ltd.: Computed Tomography X-ray System, Model: uCT 760 with software
Medical DevicesFDA (device) · 2026-10-07 · Class II
Shanghai United Imaging Healthcare Co., Ltd.: Computed Tomography X-ray System, Model: uCT 780 with software
Medical DevicesFDA (device) · 2026-10-07 · Class II
Shanghai United Imaging Healthcare Co., Ltd.: Computed Tomography X-ray System, Model: uCT ATLAS with software
Medical DevicesFDA (device) · 2026-10-07 · Class II
Shanghai United Imaging Healthcare Co., Ltd.: Computed Tomography X-ray System, Model: uCT ATLAS Astound with software
Medical DevicesFDA (device) · 2026-10-07 · Class II
Shanghai United Imaging Healthcare Co., Ltd.: Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with software
Medical DevicesFDA (device) · 2026-10-07 · Class II
Shanghai United Imaging Healthcare Co., Ltd.: Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with software
Medical DevicesFDA (device) · 2026-10-07 · Class II
Shanghai United Imaging Healthcare Co., Ltd.: Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama GS with software
Medical DevicesFDA (device) · 2026-10-07 · Class II
Shanghai United Imaging Healthcare Co., Ltd.: Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo with software
Medical DevicesFDA (device) · 2026-10-07 · Class II
Shanghai United Imaging Healthcare Co., Ltd.: Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S with software
Medical DevicesFDA (device) · 2026-10-07 · Class II
Shanghai United Imaging Healthcare Co., Ltd.: Positron Emission Tomography and Computed Tomography System, Model: uMI 780
Medical DevicesFDA (device) · 2026-10-07 · Class II
American Nitrile Operations Llc: Brand Name: Performance Pro Product Name: Performance Pro Model/Catalog Number: 72-RM50601,72-RM50602, 72-RM50603,72-RM50604 Product Desc
Medical DevicesFDA (device) · 2026-10-07 · Class II
American Nitrile Operations Llc: Brand Name: Opportunity Flex Product Name: Opportunity Flex Model/Catalog Number: 72-50900, 72-50901, 72-50902, 72-50903, 72-50904 Produc
Medical DevicesFDA (device) · 2026-10-07 · Class II
American Nitrile Operations Llc: Brand Name: Opportunity Pro Product Name: Opportunity Pro Model/Catalog Number: 72-50800, 72-50801,72-50802,72-50803,72-50804 Product Des
Medical DevicesFDA (device) · 2026-10-07 · Class II
American Contract Systems Inc: Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ROBOTIC PACK - 242561 Model No. MHRB88
Medical DevicesFDA (device) · 2026-10-07 · Class II
American Contract Systems Inc: Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays CARDIAC HEART BUNDLE NS Model No. LM
Medical DevicesFDA (device) · 2026-10-07 · Class II
American Contract Systems Inc: Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ABDOMINAL HYSTERECTOMY - 205989 Mode
Medical DevicesFDA (device) · 2026-10-07 · Class II
Cardinal Health 200, LLC: Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAP CHOLE , Catalog Number: PGCGLCBAC; 2) KIT
Medical DevicesFDA (device) · 2026-10-07 · Class II
Cardinal Health 200, LLC: Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT,GU DAVINCI , Catalog Number: PGVMDVBWU; 2) KIT
Medical DevicesFDA (device) · 2026-10-07 · Class II
Cardinal Health 200, LLC: Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLAC; 2) KI
Medical DevicesFDA (device) · 2026-10-07 · Class II
Cardinal Health 200, LLC: Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAVH , Catalog Number: PB63VHSTC
Medical DevicesFDA (device) · 2026-10-07 · Class II
Heraeus Medical GmbH (Dental Division): PALACOS R pro 40; PALACOS R pro 80. Model/Catalog Numbers: 5081286; 5081287. Radiopaque, poly (methyl methacrylate)-based (PMMA) bone cem
Medical DevicesFDA (device) · 2026-10-07 · Class II
Heraeus Medical GmbH (Dental Division): PALACOS R+G pro 40; PALACOS R+G pro 80. Model/Catalog Number: 5081288; 5081289. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone
Medical DevicesFDA (device) · 2026-10-07 · Class II

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