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OBP Medical Corporation: OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1

Medical DevicesSource: FDA (device) · Date: 2026-08-19

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
OBP Medical Corporation
Product
OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1
Reason / hazard
There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions for both the patient and the healthcare provider.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV and the countries of HKG, CAN, NOR, UAE.
Recall initiated
2026-07-13
Code info
UDI: (01)20888937027451/ Lots: 24J1202Z, 25D2302Z, 25A0202Z, 25E1502Z, 25B2802Z, 25L0802Z
Product quantity
8,224 boxes (148,032 units)
Voluntary mandated
Voluntary: Firm initiated
City
Lawrence
State
MA
Country
United States
Event id
99433
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