Medline Industries, LP: Medline Convenience Kits: 1) DYNDA3003, Model Number: DENTAL PACK; 2) DYNJ87157, Model Number: GULLO SURGICAL PACK

Company / brand

Medline Industries, LP

Product

Medline Convenience Kits: 1) DYNDA3003, Model Number: DENTAL PACK; 2) DYNJ87157, Model Number: GULLO SURGICAL PACK

Reason / hazard

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Classification

Class II

Status

Ongoing

Distribution / sold at

Worldwide - US Nationwide distribution.

Recall initiated

2026-01-07

Code info

1) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 22JBH446; 2) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23ABA768; 3) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23BBS986; 4) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23CBN951; 5) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23CBT510; 6) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23CBV199; 7) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23GBA134; 8) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23JBH393; 9) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 24BBH600; 10) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 24CMF059; 11) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 24CMF059A; 12) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 24EMC989; 13) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 24HME376; 14) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 24JMG165; 15) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 24KMH629; 16) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 25AMD692; 17) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 25EMB013; 18) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 25FMI462; 19) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 25HMH340; 20) DYNJ87157, UDI-DI: 10198459014482(each), 40198459014483(case), Lot Number: 24ILA361

Product quantity

3508 units

Voluntary mandated

Voluntary: Firm initiated

City

Northfield

State

IL

Country

United States

Event id

98642

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