FDAClass II · Medical device · Recalled May 13, 2026
Medline Convenience Kits recall — Medline Industries, LP
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.
Class II: may cause temporary or medically reversible health consequences.
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- Z-2100-2026
- Brand
- Medline Industries
- Classification
- Class II
- Units affected
- 826 units
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Number: DYNJ83185A; 3) LAP BASIN, Model Number: DYNJVB91109D
Affected products
Companies & origin
- Recalling firm location
- Northfield, IL, United States
- Firm address
- 3 Lakes Dr, 60093-2753
Identifying details (verbatim from the notice)
- Product codes / lots
- 1) DYNJ83185, UDI-DI: 10195327247058(each), 40195327247059(case), Lot Number: 22LDA486; 2) DYNJ83185, UDI-DI: 10195327247058(each), 40195327247059(case), Lot Number: 23CDA474; 3) DYNJ83185, UDI-DI: 10195327247058(each), 40195327247059(case), Lot Number: 23CDB552; 4) DYNJ83185, UDI-DI: 10195327247058(each), 40195327247059(case), Lot Number: 23FDC392; 5) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 23HDB637; 6) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24CDA984; 7) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24CDB327; 8) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24CDB829; 9) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24DDB769; 10) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24EDB468; 11) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24FDB302; 12) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24GDB922; 13) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24IDB525; 14) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24KDB955; 15) DYNJVB91109D, UDI-DI: 10198459514838(each), 40198459514839(case), Lot Number: 25LLA489
- Distribution
- Worldwide - US Nationwide distribution.
- Firm notified the public via
- Letter
- FDA event ID
- 98642
- Recall initiated
- January 7, 2026
- FDA classified
- May 7, 2026
- FDA report date
- May 13, 2026
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim;
the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.
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