Device recall
Medline Convenience Kits: 1) PRE-OP KIT, Catalog Number: DYKS1043F; 2) PRE OP KIT, Catalog Number: DYKS1128C; 3) PRE OP KIT, Catalog Number: DYKS1216I; 4) PRE OP KIT, Catalog Number: DYKS1325A; 5) CATARACT PREOP KIT, Catalog Number: DYKS1583; 6) GENERAL PREOP KIT, Catalog Number: DYKS1584; 7) GENERAL PREOP KIT, Catalog Number: DYKS1584A; 8) GENERAL PREOP KIT, Catalog Number: DYKS1584B
- Recall number
- Z-3058-2026
- Event id
- 99334
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Medline Industries, LP
- Report date
- Sep 9, 2026
- Posted
- Aug 31, 2026
- Initiated
- Jun 12, 2026
- Center classification date
- Aug 31, 2026
- Product code
- OJU
- Device type
- Skin Prep Tray
- Reason
- The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.
- Root cause
- Nonconforming Material/Component
- Quantity
- 13032 kits
- Code info
- 1) DYKS1043F, UDI-DI: 10195327392086(each), 40195327392087(case), Lot Number: 23KBL520; 2) DYKS1043F, UDI-DI: 10195327392086(each), 40195327392087(case), Lot Number: 23LBP488; 3) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 25ABQ496; 4) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 24CBI654; 5) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 24DBU596; 6) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 24FBA388; 7) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 24GBD436; 8) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 24JBC974; 9) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 24KBA645; 10) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 23LBB037; 11) DYKS1216I, UDI-DI: 10198459362668(each), 40198459362669(case), Lot Number: 25GBP888; 12) DYKS1325A, UDI-DI: 10195327549343(each), 40195327549344(case), Lot Number: 25ABT088; 13) DYKS1325A, UDI-DI: 10195327549343(each), 40195327549344(case), Lot Number: 24KBO407; 14) DYKS1325A, UDI-DI: 10195327549343(each), 40195327549344(case), Lot Number: 24ABO808; 15) DYKS1325A, UDI-DI: 10195327549343(each), 40195327549344(case), Lot Number: 24CBI736; 16) DYKS1325A, UDI-DI: 10195327549343(each), 40195327549344(case), Lot Number: 24EBN336; 17) DYKS1325A, UDI-DI: 10195327549343(each), 40195327549344(case), Lot Number: 24IBP255; 18) DYKS1583, UDI-DI: 10198459027666(each), 40198459027667(case), Lot Number: 24GBW364; 19) DYKS1584, UDI-DI: 10198459027659(each), 40198459027650(case), Lot Number: 24GBW365; 20) DYKS1584A, UDI-DI: 10198459146633(each), 40198459146634(case), Lot Number: 24JBA740; 21) DYKS1584B, UDI-DI: 10198459292750(each), 40198459292751(case), Lot Number: 25EBD220
- Distribution
- US Nationwide distribution.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Northfield, IL, United States