Z-3050-2026 Class II Ongoing
FDA device recall Z-3050-2026 was initiated by Medline Industries, LP on June 12, 2026 and is designated Class II. Reason for recall: 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… The recall status is ongoing. Affected quantity: 58037 kits.
Recall Details
- Product Type
- Devices
- Report Date
- September 9, 2026
- Initiation Date
- June 12, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 58037 kits
Product Description
Medline Convenience Kits: 1) DYKM1414, Catalog Number: DYKM1414; 2) DYKM1414, Catalog Number: DYKM1414; 3) DYNDH1462A, Catalog Number: DYNDH1462A; 4) DYNJ38145F, Catalog Number: DYNJ38145F; 5) DYNJ63199A, Catalog Number: DYNJ63199A
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution.
Code Information
1) DYKM1414, UDI-DI: 10889942481293(each), 40889942481294(case), Lot Number: 25BBB327; 2) DYKM1414, UDI-DI: 10889942481293(each), 40889942481294(case), Lot Number: 24KBE261; 3) DYNDH1462A, UDI-DI: 10193489993424(each), 40193489993425(case), Lot Number: 24ABC301; 4) DYNDH1462A, UDI-DI: 10193489993424(each), 40193489993425(case), Lot Number: 24ABT704; 5) DYNDH1462A, UDI-DI: 10193489993424(each), 40193489993425(case), Lot Number: 24BBO246; 6) DYNDH1462A, UDI-DI: 10193489993424(each), 40193489993425(case), Lot Number: 24BBU663; 7) DYNDH1462A, UDI-DI: 10193489993424(each), 40193489993425(case), Lot Number: 24CBJ141; 8) DYNDH1462A, UDI-DI: 10193489993424(each), 40193489993425(case), Lot Number: 23JBH263; 9) DYNDH1462A, UDI-DI: 10193489993424(each), 40193489993425(case), Lot Number: 23JBO539; 10) DYNDH1462A, UDI-DI: 10193489993424(each), 40193489993425(case), Lot Number: 23KBG333; 11) DYNDH1462A, UDI-DI: 10193489993424(each), 40193489993425(case), Lot Number: 23KBV434; 12) DYNDH1462A, UDI-DI: 10193489993424(each), 40193489993425(case), Lot Number: 23LBM123; 13) DYNJ38145F, UDI-DI: 10193489277173(each), 40193489277174(case), Lot Number: 25ABS139; 14) DYNJ38145F, UDI-DI: 10193489277173(each), 40193489277174(case), Lot Number: 24EBP237; 15) DYNJ38145F, UDI-DI: 10193489277173(each), 40193489277174(case), Lot Number: 24KBE336; 16) DYNJ38145F, UDI-DI: 10193489277173(each), 40193489277174(case), Lot Number: 23JBM582; 17) DYNJ38145F, UDI-DI: 10193489277173(each), 40193489277174(case), Lot Number: 23LBM892; 18) DYNJ63199A, UDI-DI: 10193489311730(each), 40193489311731(case), Lot Number: 24EBG970