Reported Sep 9, 2026 · Ongoing · Updated Sep 14, 2026
Medline Convenience Kits
Medline Industries, LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medline Industries, LP · 3 Lakes Dr · Northfield, IL · 60093-2753
Is this the product you have?
Medline Convenience Kits
8 of 8 products
| Model / number | Product as published |
|---|---|
DYKS1043F | PRE-OP KIT |
DYKS1128C | PRE OP KIT |
DYKS1216I | PRE OP KIT |
DYKS1325A | PRE OP KIT |
DYKS1583 | CATARACT PREOP KIT |
DYKS1584 | GENERAL PREOP KIT |
DYKS1584A | GENERAL PREOP KIT |
DYKS1584B | GENERAL PREOP KIT |
- Lot codes and dates
21 of 21 products
Products covered by this recall # Barcodes Product as published 1 1019532739208640195327392087Lot Number: 23KBL520; 2) DYKS1043F, UDI-DI: 10195327392086(each), 40195327392087(case) 2 1019532754937440195327549375Lot Number: 23LBP488; 3) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case) 3 1019532754937440195327549375Lot Number: 25ABQ496; 4) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case) 4 1019532754937440195327549375Lot Number: 24CBI654; 5) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case) 5 1019532754937440195327549375Lot Number: 24DBU596; 6) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case) 6 1019532754937440195327549375Lot Number: 24FBA388; 7) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case) 7 1019532754937440195327549375Lot Number: 24GBD436; 8) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case) 8 1019532754937440195327549375Lot Number: 24JBC974; 9) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case) 9 1019532754937440195327549375Lot Number: 24KBA645; 10) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case) 10 1019845936266840198459362669Lot Number: 23LBB037; 11) DYKS1216I, UDI-DI: 10198459362668(each), 40198459362669(case) 11 1019532754934340195327549344Lot Number: 25GBP888; 12) DYKS1325A, UDI-DI: 10195327549343(each), 40195327549344(case) 12 1019532754934340195327549344Lot Number: 25ABT088; 13) DYKS1325A, UDI-DI: 10195327549343(each), 40195327549344(case) 13 1019532754934340195327549344Lot Number: 24KBO407; 14) DYKS1325A, UDI-DI: 10195327549343(each), 40195327549344(case) 14 1019532754934340195327549344Lot Number: 24ABO808; 15) DYKS1325A, UDI-DI: 10195327549343(each), 40195327549344(case) 15 1019532754934340195327549344Lot Number: 24CBI736; 16) DYKS1325A, UDI-DI: 10195327549343(each), 40195327549344(case) 16 1019532754934340195327549344Lot Number: 24EBN336; 17) DYKS1325A, UDI-DI: 10195327549343(each), 40195327549344(case) 17 1019845902766640198459027667Lot Number: 24IBP255; 18) DYKS1583, UDI-DI: 10198459027666(each), 40198459027667(case) 18 1019845902765940198459027650Lot Number: 24GBW364; 19) DYKS1584, UDI-DI: 10198459027659(each), 40198459027650(case) 19 1019845914663340198459146634Lot Number: 24GBW365; 20) DYKS1584A, UDI-DI: 10198459146633(each), 40198459146634(case) 20 1019845929275040198459292751Lot Number: 24JBA740; 21) DYKS1584B, UDI-DI: 10198459292750(each), 40198459292751(case) - Amount recalled
- 13032 kits
This recall covers 29 products
The agency filed one notice per product. You are reading one of them; the other 28 are below.
16 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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