Medline eye and cataract preop kits recalled for potential sterility breach in applicators
What this means
Medline Convenience Kits (Eye Kit and Cataract Preop Kit models) contain sterilized applicators with a potential packaging defect—wrinkles in the paper lidding that may compromise the sterile barrier. If the packaging is breached, patients could be exposed to microbial contamination, ranging from no injury to infection.
- If you have received one of the affected kits (model numbers DYKM2751, DYKM2751A, DYKS1583A, or DYKS1583B), do not use it.
- Check the lot number on your kit against the recalled batches listed in the full recall notice.
- Contact your healthcare provider or Medline Industries for instructions on replacement or return.
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3061-2026More Medline recalls
- FDA-Device2026-09-09Medline Convenience Kits recalled for potential sterility breach in antiseptic applicators
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for contamination risk
- FDA-Device2026-09-09Medline Convenience Kits recalled for sterility packaging breach risk
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for defective packaging seals
- FDA-Device2026-09-09Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk
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