Medline pre-op surgical kits recalled for potential sterility breach in ChloraPrep applicators
What this means
Medline pre-op and cataract surgery kits containing BD ChloraPrep Clear applicators may have compromised sterile packaging due to wrinkles in the paper lidding. If the sterile barrier is breached, patients could be exposed to microbial contamination during surgery.
- Check your kit lot number against the FDA recall list
- Do not use affected kits for surgery
- Contact your healthcare facility or Medline for replacement kits
- Report any infections or complications to your healthcare provider
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-3058-2026More 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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