FDA-Device2025-12-24Class IIPACKAGING DEFECT
Medline sterile Kelly forceps recalled for weak packaging seals and infection risk
Nationwide distributionMedical devices
What this means
Medline Industries' sterile Kelly forceps (5.5 inch, Item DYNJ04048) may have packaging seals that don't hold properly. If the seal fails, the sterile barrier is broken, which could allow bacteria or other germs to contaminate the instrument and increase infection risk if used.
- Stop using this product immediately if you have it
- Check your inventory for Item Number DYNJ04048 and Lot 2023112290
- Contact Medline Industries for instructions on returning or replacing the affected forceps
- Do not open or use any units from this lot
The agency's original wording
Hazard
The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states CA, CO, IL, KS, and MI.
Affected count
53 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0922-2026More 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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