FDA-Device2025-11-26Class IIPACKAGING DEFECT
MEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D; 2) REF: DYNJ37743F.
Hazard
Medline has identified specific sterile eye procedure kits with pouch packaging that may exhibit open seals.
Intended for
Adults
Illnesses reported
None reported
Sold states
US: MO
Affected count
1024 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
MEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D; 2) REF: DYNJ37743F.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0510-2026More 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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