Eye Tray
Recall Summary Medline is recalling 12 medical procedure kits used in eye, sinus, and neurological surgeries because they contain neuro sponges with higher-than-expected endotoxin levels. Endotoxin is a bacterial substance that can cause issues if present in medical devices. The affected kits were distributed worldwide and are identified by specific Medline kit numbers (DYNJ48725A, DYNJ64138B, DYNJ64572A, DYNJ64572B, DYNJ67284A, DYNJ81411A, DYNJ84478, DYNJ85025, DYNJ89030, DYNJ902935K, DYNJ909065, and DYNJ909065A).
- Product
- Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. CATARACT PACK, Medline Kit Number/SKU DYNJ48725A; 2. OCULAR PACK, Medline Kit Number/SKU DYNJ64138B; 3. OCULOPLASTY PACK, Medline Kit Number/SKU DYNJ64572A; 4. OCULOPLASTY PACK, Medline Kit Number/SKU DYNJ64572B; 5. MICROSURGERY PACK, Medline Kit Number/SKU DYNJ67284A; 6. BASIC EYE PACK, Medline Kit Number/SKU DYNJ81411A; 7. SMR SINUS PACK, Medline Kit Number/SKU DYNJ84478; 8. FESS/SEPTO PACK, Medline Kit Number/SKU DYNJ85025; 9. PLASTIC EYE PACK, Medline Kit Number/SKU DYNJ89030; 10. NEURO, Medline...
- Reason
- During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-03-19
- Status
- Open, Classified
- Distribution
- Worldwide distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/69800ced-db66-4047-8d25-de8fe35562b0