Angiography/angioplasty Kit
Recall Summary Medline is recalling angiography/angioplasty kits (ANGIO PACK-LF, SKU DYNJ0774765U) that contain neuro sponges with higher-than-expected endotoxin levels, which means the product may not meet safety specifications. The kits were distributed worldwide for use in medical procedures. This is a Class II recall, indicating a situation where use of the product could result in serious adverse health consequences or death.
- Product
- Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: ANGIO PACK-LF, Medline Kit Number/SKU DYNJ0774765U
- 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/139d1a39-578f-49df-ac77-31a886a1f089