Medline Industries, Lp: Ear, Nose, And Throat Surgical Tray
Recall Summary Medline is recalling 14 surgical kits used in ear, nose, and throat procedures because certain sponges in these kits contain higher-than-acceptable levels of endotoxin, a bacterial substance that can cause immune reactions. The affected kits were distributed nationwide to healthcare facilities. This is a Class I recall, the most serious classification.
- Recalling firm
- Medline Industries, LP
- Product
- Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit SKU DYNJ0966146F; 2) ENT PACK, Medline Kit SKU DYNJ40154D; 3) ENT PACK, Medline Kit SKU DYNJ40154F; 4) ENT SCOPE PACK, Medline Kit SKU DYNJ44480D; 5) ENT NASAL ORAL PACK MOSES, Medline Kit SKU DYNJ58928A; 6) HEAD & NECK PACK, Medline Kit SKU DYNJ83296; 7) TRANSPHENOIDAL PACK, Medline Kit SKU DYNJ89006; 8) SINUS, Medline Kit SKU DYNJ900537D; 9) SINUS, Medline Kit SKU DYNJ900537F; 10) ENT HEAD & NECK, Medline Kit SKU DYNJ903679F; 11) ENT HEAD & NECK, Medline Kit SKU DYNJ903679G; 12) ENT HEAD & NECK, Medline Kit SKU...
- Reason
- Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-07-08
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of AZ, CA, IA, ID, IL, IN, MA, MD, MI, MN, MO, MT, NY, OH, TX, WI, WY.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/0b7d66fb-2240-484d-b482-cc58f2d64174