Warning
Medline Industries Recalls Medline medical procedure kits
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-2036-2026Medical Device
Medline Industries Recalls Medline medical procedure kits
Medline Industries, LP · Class II — Moderate Risk
Product Description
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ANTERIOR CERVICAL FUSION PACK, Medline Kit Number/SKU DYNJ40566C; 2. OB PACK (OBSJD)642-LF, Medline Kit Number/SKU DYNJ47491F; 3. ANTERIOR CERVICAL-LF, Medline Kit Number/SKU DYNJ58274; 4. ANTERIOR CERVICAL-LF, Medline Kit Number/SKU DYNJ58344; 5. ANTERIOR CERVICAL-LF, Medline Kit Number/SKU DYNJS3016.
Reason for Recall
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.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Worldwide distribution.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA classified this recall as Class II, indicating the medical device may cause temporary health problems or poses a slight threat of a serious nature. Medline Industries, LP initiated the recall on March 19, 2026 affecting 7004 kits. 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. The product was distributed internationally. Consumers should check their purchases and discontinue use of any affected product. Contact Medline Industries, LP for further instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination and Medline Industries recalls.