Medline Industries, Inc. DYNJ0843339ORecalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

3 FDA recall records name this device's identifier, 3 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 19, 2026Open, Classified

   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.

   Z-2027-2026 · Root cause: Under Investigation by firm · FDA record ↗

2. Feb 27, 2026Open, Classified

   Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

   Z-2590-2026 · Root cause: No Marketing Application · FDA record ↗

3. Oct 9, 2024Open, Classified

   Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

   Z-0635-2025 · Root cause: Under Investigation by firm · FDA record ↗