Medline Industries, Inc. DYNJ82103ARecalls & reported problems

Summary

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

2 FDA recall records name this device's identifier, 2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Mar 19, 2026Class IIOpen, 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-2033-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Feb 27, 2026Class IIOpen, 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-2586-2026 · Root cause: No Marketing Application · Recall details · FDA record ↗