Recall Z-3266-2026— Medline Industries, LP
Class II · Ongoing
Class II FDA medical device recall by Medline Industries, LP, initiated 2026-08-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Medline Convenience Kits: 1) MAJOR PACK, Catalog Number: DYNJ81325A. Reason: The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea..
- Recalling firm
- Medline Industries, LP
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-08-10
- Firm location
- Northfield, IL, United States
Product description
Medline Convenience Kits: 1) MAJOR PACK, Catalog Number: DYNJ81325A
Reason for recall
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.
Data sourced from openFDA. This site is unofficial and independent of the FDA.