FDA Medical devices recall ·
Medline Convenience Kits: 1) MAJOR PACK recall
- Recall number
- Z-3266-2026
- Date
- (initiated August 10, 2026)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 128 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medline Convenience Kits: 1) MAJOR PACK, Catalog Number: DYNJ81325A
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
1) DYNJ81325A, UDI-DI: 10195327270360(each), 40195327270361(case), Lot Number: 23HBB258
Distribution
US Nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3266-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.