FDA Medical devices recall ·
Medline medical procedure kits, containing Medline Neuro Sponges… recall
- Recall number
- Z-2013-2026
- Date
- (initiated March 19, 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
- 413 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO PACK, Medline kit number/SKU DYNJ64479; 2. CRANIO/NEURO/SPINE, Medline kit number/SKU DYNJ901072D.
Why was it recalled?
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.
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
Medline Kit Number/SKU DYNJ86657A, UDI/DI each 10198459431678, UDI/DI case 40198459431679, Lot Number: 26ABM977; Medline Kit Number/SKU DYNJ86657A, UDI/DI each 10198459431678, UDI/DI case 40198459431679, Lot Number: 25KBM387; Medline Kit Number/SKU DYNJ86657A, UDI/DI each 10198459431678, UDI/DI case 40198459431679, Lot Number: 25IBG995; Medline Kit Number/SKU DYNJ86657A, UDI/DI each 10198459431678, UDI/DI case 40198459431679, Lot Number: 25GBW704; Medline Kit Number/SKU DYNJT3270, UDI/DI each 10198459322235, UDI/DI case 40198459322236, Lot Number: 26AMF231; Medline Kit Number/SKU DYNJT3270, UDI/DI each 10198459322235, UDI/DI case 40198459322236, Lot Number: 25GMC304.
Distribution
Worldwide distribution.
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-2013-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.