FDA DevicesClass II
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as fol...
Published: May 6, 2026Recall ID: Z-2029-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: CERVICAL PACK, Medline Kit Number/SKU DYNJ37902F
Affected Products
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: CERVICAL PACK, Medline Kit Number/SKU DYNJ37902F
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98664 |
| Address 1 | 3 Lakes Dr |
| Code info | UDI/DI each 10889942930883, UDI/DI case 40889942930884, Lot Numbers: 21GBA316, 21FBA411, 21DBI004, 21BBS142. |
| Postal code | 60093-2753 |
| Report date | 20260506 |
| Product type | Devices |
| Product quantity | 340 kits |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260319 |
| Initial firm notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Center classification date | 20260430 |
Overview
- Recalling FirmMedline Industries, LP
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution.