Recall archive / FDA device enforcement
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: CERVICAL PACK, Medline Kit Numb... — FDA record Z-2029-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 19, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: CERVICAL PACK, Medline Kit Number/SKU DYNJ37902F
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Medline Industries, LP
- Quantity
- 340 kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2029-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI/DI each 10889942930883, UDI/DI case 40889942930884, Lot Numbers: 21GBA316, 21FBA411, 21DBI004, 21BBS142. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- May 6, 2026
- Recall initiation date
- Mar 19, 2026
- Center classification date
- Apr 30, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.