Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPNG NEURO 1X1 10/PK XR, Medline Kit Number/SKU DNSC38133
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI/DI each 10884389388655, UDI/DI case 40884389388656, Lot Numbers: 22KDA794, 22JDB440, 22ADA361, 22ADA101, 21LDC095, 21LDA462, 21JDC613, 21JDB279, 21IDC073, 21FDA437, 21EDC004, 21EDC005, 21EDB599, 21DDA592, 21CDA826, 21BDA565.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medline Industries, LP
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPNG NEURO 1X1 10/PK XR, Medline Kit Number/SKU DNSC38133
Product Codes/Lot Numbers:
UDI/DI each 10884389388655, UDI/DI case 40884389388656, Lot Numbers: 22KDA794, 22JDB440, 22ADA361, 22ADA101, 21LDC095, 21LDA462, 21JDC613, 21JDB279, 21IDC073, 21FDA437, 21EDC004, 21EDC005, 21EDB599, 21DDA592, 21CDA826, 21BDA565.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2032-2026
Related Recalls
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.