Medline Neuro Sponges recalled for higher-than-expected endotoxin levels
Medline Industries is recalling medical procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels that may exceed specifications.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall where the hazard—elevated endotoxin levels in sterile surgical sponges—presents a risk of harm (potential pyrogenic or infection-related complications) without reported illnesses or injuries documented in the source text.
Plain-English summary
Medline Industries, LP is recalling Medline medical procedure kits containing Medline Neuro Sponges (labeled SPNG NEURO 1X1 10/PK XR, Kit Number/SKU DNSC38133). During an internal review, Medline identified higher-than-expected endotoxin levels on representative product samples, indicating that in-market product may be out-of-specification for endotoxin.
Approximately 10,400 kits have been distributed worldwide. The affected product is identified by UDI/DI case 40884389388656 and the following lot numbers: 22KDA794, 22JDB440, 22ADA361, 22ADA101, 21LDC095, 21LDA462, 21JDC613, 21JDB279, 21IDC073, 21FDA437, 21EDC004, 21EDC005, 21EDB599, 21DDA592, 21CDA826, and 21BDA565.
Consumers and medical facilities should stop using affected kits and contact Medline Industries for further instructions regarding this recall. For more information, visit the FDA recall notice at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=Z-2032-2026.
The recalled product
- Product
- Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPNG NEURO 1X1 10/PK XR, Medline Kit Number/SKU DNSC38133
- Manufacturer
- Medline Industries, LP
- Hazard
- endotoxin-contamination
- pyrogens
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (18)
- 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.
Distribution
Distribution scope not specified by the agency.
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