Medline Neuro Sponges in Medical Procedure Kits Recalled for High Endotoxin
Medline Industries is recalling Medline medical procedure kits containing Neuro Sponges (EH BRONCHOSCOPY, Kit Number DYNJT3270) due to higher-than-expected endotoxin levels that may be out of specification.
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: This is an FDA Class II recall of a medical device with a potentially significant health hazard (elevated endotoxin levels in a product used in bronchoscopy procedures). The source explicitly states the product is out-of-specification with no reported illnesses, placing it at severity level 3 per the rubric for risk-of-harm medical devices.
Plain-English summary
Medline Industries, LP is recalling Medline medical procedure kits containing Medline Neuro Sponges labeled as EH BRONCHOSCOPY (Kit Number/SKU DYNJT3270). The affected product has been distributed worldwide.
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin. A total of 152 kits are affected across the lot numbers 26AMF231, 25GMC304, and 25DMF469.
Affected customers should discontinue use of the recalled kits and contact Medline Industries for further instructions regarding product disposition and replacement.
The recalled product
- Product
- Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: EH BRONCHOSCOPY, Medline Kit Number/SKU DYNJT3270
- Manufacturer
- Medline Industries, LP
- Hazard
- endotoxin-contamination
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 (5)
- UDI/DI each 10198459322235
- UDI/DI case 40198459322236
- Lot Numbers: 26AMF231
- 25GMC304
- 25DMF469.
Distribution
Distribution scope not specified by the agency.
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