Medline medical procedure kits recalled for elevated endotoxin levels
Medline Industries is recalling 208 medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels that may exceed product specifications.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 with a high-risk contamination hazard (endotoxin) that poses a risk of patient harm. The source text does not report any illnesses or injuries, so the theoretical hazard without reported adverse events places it at the High severity level per the rubric.
Plain-English summary
Medline Industries, LP is recalling 208 Medline medical procedure kits that contain Medline Neuro Sponges. The two affected kit types are the OSC COLEMAN FAT HARVEST KIT (Medline Kit Number/SKU DYNJ32854B) and the RR-DR. CHHETRI MDL PACK (Medline Kit Number/SKU DYNJ62635B, variants DYNJ62635C).
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. Endotoxins are bacterial contaminants that can cause adverse reactions in patients.
The recalled kits have been distributed worldwide. Specific lot numbers affected include, for DYNJ32854B: 25GBU656; for DYNJ62635B: 25GMD214, 25FMC376, 25DMJ030, 25BME902, 25AMJ032, 24IMH612, 24EME486, 24DMD315; and for DYNJ62635C: 26BMD607, 25JMD196.
Healthcare facilities and professionals who received these kits should stop using them and contact Medline Industries, LP for instructions on returns or replacements.
The recalled product
- Product
- Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OSC COLEMAN FAT HARVEST KIT, Medline Kit Number/SKU DYNJ32854B; 2. RR-DR. CHHETRI MDL PACK, Medline Kit Number/SKU DYNJ62635B.
- Manufacturer
- Medline Industries, LP
- Hazard
- Affected units
- 208
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 (17)
- Medline Kit Number/SKU DYNJ32854B: UDI/DI each 10198459413414
- UDI/DI case 40198459413415
- Lot Number : 25GBU656
- Medline Kit Number/SKU DYNJ62635B: UDI/DI each 10195327634780
- UDI/DI case 40195327634781
- Lot Number : 25GMD214
- Lot Number : 25FMC376
- Lot Number : 25DMJ030
- Lot Number : 25BME902
- Lot Number : 25AMJ032
- Lot Number : 24IMH612
- Lot Number : 24EME486
- Lot Number : 24DMD315
- Medline Kit Number/SKU DYNJ62635C: UDI/DI each 10198459485619
- UDI/DI case 40198459485610
- Lot Number : 26BMD607
- Lot Number : 25JMD196.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 31 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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