Medline Medical Procedure Kits Recalled for High Endotoxin Levels
Medline Industries is recalling medical procedure kits containing Neuro Sponges because of higher-than-expected endotoxin levels that may render the product out-of-specification.
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 involving potential endotoxin contamination on medical devices used in high-risk procedures (endoscopy, ENT, skull base surgery). Although no adverse events are reported in the source text, the risk of harm from elevated endotoxin levels on devices used in sensitive anatomical areas meets the High threshold.
Plain-English summary
Medline Industries, LP is recalling Medline medical procedure kits containing Medline Neuro Sponges. The affected kits include ENDOSCOPY-LF, ENDOSCOPY PACK, ENT PK 1008847, ENDO SINUS PACK, ENT, SEPTO/ENDO, and ENDOSCOPIC SKULL BASE kits with various lot numbers. The kits have been distributed worldwide.
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product. This indicates that in-market product may be out-of-specification for endotoxin. Endotoxin is a bacterial substance that can trigger adverse immune responses if present at elevated levels on devices intended for use in sensitive anatomical areas.
Patients who have received these devices or healthcare facilities that have used these kits should contact Medline Industries, LP with questions. Healthcare providers and facilities are advised to review their inventory of affected kits and consult the recall notice for specific lot numbers and product codes to identify potentially affected units.
The recalled product
- Product
- Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPY-LF, Medline Kit Number/SKU DYNJ22890M; 2. ENDOSCOPY PACK, Medline Kit Number/SKU DYNJ40645B; 3. ENT PK 1008847, Medline Kit Number/SKU DYNJ42319C; 4. ENDO SINUS PACK…
- Manufacturer
- Medline Industries, LP
- Hazard
- Affected units
- 2,153
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 (20)
- Medline Kit Number/SKU DYNJ22890M: UDI/DI each 10193489766486
- UDI/DI case 40193489766487
- Lot Number: 23DBM600
- Lot Number: 22JBM081
- Lot Number: 22ABJ346
- Lot Number: 21KBO873
- Lot Number: 21KBO877
- Lot Number: 21JBX107
- Lot Number: 21BBE213
- Lot Number: 21BBB024
- Medline Kit Number/SKU DYNJ40645B: UDI/DI each 10193489292183
- UDI/DI case 40193489292184
- Lot Number: 22AMD386
- Lot Number: 21LMC822
- Lot Number: 21JMF409
- Lot Number: 21IMC184
- Lot Number: 21GMB555
- Lot Number: 21EMD626
- Lot Number: 21CMC668
- Lot Number: 21AMB081
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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