Medline medical procedure kits recalled for endotoxin contamination
Medline is recalling medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels. The affected in-market product may be out-of-specification for endotoxin.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II medical device recall. The source text states only that in-market product "may be out-of-specification" for endotoxin with no reported injuries or illnesses. Per the rubric, Class II recalls without hospitalization or injury reports fall under Moderate severity.
Plain-English summary
Medline Industries, LP is recalling medical procedure kits that contain Medline Neuro Sponges. 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.
The recall affects 3,290 kits distributed worldwide. The affected products include multiple kit types with various SKUs (DYNJ48725A, DYNJ64138B, DYNJ64572A, DYNJ64572B, DYNJ67284A, DYNJ81411A, DYNJ84478, DYNJ85025, DYNJ89030, DYNJ902935K, DYNJ909065, and DYNJ909065A), each with specific lot numbers and UDI codes listed in the recall notice.
Patients or healthcare providers who have received or used these kits should contact Medline or their healthcare provider. For specific lot numbers and additional information, consult the FDA recall notice Z-2037-2026.
The recalled product
- Product
- Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. CATARACT PACK, Medline Kit Number/SKU DYNJ48725A; 2. OCULAR PACK, Medline Kit Number/SKU DYNJ64138B; 3. OCULOPLASTY PACK, Medline Kit Number/SKU DYNJ64572A; 4. OCULOPLASTY PACK…
- Manufacturer
- Medline Industries, LP
- Hazard
- Affected units
- 3,290
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 DYNJ48725A: UDI/DI each 10193489853896
- UDI/DI case 40193489853897
- Lot Number: 24IMG757
- Medline Kit Number/SKU DYNJ64138B: UDI/DI each 10193489355284
- UDI/DI case 40193489355285
- Lot Number: 22FME241
- Lot Number: 22DMC340
- Lot Number: 21JMC829
- Lot Number: 21IMC497
- Lot Number: 21HMD139
- Lot Number: 21GME747
- Lot Number: 21FMA440
- Lot Number: 21DBU602
- Lot Number: 21CBJ936
- Medline Kit Number/SKU DYNJ64572A: UDI/DI each 10195327112554
- UDI/DI case 40195327112555
- Lot Number: 23IBC227
- Lot Number: 23FBA458
- Lot Number: 23DBC239
- Lot Number: 23ABI841
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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