Medline medical procedure kits recalled for elevated endotoxin levels
Medline Industries is recalling medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels detected during an internal review. Affected kits include the Major Neuro Pack-LF, Angiography Pack, and Neuro SEO models.
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: The recall involves a Class II medical device with a high-risk hazard (endotoxin contamination on sterile surgical products). The source text explicitly states no reported illnesses or injuries, making the hazard theoretical; however, endotoxin contamination on medical devices used in invasive procedures presents an inherent risk of harm, warranting a High severity rating per the rubric.
Plain-English summary
Medline Industries, LP is recalling medical procedure kits that contain Medline Neuro Sponges. The three affected kit types are: Major Neuro Pack-LF (SKU DYNJ0578916X), Angiography Pack (SKU DYNJ51637D), and Neuro SEO (SKU DYNJ65650). Approximately 3,170 kits have 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. Endotoxins are bacterial contaminants that can pose a health risk when present at elevated levels on medical devices used in procedures.
Healthcare facilities and providers who have received affected kits should stop using them and contact Medline Industries for instructions. Specific lot numbers and UDI codes are available through FDA documentation for inventory verification. Consumers with questions should consult with their healthcare provider or contact Medline directly.
The recalled product
- Product
- Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MAJOR NEURO PACK-LF, Medline Kit Number/SKU DYNJ0578916X; 2. ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ51637D; 3. NEURO SEO, Medline Kit Number/SKU DYNJ65650.
- Manufacturer
- Medline Industries, LP
- Affected units
- 3,170
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 DYNJ0578916X: UDI/DI each 10193489288384
- UDI/DI case 40193489288385
- Lot Number: 23IME618
- Lot Number: 23FMF542
- Lot Number: 23DMA094
- Lot Number: 23AMD730
- Lot Number: 22GMB685
- Lot Number: 22DMI233
- Lot Number: 22DMC612
- Lot Number: 24AMA230
- Medline Kit Number/SKU DYNJ51637D: UDI/DI each 10195327632106
- UDI/DI case 40195327632107
- Lot Number: 24GMI248
- Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642
- UDI/DI case 40193489285643
- Lot Number: 23JMK002
- Lot Number: 23JME739
- Lot Number: 23IBJ883
- Lot Number: 23EBO648
- Lot Number: 23ABT378
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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