Medline Microdisectomy Kits Recalled for High Endotoxin Levels
Medline is recalling Microdisectomy Packs containing Neuro Sponges due to higher-than-expected endotoxin levels found during an internal review. The affected products 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 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 a risk-of-harm medical device (elevated endotoxin on sterile surgical sponges) where no illnesses or injuries have been reported. Per the rubric, this qualifies as High (score 3).
Plain-English summary
Medline Industries, LP is recalling Medline Microdisectomy Packs (Kit Numbers DYNJ80585B, DYNJ80585C, and DYNJ80585D) containing Medline Neuro Sponges. A total of 924 kits have been distributed worldwide.
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. Endotoxins are bacterial contaminants that can pose a risk to patient safety when present at elevated levels in medical devices used in sterile procedures.
Affected lot numbers include: For DYNJ80585B: 22GBV101 and 24IBG473; for DYNJ80585C: 25EBT656, 25DBN421, 25CBN640, 25BBL172, 25BBD651, 25ABA455, 24KBO858, and 24JBH693; for DYNJ80585D: 26ABH754, 25LBA242, 25HBT362, 25GBL430, and 25FBT402.
Healthcare providers and facilities should immediately stop using these kits and contact Medline Industries, LP for instructions on product return or replacement.
The recalled product
- Product
- Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585B; 2. MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585C; 3, MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585D.
- Manufacturer
- Medline Industries, LP
- Affected units
- 924
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 DYNJ80585B: UDI/DI each 10195327211158
- UDI/DI case 40195327211159
- Lot Number: 22GBV101
- Lot Number: 24IBG473
- Medline Kit Number/SKU DYNJ80585C: UDI/DI each 10198459154751
- UDI/DI case 40198459154752
- Lot Number: 25EBT656
- Lot Number: 25DBN421
- Lot Number: 25CBN640
- Lot Number: 25BBL172
- Lot Number: 25BBD651
- Lot Number: 25ABA455
- Lot Number: 24KBO858
- Lot Number: 24JBH693
- Medline Kit Number/SKU DYNJ80585D: UDI/DI each 10198459389337
- UDI/DI case 40198459389338
- Lot Number: 26ABH754
- Lot Number: 25LBA242
- Lot Number: 25HBT362
- Lot Number: 25GBL430
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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