Medline medical procedure kits with neuro sponges recalled for endotoxin
Medline Industries is recalling medical procedure kits containing neuro sponges after internal review identified higher-than-expected endotoxin levels. 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 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 medical device recall. The hazard (endotoxin) is a high-risk contaminant on surgical/procedural devices, but the source text does not report any illnesses or injuries, making it a theoretical risk of harm. Per the rubric, this corresponds to a High (3) severity.
Plain-English summary
Medline Industries, LP is recalling Medline medical procedure kits containing Medline Neuro Sponges. The affected kits include five models: SPINE PROCEDURES PACK-LF (Kit Number DYNJ0751220P), ENSEMBLE RACHIS-LF (Kit Number DYNJ47568B), and three UROLOGY ROBOTIC kits (Kit Numbers DYNJ55555B, DYNJ55555C, and DYNJ55555D). Approximately 4,324 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. Endotoxin contamination on medical devices can pose a risk to patient safety, particularly for devices used in surgical procedures.
Customers who have received affected kits should review the lot numbers provided and contact Medline Industries, LP with any questions. Patients should consult their healthcare provider or physician if they have received a procedure using one of the recalled kits.
The recalled product
- Product
- Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. SPINE PROCEDURES PACK-LF, Medline Kit Number/SKU DYNJ0751220P; 2. ENSEMBLE RACHIS-LF, Medline Kit Number/SKU DYNJ47568B; 3. UROLOGY ROBOTIC, Medline Kit Number/SKU DYNJ55555B; 4.…
- Manufacturer
- Medline Industries, LP
- Hazard
- Affected units
- 4,324
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 DYNJ0751220P: UDI/DI each 10193489815122
- UDI/DI case 40193489815123
- Lot Number: 22EMB486
- Lot Number: 22CMI117
- Lot Number: 22CMB218
- Lot Number: 22CMB219
- Lot Number: 21LMA406
- Lot Number: 21LMA805
- Lot Number: 21JMF667
- Lot Number: 21IMF752
- Lot Number: 21HMG136
- Lot Number: 21HMB278
- Lot Number: 21GMD367
- Lot Number: 21CKA503
- Lot Number: 21AKA471
- Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058
- UDI/DI case 40193489846059
- Lot Number: 23JBT331
- Lot Number: 23IBL993
- Lot Number: 23GBN118
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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