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 found on the products. Affected kits were distributed worldwide.
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 of a medical device used in surgical procedures with potential for contamination (elevated endotoxin). Endotoxin is a high-risk pathogen concern in medical devices; no illnesses are reported in the source text, placing it at the high end of the High category per the rubric.
Plain-English summary
Medline Industries, LP is recalling multiple lots of medical procedure kits containing Medline Neuro Sponges. 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.
The recall affects approximately 538,201 kits distributed worldwide across multiple kit numbers and lot codes. The affected products are identified by specific UDI/DI numbers and lot numbers listed in the recall notice. Affected kits include models CDS780056K, CDS780056L, CDS780109O, CDS780109Q, CDS780119W, CDS780208F, CDS780230K, CDS780230L, CDS780230M, CDS840193AA, CDS981327Q, CDS981327R, CDS981327S, CDS982598J, CDS982704N, CDS983067O, CDS983067P, CDS983067Q, CDS983067R, CDS983186J, CDS983186K, CDS983383G, CDS983383I, CDS983383J, CDS983383K, CDS983383L, CDS983882D, CDS983882I, CDS983885D, CDS983885F, CDS983885I, CDS983981J, CDS983981K, and CDS983981L, each with their corresponding lot numbers.
Hospitals, surgical facilities, and healthcare providers who received these kits should check product lot numbers against the recall list. Consumers and healthcare facilities should stop using affected products and contact Medline Industries for additional information on returns or replacement.
The recalled product
- Product
- Medline medical procedure kits, containing Medline Neuro Sponges (961 in total), NEURO,
- Manufacturer
- Medline Industries, LP
- Hazard
- Affected units
- 538,201
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 CDS780056K: UDI/DI each 10888277941373
- UDI/DI case 40888277941374
- Lot Number: 21DBU610
- Medline Kit Number/SKU CDS780056L: UDI/DI each 10193489897593
- UDI/DI case 40193489897594
- Lot Number: 21KBG946
- Lot Number: 21IBV394
- Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865
- UDI/DI case 40193489332866
- Lot Number: 23IBO480
- Lot Number: 23FBL915
- Lot Number: 23EBP966
- Lot Number: 23DBB223
- Lot Number: 23CBO553
- Lot Number: 23ABG956
- Lot Number: 22KBD840
- Lot Number: 22IBK666
- Lot Number: 22HBZ276
- Lot Number: 22GBK671
- Lot Number: 22FBI951
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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