Medline and Centurion Medical Procedure Kits Recalled for High Endotoxin Levels
Medline Industries is recalling Medline and Centurion medical procedure kits containing neuro sponges due to higher-than-expected endotoxin levels that may cause the products to be out-of-specification.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving medical devices that may pose a health risk due to endotoxin contamination, which can cause serious reactions in patients. Although no illnesses are explicitly reported in the source text, the FDA's own Class II classification for a device used in surgical procedures involving the nervous system and head/neck indicates serious potential for harm.
Plain-English summary
Medline Industries, LP is recalling Medline and Centurion medical procedure kits containing Medline Neuro Sponges. The recall affects approximately 486,946 kits distributed worldwide, including models AM310B, CDS980579D, CDS980579F, CDS981185B, CDS981692J, CDS982020R, CDS982020S, CDS982020T, CDS982596L, CDS982598K, CDS982901F, CDS982901G, CDS982939Q, CDS982939R, CDS982939S, CDS982939T, CDS983087G, CDS983100F, CDS983100G, CDS983178D, CDS983178F, CDS983178G, CDS983178I, CDS983290B, CDS983302I, CDS983302J, CDS983483I, CDS983483J, CDS983486G, CDS983486I, CDS983486K, and CDS983486L, with specific lot numbers identified by the manufacturer.
During an internal review, Medline identified higher-than-expected endotoxin levels on representative neuro sponge products, indicating that in-market product may be out-of-specification for endotoxin. Endotoxin is a bacterial component that can cause adverse reactions if present in medical devices.
Healthcare facilities and medical professionals in possession of affected kits should stop use and contact Medline Industries for further instructions regarding the recalled products. The FDA classified this recall as Class II on January 27, 2021.
The recalled product
- Product
- Medline and Centurion medical procedure kits, containing Medline Neuro Sponges (1229 in total), HEAD & NECK TRAY, SINUS, SMR, etc.
- Manufacturer
- Medline Industries, LP
- Affected units
- 486,946
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 AM310B: UDI/DI each 10193489242126
- UDI/DI case 40193489242127
- Lot Number: 20XBG776
- Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710
- UDI/DI case 40889942133711
- Lot Number: 23JBF547
- Lot Number: 23GBK604
- Lot Number: 23DBO915
- Lot Number: 23DBD581
- Lot Number: 23ABP476
- Lot Number: 23ABD648
- Lot Number: 22LBE888
- Lot Number: 22HBL188
- Lot Number: 22HBF976
- Lot Number: 22FBN678
- Lot Number: 22DBK641
- Lot Number: 22BBU367
- Lot Number: 22ABD373
- Lot Number: 21JBC146
- Lot Number: 21IBA072
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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