Medline Medical Procedure Kits Recalled for High Endotoxin Levels
Medline is recalling medical procedure kits containing neuro sponges due to higher-than-expected endotoxin levels that may be out-of-specification. The kits were distributed worldwide.
What this means for you
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 sterile surgical devices with endotoxin contamination, a high-risk hazard for infection and patient harm. Although no illnesses or injuries are explicitly reported in the source, endotoxin is a known biological hazard capable of causing serious adverse reactions, placing this at the High level per the rubric.
Plain-English summary
Medline Industries, LP is recalling approximately 263,739 medical procedure kits containing Medline Neuro Sponges and other surgical components. 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.
The affected kits were distributed worldwide under multiple product numbers and lot numbers. Affected kit numbers include BIOB110, CDS780056M, CDS780056N, CDS840490K, CDS980523L, CDS980524I, CDS982683X, CDS982719X, CDS982744G, CDS982939V, CDS983067N, CDS983100C, CDS983115J, CDS983157J, CDS983178J, CDS983188L, CDS983467J, CDS983470I, CDS983799D, CDS984227A, CDS984229I, CDS984260K, CDS984263N, CDS985212B, CDS985227B, DYKM1073A, DYKMBNDL32C, DYNDA2085A, DYNJ0045920C, DYNJ0101287M, DYNJ0101287N, DYNJ0101287O, DYNJ0101292I, DYNJ0101292J, DYNJ0117497F, DYNJ0117497J, DYNJ0117497K, and DYNJ0151196G, with specific lot numbers documented.
Healthcare facilities and providers who have received affected kits should stop use and contact Medline for replacement or further instructions. Patients who may have received treatment with these kits should consult with their healthcare provider regarding potential exposure to elevated endotoxin levels.
The recalled product
- Product
- Medline medical procedure kits, containing Medline Neuro Sponges (1050 in total), BIOBURDEN TEST KIT, NEURO, ROBOTIC, ACDF, ENT, etc.
- Manufacturer
- Medline Industries, LP
- Hazard
- endotoxin
- contamination
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 BIOB110: UDI/DI each 10889942758043
- UDI/DI case 40889942758044
- Lot Number: 24HBM826
- Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562
- UDI/DI case 40195327045563
- Lot Number: 23KBK939
- Lot Number: 23JBD164
- Lot Number: 23HBJ252
- Lot Number: 23EBV328
- Lot Number: 23DBD983
- Lot Number: 23BBR624
- Lot Number: 23BBM647
- Lot Number: 23BBB199
- Lot Number: 23ABR879
- Lot Number: 23ABK516
- Lot Number: 22KBO464
- Lot Number: 22IBD725
- Lot Number: 22FBH811
- Lot Number: 22DBG358
- Lot Number: 22CBS385
Distribution
Distribution scope not specified by the agency.
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