Medline Surgical Patties and Strips Recalled for Out-of-Spec Endotoxin Contamination
Medline is recalling surgical patties and strips in custom surgical kits due to higher-than-expected endotoxin levels in raw materials. These may result in out-of-specification endotoxin levels in finished sterile products.
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 a Class II FDA recall involving confirmed endotoxin contamination in sterile surgical kits. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products without reported injury score as High (3).
Plain-English summary
Medline Industries, LP is recalling surgical patties and strips contained in multiple custom neurological surgical convenience kits. The affected products include 25 different kit SKUs distributed across the United States and Canada, totaling 12,889 kits.
The recall was initiated after testing revealed higher-than-expected endotoxin levels in the raw material used to manufacture the sterile Codman Surgical Patties and Strips. The contamination has resulted in out-of-specification endotoxin levels in certain finished kits used in neurological surgical procedures.
The recalled product
- Product
- Medline brand, medical procedure convenience kits, labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119T; 2) NEURO KIT, SKU CDS981327Q; 3) NEURO POSTERIOR SPINE PACK-LF, SKU DYNJ0311501I; 4) ACOUSTIC NEUROMA PACK-LF, SKU DYNJ37741D; 5) SCRIPPS SW NEURO PACK-LF, SKU…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 12,889
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)
- UDI-DI: CDS780119T
- 10888277762688 (each)
- 40888277762689 (case)
- Lot Numbers: 20EBU829
- UDI-DI: CDS981327Q
- 10195327080365 (each)
- 40195327080366 (case)
- Lot Numbers: 22FMH830 22FMF883
- UDI-DI: DYNJ0311501I
- 10889942265886 (each)
- 40889942265887 (case)
- Lot Numbers: 22DMF117
- UDI-DI: DYNJ37741D
- 10195327548940 (each)
- 40195327548941 (case)
- Lot Numbers: 24EMD032
- UDI-DI: DYNJ39836C
- 10193489510324 (each)
- 40193489510325 (case)
- Lot Numbers: 20JMB588 20GMD367 20EMB420 20CMC383 20CMA256
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by MEDLINE INDUSTRIES, LP - Northfield 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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