Medline recalls surgical convenience kits due to potential contamination
Medline Industries is recalling 94 surgical convenience kits nationwide because they contain a potentially contaminated component.
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: The recall involves a potentially contaminated medical device component where no illnesses or injuries have been reported, fitting the rubric criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling 94 surgical convenience kits distributed across 18 U.S. states. The affected products include kits labeled as MAJOR PROCEDURE, OPERATIVE LAP P&S SURGICAL, and LAPAROSCOPY, identified by specific SKUs and lot numbers.
The recall was initiated because the kits contain a potentially contaminated component. The source text does not specify the nature of the contamination or report any illnesses or injuries associated with the use of these products.
Healthcare facilities and consumers who possess these specific kits should stop using them and contact Medline Industries for further instructions on return or disposal.
The recalled product
- Product
- Medline convenience kits labeled as: 1) MAJOR PROCEDURE, Medline Kit SKU CDS982040U; 2) OPERATIVE LAP P&S SURGICAL, Medline Kit SKU DYNJ89608; 3) LAPAROSCOPY, Medline Kit SKU DYNJ903479L; 4) LAPAROSCOPY, Medline Kit SKU DYNJ903479M.
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 94
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 (12)
- Medline Kit SKU CDS982040U
- UDI/DI 10198459385421 (each) 40198459385422 (case)
- Lot Number 26AMC355
- Medline Kit SKU DYNJ89608
- UDI/DI 10198459279324 (each) 40198459279325 (case)
- Lot Number 25JBR465
- Medline Kit SKU DYNJ903479L
- UDI/DI 10198459255250 (each) 40198459255251 (case)
- Lot Number 25LMB480
- Medline Kit SKU DYNJ903479M
- UDI/DI 10198459790591 (each) 40198459790592 (case)
- Lot Number 26FMB173.
Distribution
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