Medline Surgical Convenience Kits Recalled Due to Sterilization Calibration Issues
Medline Industries has recalled multiple surgical convenience kits after discovering calibration issues with sterilization equipment that may impact the sterility assurance level of the devices. The kits include robotic surgery, gynecology, urology, and general surgical packs distributed nationwide.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall with no reported illnesses or injuries. The recall is precautionary based on a potential (not confirmed) impact to sterility assurance from equipment calibration issues. The source explicitly states only that calibration issues "have the potential to impact" SAL, with no evidence of actual sterilization failure or patient harm.
Plain-English summary
Medline Industries, LP is recalling 13,376 units of multiple Medline Convenience Kits used in surgical procedures. The recalled products include robotic surgery packs, gynecology and urology kits, lithotomy packs, and various surgical procedure packs with model numbers ranging from CDS982407N to DYNJT6424.
The recall was initiated due to calibration issues identified in the equipment used to sterilize and package these devices. Although all products were exposed to validated sterilization and packaging cycles, the calibration issues have the potential to impact the sterility assurance level (SAL) of the recalled products.
The recalled kits have been distributed nationwide and worldwide. Customers who have received these products should contact Medline Industries, LP for instructions on returns or replacement. Healthcare facilities using these products should verify the lot numbers against the recall list provided by the FDA.
The recalled product
- Product
- Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 3) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431J; 4) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431K; 5) TOT/ GYN…
- Manufacturer
- Medline Industries, LP
- Affected units
- 13,376
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)
- 1) CDS982407N
- UDI-DI: 10193489683004(each)
- 40193489683005(case)
- Lot Number: 21CBD150
- 2) CDS982407N
- Lot Number: 21DBO201
- 3) CDS985431J
- UDI-DI: 10195327336110(each)
- 40195327336111(case)
- Lot Number: 23BBG608
- 4) CDS985431J
- Lot Number: 23DBM469
- 5) CDS985431J
- Lot Number: 23FBA948
- 6) CDS985431K
- UDI-DI: 10195327451295(each)
- 40195327451296(case)
- Lot Number: 23GBL932
- 7) CDS985431K
- Lot Number: 23GBM332
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 42 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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