Medline Convenience Kits Recalled for Potential Sterilization Calibration Issues
Medline Industries is recalling multiple convenience kits due to calibration issues with sterilization and packaging equipment that may compromise sterility assurance. Approximately 5,497 units were affected and 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: The recall is classified as FDA Class II. The source text explicitly states no illnesses or injuries have been reported, and the hazard is theoretical—the calibration issues have "potential" to impact sterility but are not confirmed failures. This matches the rubric criterion for Moderate severity.
Plain-English summary
Medline Industries, LP is recalling multiple Medline Convenience Kits, including plastic bins with miscellaneous kits, surgical kits for plastic, hernia, breast, urology, and abdominoplasty procedures, and associated components. The recall affects approximately 5,497 units that were distributed nationwide in the United States.
Medline identified calibration issues with 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 affected products.
Patients and healthcare facilities that received these products should contact Medline Industries for instructions. The complete list of affected model numbers and lot numbers is available through the FDA, including models ACC010499, CDS984853J, DYKMBNDL series components, DYNJ series components, and PHS806973G.
The recalled product
- Product
- See RES for complete list. Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) BREAST-HERNIA-PORT CDS-LF, Model Number: CDS984853J; 3) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117C; 4) KIT PLASTIC INSERT TISSUE EXPA, Model Number…
- Manufacturer
- Medline Industries, LP
- Affected units
- 5,497
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) ACC010499
- UDI-DI: 10193489845709(each)
- 40193489845700(case)
- Lot Number: 21DDA661
- 2) ACC010499
- Lot Number: 21FDA888
- 3) ACC010499
- Lot Number: 21GDB740
- 4) ACC010499
- Lot Number: 21HDB434
- 5) ACC010499
- Lot Number: 21JDB530
- 6) ACC010499
- Lot Number: 23HDB786
- 7) ACC010499
- Lot Number: 23IDB182
- 8) ACC010499
- Lot Number: 23LDC086
- 9) ACC010499
- Lot Number: 24IDA403
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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