Medline PPE Kit recalled for sterilization calibration issues
Medline is recalling Convenience Kits (PPE Kit, Model DYK1011945P) due to calibration issues with sterilization and packaging equipment that may compromise sterility assurance. The product was 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 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: FDA classified this as a Class II recall, but the hazard involves potential loss of sterility assurance on medical devices—a high-risk situation. The source text does not report any illnesses or injuries, so per the rubric this scores at most 3, applying the "risk-of-harm" criterion where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling the Medline Convenience Kit (PPE Kit, Model Number DYK1011945P) distributed nationwide. The recall affects approximately 13,025 units across multiple lot numbers spanning from 2021 through 2025.
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 problems have the potential to impact the sterility assurance level (SAL) of the recalled products.
Consumers who have received this product should contact Medline Industries, LP for guidance on return or replacement of affected units. Healthcare facilities and distributors should quarantine affected lot numbers and report any patient exposure to Medline and their medical device supplier immediately.
The recalled product
- Product
- Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — PPE Kit
- Affected units
- 13,025
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) DYK1011945P
- UDI-DI: 10884389389973(each)
- 40884389389974(case)
- Lot Number: 21BFA109
- 2) DYK1011945P
- Lot Number: 21EFA047
- 3) DYK1011945P
- Lot Number: 21FFA074
- 4) DYK1011945P
- Lot Number: 21GFA025
- 5) DYK1011945P
- Lot Number: 21HFA112
- 6) DYK1011945P
- Lot Number: 21IFA100
- 7) DYK1011945P
- Lot Number: 21JFA039
- 8) DYK1011945P
- Lot Number: 21JFA139
- 9) DYK1011945P
- Lot Number: 21KFA114
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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