Medline Convenience Kits Recalled Due to Potential Sterility Assurance Issues
Medline Industries, LP is recalling various Medline Convenience Kits because equipment calibration issues may have impacted the sterility assurance level of the 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: The recall involves medical devices where a potential loss of sterility poses a high risk of harm, though no injuries have been reported.
Plain-English summary
Medline Industries, LP has identified issues related to the calibration of equipment used to sterilize and package several Medline Convenience Kits. While 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 affected products include various Medline Convenience Kits, such as knee arthroscopy, hand repair, and hip arthroscopy kits, across multiple model numbers. This recall affects approximately 1,496 units distributed nationwide in the US.
Users should check their inventory for the specific model and lot numbers listed in the recall notice to determine if they have been affected.
The recalled product
- Product
- Medline Convenience Kits: 1) TOTE ABRAMS KNEE ARTHROSCOPY, Model Number: DYKM1801B; 2) TOTE SEN OSC HAND REPAIR, Model Number: DYKM1776; 3) TOTE MOMENI SB CAPSULOTOMY REC, Model Number: DYKM1765A; 4) TOTE YAO OSC HAND REPAIR, Model Number: DYKM1796A; 5) TOTE SB NGUYEN…
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 1,496
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) DYKM1801B
- UDI-DI: 10653160360421(each)
- 00653160360424(case)
- Lot Number: 2024100790
- 2) DYKM1776
- UDI-DI: 10888277733794(each)
- 20888277733791(case)
- Lot Number: 2025013190
- 3) DYKM1765A
- UDI-DI: 10193489190236(each)
- 20193489190233(case)
- Lot Number: 2024071790
- 4) DYKM1796A
- UDI-DI: 10653160354888(each)
- 00653160354881(case)
- Lot Number: 2024072390
- 5) DYKM1756A
- UDI-DI: 10193489190250(each)
- 20193489190257(case)
- Lot Number: 2024080190
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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