Medline Convenience Kits Surgical Packaging Sterilization Calibration Issue
Medline Industries is recalling over 7,700 surgical convenience kits due to calibration issues with sterilization and packaging equipment that may affect 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: This is an FDA Class II recall involving sterile surgical devices where calibration defects create a potential risk to sterility assurance level. Although no reported injuries or illnesses are stated in the source, the theoretical risk involves exposure of surgical instruments to compromised sterilization—a high-risk scenario for patient harm in surgical settings.
Plain-English summary
Medline Industries, LP is recalling multiple models of Medline Convenience Kits, including ophthalmic, cataract, vitrectomy, breast reconstruction, and other surgical procedure kits. The kits are designed for use in surgical procedures and are distributed worldwide with US nationwide distribution. A total of 7,760 units have been identified in the recall.
The recall was initiated due to calibration issues with the equipment used to sterilize and package these devices. While all products were exposed to validated sterilization and packaging cycles, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the recalled products.
Affected individuals who have received these kits should contact their supplier or Medline Industries for guidance on replacement or return of affected products. Healthcare facilities and providers using these kits should verify lot numbers against the detailed product listing provided by the manufacturer.
The recalled product
- Product
- Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104; 2) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104A; 3) KIT OPHTHALMOLOGY CORNEAL TRAN, Model Number: DYKMBNDL159; 4) KIT OPHTHALMOLOGY CATARACT, Model Number: DYKMBNDL180; 5)…
- Manufacturer
- Medline Industries, LP
- Affected units
- 7,760
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) DYKMBNDL104
- UDI-DI: 10193489478945(each)
- 40193489478946(case)
- Lot Number: 21ABV400
- 2) DYKMBNDL104
- Lot Number: 21FBP706
- 3) DYKMBNDL104
- Lot Number: 21IBV636
- 4) DYKMBNDL104
- Lot Number: 22GBP895
- 5) DYKMBNDL104A
- UDI-DI: 10195327240622(each)
- 40195327240623(case)
- Lot Number: 22HBX475
- 6) DYKMBNDL104A
- Lot Number: 22JBS899
- 7) DYKMBNDL104A
- Lot Number: 22JBS907
- 8) DYKMBNDL104A
- Lot Number: 22KBO773
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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