Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104; 2) KIT OPHT
Pending LLM rewrite. Source: FDA_DEVICE Z-1420-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
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) K
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Devices
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: 22GBP895
- 2) DYKMBNDL104
- Lot Number: 21IBV636
- 3) DYKMBNDL104
- Lot Number: 21FBP706
- 4) DYKMBNDL104
- Lot Number: 21ABV400
- 5) DYKMBNDL104A
- UDI-DI: 10195327240622(each)
- 40195327240623(case)
- Lot Number: 24EBU650
- 6) DYKMBNDL104A
- Lot Number: 23HBV380
- 7) DYKMBNDL104A
- Lot Number: 22KBO773
- 8) DYKMBNDL104A
- Lot Number: 22JBS907
Distribution
Distributed nationwide across the United States.
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