Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER
Pending LLM rewrite. Source: FDA_DEVICE Z-1396-2026.
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) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721
- 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) DYKE1455B
- UDI-DI: 10193489760781(each)
- 40193489760782(case)
- Lot Number: 22IBV801
- 2) DYKE1721
- UDI-DI: 10193489258684(each)
- 40193489258685(case)
- Lot Number: 23KMC417
- 3) DYKE1721
- Lot Number: 23IMF495
- 4) DYKE1721
- Lot Number: 23HMG566
- 5) DYKE1721
- Lot Number: 23GMF416
- 6) DYKE1721
- Lot Number: 23GMC067
- 7) DYKE1721
- Lot Number: 23EMF635
- 8) DYKE1721
- Lot Number: 23CMG332
Distribution
Distributed nationwide across the United States.
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