Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Mod
Pending LLM rewrite. Source: FDA_DEVICE Z-1418-2026.
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) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A; 3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J; 4) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807K; 5) MINOR VAGINAL #76-RF, Mod
- 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) CDS984086I
- UDI-DI: 10195327428006(each)
- 40195327428007(case)
- Lot Number: 24CBQ563
- 2) CDS984086I
- Lot Number: 24ABO363
- 3) CDS984086I
- Lot Number: 23IBV204
- 4) CDS984086I
- Lot Number: 23HBY878
- 5) CDS984086I
- Lot Number: 23GBE705
- 6) DYKMBNDL91A
- UDI-DI: 10195327246891(each)
- 40195327246892(case)
- Lot Number: 23HBI773
- 7) DYKMBNDL91A
- Lot Number: 23FBD256
- 8) DYKMBNDL91A
- Lot Number: 23FBC116
Distribution
Distributed nationwide across the United States.
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