Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84A; 2) KIT SURG
Pending LLM rewrite. Source: FDA_DEVICE Z-1392-2026.
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 SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP, Model Number: DYKMBNDL87A; 3) CT BIOPSY TRAY, Model Number: DYNDH1143C; 4) BIOPSY SPECIALS PACK, Model Number: DYNDH1873; 5) BIOPSY SPECIALS PACK, Model
- 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) DYKMBNDL84A
- UDI-DI: 10195327240486(each)
- 40195327240487(case)
- Lot Number: 23ABK216
- 2) DYKMBNDL84A
- Lot Number: 22IBU924
- 3) DYKMBNDL84A
- Lot Number: 22IBQ267
- 4) DYKMBNDL87A
- UDI-DI: 10195327240479(each)
- 40195327240470(case)
- Lot Number: 23CBL439
- 5) DYKMBNDL87A
- Lot Number: 23CBC364
- 6) DYKMBNDL87A
- Lot Number: 23ABU170
- 7) DYKMBNDL87A
- Lot Number: 22LBM302
- 8) DYKMBNDL87A
- Lot Number: 22LBK913
Distribution
Distributed nationwide across the United States.
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