Medline Surgical Biopsy Kits Recall
Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP, Model Number: DYKMBND
Updated January 7, 2026
Medline is recalling multiple surgical and biopsy kits due to potential sterilization issues. Equipment calibration problems could affect whether these sterile instruments remain free of contamination.
Is the Medline Industries, LP recalled? Yes. This product was recalled by FDA on January 7, 2026. Details below.
What is recalled
Medline Convenience Kits and biopsy packs: KIT SURG ONC EXCISION BREAST (Model DYKMBNDL84A), KIT SURG ONC EXPLORATORY LAP (Model DYKMBNDL87A), CT BIOPSY TRAY (Model DYNDH1143C), BIOPSY SPECIALS PACK (Models DYNDH1873 and DYNDH1934), BREAST BIOPSY PACK (Model DYNJ17489I), VOR PACK-LF (Models DYNJ48539 and DYNJ48539A), IR BIOPSY PACK (Model DYNJ59897B), and BREAST PACK (Model DYNJ82998).
Am I affected
You're affected if you use any Medline surgical or biopsy kit with one of these model numbers: DYKMBNDL84A, DYKMBNDL87A, DYNDH1143C, DYNDH1873, DYNDH1934, DYNJ17489I, DYNJ48539, DYNJ48539A, DYNJ59897B, or DYNJ82998.
What to do right now
Stop using these kits and contact your Medline supplier or healthcare facility immediately to arrange replacement or return of the recalled products.
The hazard
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.
Brands affected
- Source
- FDA
- Category
- Medical Devices
- Recall ID
- fda-Z-1392-2026
- Classification
- Class II
- Recalled
- January 7, 2026
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