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Medline Surgical and Biopsy Convenience Kits
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MEDICAL DEVICE RECALLMODERATE

Medline Surgical and Biopsy Convenience Kits

Medline is recalling various surgical and biopsy convenience kits due to potential issues with the sterility assurance level.

What to do

Stop using the affected kits immediately and contact Medline Industries for return and replacement instructions.

Recalled
Listed
Updated
Recall No.
Z-1388-2026
Agency
FDA
Firm
Medline Industries, LP
Recall ID
98329
Status
ONGOING

Why it was recalled

Medline Industries is recalling various surgical and biopsy convenience kits due to sterilization equipment calibration issues that may compromise the sterility assurance level of the products. The affected kits include surgical oncology, biopsy, and procedural packs distributed nationwide.

Is mine affected?

This recall covers 11 products. Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductModel
KIT SURG ONC EXCISION BREASTDYKMBNDL84A
KIT SURG ONC EXPLORATORY LAPDYKMBNDL87A
CT BIOPSY TRAYDYNDH1143C
BIOPSY SPECIALS PACKDYNDH1873
BREAST BIOPSY PACKDYNJ17489I
VOR PACK-LFDYNJ48539
IR BIOPSY PACKDYNJ59897B
BREAST PACKDYNJ82998
Show all 11 products
ProductModel
BIOPSY SPECIALS PACKDYNDH1934
VOR PACK-LFDYNJ48539A
KIT TRIPLE LUMEN INSERTIONDYNDM1031A

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other recent recalls from Medline Industries, LP

All recalls from Medline Industries, LP

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Editorial summary by Recall Canary · summary updated 2026-07-04 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification