Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST Recalled by Medline Industries, LP Due to Medline has identified issues related to calibration of...

Date: January 7, 2026
Company: Medline Industries, LP
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medline Industries, LP directly.

Affected Products

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 Number: DYNDH1934; 6) BREAST BIOPSY PACK, Model Number: DYNJ17489I; 7) VOR PACK-LF, Model Number: DYNJ48539; 8) VOR PACK-LF, Model Number: DYNJ48539A; 9) IR BIOPSY PACK, Model Number: DYNJ59897B; 10) BREAST PACK, Model Number: DYNJ82998

Quantity: 2740 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Medline Industries, LP

Medline Industries, LP has 182 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report