FDAClass IINovember 26, 2025

MEDLINE convenience kits labeled as: 1) BREAST BIOPSY recall

MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BIOPSY BREAST PACK, REF DYNJ65361A; 3) BREAST BIOPSY/MASTECTOMY…

Why was MEDLINE convenience kits labeled as: 1) BREAST BIOPSY recalled?

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

1) REF DYNJ0160598C: UDI/DI 10195327304270 (each), 40195327304271 (case), Lot Numbers: 23DDC250, 23GDA351; 2) REF DYNJ65361A: UDI/DI 10195327415051 (each), 40195327415052 (case), Lot Numbers: 24BMC296; 3) REF DYNJ908839A: UDI/DI 10195327431822 (each), 40195327431823 (case), Lot Numbers: 23GBL904, 23GBU981, 23HBF736, 23HBO368, 24BBP268, 24CBO698, 24EBS782.

Product
MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BIOPSY BREAST PACK, REF DYNJ65361A; 3) BREAST BIOPSY/MASTECTOMY…
Recalling firm
Medline Industries, LP
Quantity
301 units
Distribution
US Nationwide distribution.
Recall date
November 26, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls