Reported Nov 26, 2025 · Ongoing
MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BIOPSY BREAST PACK, REF DYNJ65361A;…
Medline Industries, LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medline Industries, LP · 3 Lakes Dr · Northfield, IL · 60093-2753
Is this the product you have?
- MEDLINE convenience kits labeled as
1) BREAST BIOPSY PACK-LFREF DYNJ0160598C2) BIOPSY BREAST PACKREF DYNJ65361A3) BREAST BIOPSY/MASTECTOMYREF DYNJ908839A
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published DYNJ0160598C1019532730427040195327304271UDI/DI 10195327304270 (each), 40195327304271 (case), Lot Numbers: 23DDC250, 23GDA351 DYNJ65361A1019532741505140195327415052UDI/DI 10195327415051 (each), 40195327415052 (case), Lot Numbers: 24BMC296 DYNJ908839A1019532743182240195327431823UDI/DI 10195327431822 (each), 40195327431823 (case), Lot Numbers: 23GBL904, 23GBU981, 23HBF736, 23HBO368, 24BBP268, 24CBO698, 24EBS782. - Amount recalled
- 301 units
This recall covers 21 products
The agency filed one notice per product. You are reading one of them; the other 20 are below.
8 more are in the archive.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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