Medline Industries, LP recalls MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF

Recalling company

Medline Industries, LP

Product

MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BIOPSY BREAST PACK, REF DYNJ65361A; 3) BREAST BIOPSY/MASTECTOMY, REF DYNJ908839A.

Reason

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Sep 30, 2025

Reported

Nov 26, 2025

Distribution

US Nationwide distribution.

Status

Ongoing

Quantity

301 units

Lot / codes

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.

Company location

Northfield, IL

Recall type

Voluntary: Firm initiated

Recall number

Z-0515-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0515-2026 in the FDA Enforcement Report. Also see FDA recall press releases.