Z-0515-2026 Class II Ongoing
FDA device recall Z-0515-2026 was initiated by Medline Industries, LP on Sep 30, 2025 and is designated Class II. Reason for recall: 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 Sa… The recall status is ongoing. Affected quantity: 301 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 26, 2025
- Initiation Date
- Sep 30, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 301 units
Product Description
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 for Recall
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.
Distribution Pattern
US Nationwide distribution.
Code Information
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.