FDA Medical devices recall ·
MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF recall
- Recall number
- Z-0515-2026
- Date
- (initiated September 30, 2025)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 301 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it 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 you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0515-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.