FDA Device recall Z-0627-2025
MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C
- FDA Device
- Class II
- ongoing
- Published 2024-12-11
On 2024-12-11 the FDA classified a Class II recall of MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C by Medline Industries Northfield, citing medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0627-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-09 |
| Published | 2024-12-11 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BREAST BIOPSY PACK-LF, REF DYNJ0842590G; 3) TREATMENT ROOM PACK, REF DYNJ41473G; 4) TREATMENT ROOM PACK, REF DYNJ41473I; 5) BREAST BIOPSY PACK, REF DYNJ44148G; 6) PRX BREAST PACK, REF DYNJ81776A; 7) TAMPONADE, REF DYNJ82691
Reason
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Identifiers
| code_info | 1) REF DYNJ0160598C, UDI/DI 10195327304270 (each) 40195327304271 (case), Lot Numbers: 23ADA376, 23DDA345, 23ADB824;…1) REF DYNJ0160598C, UDI/DI 10195327304270 (each) 40195327304271 (case), Lot Numbers: 23ADA376, 23DDA345, 23ADB824; 2) REF DYNJ0842590G, UDI/DI 10195327286439 (each) 40195327286430 (case), Lot Numbers: 23HDA481, 23DDB914, 23DDA319; 3) REF DYNJ41473G, UDI/DI 10193489983982 (each) 40193489983983 (case), Lot Numbers: 22KMD254, 23KBD038, 23EMK120, 23CMA828; 4) REF DYNJ41473I, UDI/DI 10195327584931 (each) 40195327584932 (case), Lot Numbers: 24DBF911; 5) REF DYNJ44148G, UDI/DI 10195327412487 (each) 40195327412488 (case), Lot Numbers: 23EBV384, 23JBW504, 23KBG481; 6) REF DYNJ81776A, UDI/DI 10195327515881 (each) 40195327515882 (case), Lot Numbers: 23LBN724, 24CBH515; 7) REF DYNJ82691, UDI/DI 10195327202934 (each) 40195327202935 (case), Lot Numbers: 23GMI494, 23JMH927 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Medline Industries Northfield
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All Medline Industries Northfield recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0627-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.