MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF — Class II medical device recall Z-0627-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-12-11, distributed nationwide. Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil wh
| Recall number | Z-0627-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2024-10-09 |
| Classified | 2024-12-05 |
| Reported by FDA | 2024-12-11 |
| Distributed | Nationwide (US) |
| Quantity | 980 units |
| UPC / GTIN / UDI-DI | 10193489983982, 10195327202934, 10195327286439, 10195327304270, 10195327412487, 10195327515881, 10195327584931, 40193489983983, 40195327202935, 40195327286430, 40195327304271, 40195327412488, 40195327515882, 40195327584932 |
| Lot numbers | 22KMD254, 23ADA376, 23ADB824, 23CMA828, 23DDA319, 23DDA345, 23DDB914, 23EBV384, 23EMK120, 23GMI494, 23HDA481, 23JBW504, 23JMH927, 23KBD038, 23KBG481, 23LBN724, 24CBH515, 24DBF911 |
| Model numbers | DYNJ0160598C, DYNJ0842590G, DYNJ41473G, DYNJ41473I, DYNJ44148G, DYNJ81776A, DYNJ82691 |
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 for recall
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0627-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.