Device recall
Z-0515-2026: MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C…
FDA device recall · Class II · Medline Industries, LP
Key facts
| Recall number (Z-number) | Z-0515-2026 |
|---|---|
| Recall event | 97846 |
| 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. |
| Product code | OFG |
| Recalling firm | Medline Industries, LP |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 1417592 |
At a glance
- None Linked 510(k)s
- 10–99 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database