Device recall
Z-1189-2026: Medline medical procedure convenience kits labeled as: 1) BREAST-HERNIA-PORT…
FDA device recall · Class II · Medline Industries, LP
Key facts
| Recall number (Z-number) | Z-1189-2026 |
|---|---|
| Recall event | 98226 |
| Product | Medline medical procedure convenience kits labeled as: 1) BREAST-HERNIA-PORT CDS-LF, Kit SKU CDS984853L; 2) BREAST BIOPSY PACK, Kit SKU DYNJ45641B; 3) DERMATOLOGY PACK, Kit SKU DYNJT3658A. |
| 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