Device recall
Z-0794-2025: Medline custom medical procedure kits labeled as: 1) CRANI, REF CDS780089V; 2)…
FDA device recall · Class II · MEDLINE INDUSTRIES, LP - Northfield
Key facts
| Recall number (Z-number) | Z-0794-2025 |
|---|---|
| Recall event | 95852 |
| Product | Medline custom medical procedure kits labeled as: 1) CRANI, REF CDS780089V; 2) CRANIOFACIAL CDS, REF CDS780102K; 3) CRANIOFACIAL CDS, REF CDS780102L; 4) CRANIOFACIAL CDS, REF CDS780102M; 5) CRANIOTOMY CDS-LF, REF CDS780105K; 6) CRANIOTOMY CDS-LF, REF CDS780105L; 7) CRANIOTOMY CDS-LF, REF CDS780105M… |
| Product code | OJH |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield |
| 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
- 100–999 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