Device recall
Z-1809-2025: Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK…
FDA device recall · Class I · MEDLINE INDUSTRIES, LP - Northfield
Key facts
| Recall number (Z-number) | Z-1809-2025 |
|---|---|
| Recall event | 96821 |
| Product | Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ30926O 2. CRANIOTOMY, SKU CDS983611N 3. CRANIOTOMY CDS, SKU CDS983467J 4. CRANIOTOMY PACK, SKU DYNJ85807A, DYNJ85927 5. MAJOR CRANIOTOMY PACK, SKU DYNJ82007A |
| Product code | LRO |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K213481 |
| FEI number | 1417592 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1,000+ 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