Device recall
Z-2355-2021: HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions…
FDA device recall · Class II · Ethicon Endo-Surgery Inc
Key facts
| Recall number (Z-number) | Z-2355-2021 |
|---|---|
| Recall event | 88434 |
| Product | HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD20 |
| Product code | LFL |
| Recalling firm | Ethicon Endo-Surgery Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K191555 |
| FEI number | 1527736 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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