Device recall
Z-1114-2025: Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK…
FDA device recall · Class II · US Endodontics, LLC
Key facts
| Recall number (Z-number) | Z-1114-2025 |
|---|---|
| Recall event | 95776 |
| Product | Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK AP120253PK AP120313PK AP125213PK AP125253PK AP125313PK AP135213PK AP135253PK AP135313PK AP145213PK AP145253PK AP145313PK AP1GP213PK AP1GP253PK AP1GP313PK O.U.S. Products: EdgeFile X7 REF: SX70421MM SX70425MM SX70429MM SX70621MM… |
| Product code | EKS |
| Recalling firm | US Endodontics, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3008857765 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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