Recall
Class II — Abbott
| Recalling firm | ABBOTT LABORATORIES |
|---|---|
| Registered facility | View this company's 64 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Instructions for use were updated. |
| Product | Amplatzer Steerable Delivery Sheath |
| Quantity | 529 units |
| Distribution | OUS distribution only |
| Initiated | 2021-11-09 |
| Classified | 2022-04-07 |
| Terminated | 2024-08-07 |
| Recall number | Z-0895-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Abbott (Z-0895-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89714/
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