Class II — PEROUSE MEDICAL
| Recalling firm | Perouse Medical |
|---|---|
| Registered facility | Perouse Medical (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Complaints regarding broken blister. |
| Product | DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA- 018SND 0185NA 0185ND; INTERNAL CODE NUMBER: 0185TR- 0185NA- 018SND 0185NA 0185ND |
| Quantity | 18,431 |
| Distribution | US: AZ (shipped through Belgium to USA), MN, TN |
| Initiated | 2017-04-05 |
| Classified | 2017-04-28 |
| Terminated | 2021-02-01 |
| Recall number | Z-1891-2017 |
| 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 — PEROUSE MEDICAL (Z-1891-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77100/
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