Class II — Firefly Medical, Inc.
| Recalling firm | FIREFLY MEDICAL, INC. |
|---|---|
| Registered facility | FIREFLY MEDICAL, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The dowel pin could potentially slip out of its press fit, resulting in the product potentially slumping to one side which could cause the patient to stumble. |
| Product | IVEA 500A Intended for Med-Surg patient care. |
| Quantity | 239 |
| Distribution | Worldwide Distribution -- USA and Canada. |
| Initiated | 2016-11-01 |
| Classified | 2016-12-15 |
| Terminated | 2017-08-01 |
| Recall number | Z-0767-2017 |
| 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 — Firefly Medical, Inc. (Z-0767-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75571/
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