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 pins (P/N 16082) that fit in the left and right leg pivot castings (P/Ns 16049/16056) can rotate and gradually maneuver out of the leg casting after several hundred deployment and folding cycles (designed for easy storage) of the IVEA unit. |
| Product | IVEA Product Part Number 16100 Model 500A |
| Quantity | 570 units |
| Distribution | United States, Australia, Belgium, Canada, China, Germany, Hong Kong, Indonesia, Israel, Netherlands, Singapore, UAE |
| Initiated | 2017-08-24 |
| Classified | 2017-09-29 |
| Terminated | 2019-11-01 |
| Recall number | Z-3239-2017 |
| 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-3239-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/78019/
Alerts for FIREFLY MEDICAL, INC.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.