IVEA Product Part Number 16100 Model 500A — Class II medical device recall Z-3239-2017
Terminated recall by Firefly Medical, Inc., reported 2017-10-11. The dowel pins (P/N 16082) that fit in the left and right leg pivot castings (P/Ns 16049/16056) can rotate and
| Recall number | Z-3239-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Firefly Medical, Inc., Fort Collins, CO, United States |
| Recall initiated | 2017-08-24 |
| Classified | 2017-09-29 |
| Reported by FDA | 2017-10-11 |
| Terminated | 2019-11-01 |
| Countries outside the US | AE, AU, BE, CA, CN, DE, HK, ID, IL, NL, SG |
| Quantity | 570 units |
| Serial numbers | 100201, 100202, 100204, 100205, 100206, 100207, 100208, 100209, 100210, 100211, 100212, 100213, 100214, 100215, 100216, 100217, 100218, 100219, 100221, 100222, 100223, 100224, 100225, 100226, 100227 and 475 more |
| Model numbers | 16100, 500A |
Product
IVEA Product Part Number 16100 Model 500A
Reason for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.