IVEA 500A Intended for Med-Surg patient care — Class II medical device recall Z-0767-2017
Terminated recall by Firefly Medical, Inc., reported 2016-12-21. The dowel pin could potentially slip out of its press fit, resulting in the product potentially slumping to on
| Recall number | Z-0767-2017 |
|---|---|
| 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 | 2016-11-01 |
| Classified | 2016-12-15 |
| Reported by FDA | 2016-12-21 |
| Terminated | 2017-08-01 |
| Countries outside the US | CA |
| Quantity | 239 |
| Serial numbers | 100200-101068 |
| Model numbers | 16100 |
Product
IVEA 500A Intended for Med-Surg patient care.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0767-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.