Firefly Medical recalls IVEA Model 500A: Dowel pins may rotate out of leg castings
Firefly Medical recalls IVEA Model 500A (serial numbers listed) due to dowel pins that can rotate out of leg castings after repeated use, potentially causing instability.
Lower-risk 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.
Contact the company
What happened, in plain English
Firefly Medical is recalling IVEA Model 500A devices with specific serial numbers because the dowel pins that hold the legs can gradually rotate out of their castings after many uses. This could cause the device to become unstable during use. Read more at govinfonow.com/recall/73119-firefly-medical-recalls-ivea-model-500a-dowel-pins-may-rotate.
Source Summary by GovInfoNow · govinfonow.com/recall/73119-firefly-medical-recalls-ivea-model-500a-dowel-pins-may-rotate · Updated September 18, 2026 · FDA enforcement record: FDA #Z-3239-2017
Cite this page
“Firefly Medical recalls IVEA Model 500A: Dowel pins may rotate out of leg castings.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73119-firefly-medical-recalls-ivea-model-500a-dowel-pins-may-rotate. Based on FDA recall #Z-3239-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3239-2017%22&limit=1).
Why it’s dangerous
The dowel pins that fit into the left and right leg pivot castings can rotate and gradually move out of their intended positions after several hundred deployment and folding cycles. This may cause the device to become unstable during use, but it does not pose an immediate risk of injury.
Who’s affected
Users of the IVEA Model 500A with the listed serial numbers are affected. People who use this device for medical purposes are most at risk if the device becomes unstable.
How to tell if you have this one
Check your IVEA Model 500A device for serial numbers listed in the recall notice. The product has a specific part number (16100) and the affected units have the serial numbers provided in the recall list.
- Brand
Firefly Medical- Category
Medical device
What to do — step by step
Check Device Serial
Look for the serial number on your IVEA Model 500A device to see if it matches the list of affected units provided in the recall.
How this recall unfolded
Recall timeline
FDA terminated this recall 2.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-3239-2017 (August 24, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3239-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.