Firefly Medical Recalls IVEA Product Part Number 16100 Model 500A
Firefly Medical is recalling 570 IVEA units because dowel pins can rotate and dislodge from leg castings after repeated use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the defect presents a risk of harm (mechanical failure of leg supports) without reported injuries, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Firefly Medical, Inc. is recalling 570 units of the IVEA Product Part Number 16100 Model 500A. The recall involves specific serial numbers listed in the agency's official record.
The recall was initiated because 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. This issue can occur after several hundred deployment and folding cycles of the IVEA unit, which are designed for easy storage.
The affected units were distributed in the United States, Australia, Belgium, Canada, China, Germany, Hong Kong, Indonesia, Israel, Netherlands, Singapore, and UAE. Consumers and healthcare providers should check their serial numbers against the list provided by the FDA and contact Firefly Medical for instructions on how to proceed.
The recalled product
- Product
- IVEA Product Part Number 16100 Model 500A
- Manufacturer
- Firefly Medical, Inc.
- Category
- Medical Device — Mobility Aid
- Affected units
- 570
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial Numbers - 100201
- 100251
- 100297
- 100343
- 100390
- 100438
- 100487
- 100666
- 100586
- 100202
- 100252
- 100298
- 100344
- 100391
- 100439
- 100488
- 100667
- 100587
- 100204
- 100253
Distribution
Distribution scope not specified by the agency.
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