Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
IVEA Product Part Number 16100 Model 500A Recalled by Firefly Medical, Inc. Due to The dowel pins (P/N 16082) that fit in...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Firefly Medical, Inc. directly.
Affected Products
IVEA Product Part Number 16100 Model 500A
Quantity: 570 units
Why Was This Recalled?
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.
Where Was This Sold?
United States, Australia, Belgium, Canada, China, Germany, Hong Kong, Indonesia, Israel, Netherlands, Singapore, UAE
About Firefly Medical, Inc.
Firefly Medical, Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report