Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ABL800 FLEX model number 393-800 and 393-801 Recalled by Radiometer Medical ApS Due to Through internal investigation is has been determined that...
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 Radiometer Medical ApS directly.
Affected Products
ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004
Quantity: 2 units
Why Was This Recalled?
Through internal investigation is has been determined that an incorrect component was used within the power supply. The incorrect component may cause a short circuit within the power supply resulting in a delay in treatment. The delay could result in a range of risk from cyanosis and low blood pressure to cardiac arrhythmias and severe impairment of cardiac function.
Where Was This Sold?
US: in the state of California
About Radiometer Medical ApS
Radiometer Medical ApS has 25 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report