Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ArjoHuntleigh Flowtron ACS900 Recalled by Arjo, Inc. dba ArjoHuntleigh Due to Reports of the device failure involving delivering continuous...
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 Arjo, Inc. dba ArjoHuntleigh directly.
Affected Products
ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099 Device is used to prevent the occurrence of Deep Vein Thrombosis (DVT) in at-risk patients. The system must be used as part of a prescribed plan of car under the supervision of trained medical and/or Clinical staff. The system is intended for use only in professional healthcare facilities. It is not intended to be used in the home healthcare environment.
Quantity: 40,675 units worldwide
Why Was This Recalled?
Reports of the device failure involving delivering continuous pressure to the calf garment and not deflating as intended, without triggering an alarm.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Arjo, Inc. dba ArjoHuntleigh
Arjo, Inc. dba ArjoHuntleigh has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report