Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Arthex S3 Arm Sleeve Connector Recalled by Allen Medical Systems, Inc. Due to During use, the unit could separate un-expectantly. This...
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 Allen Medical Systems, Inc. directly.
Affected Products
Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and distributed between March and November 2016.
Quantity: 420 devices
Why Was This Recalled?
During use, the unit could separate un-expectantly. This failure would allow the patient's arm to fall out of suspension during a procedure, possibly causing moderate injury to the patient. This potential defect is not apparent to the user.
Where Was This Sold?
This product was distributed to 1 state: FL
About Allen Medical Systems, Inc.
Allen Medical Systems, Inc. has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report