Compass Health recalls MediPress pneumatic compression systems Model 6103S-S due to missing FDA premarket clearance. All units are affected. Consumers should contact manufacturer for details.
Product design change did not receive proper premarket clearance and lacks a 510 (k)
Compass Health is recalling all MediPress pneumatic compression systems with model #61:03S-S because they were designed without proper FDA premarket clearance. This could lead to serious health risks if used improperly.
The device lacks proper FDA premarket clearance, meaning it wasn't tested or approved for safety before being sold. This could lead to serious complications if used without the required safety checks.
Healthcare professionals using the MediPress system for patient care are most at risk. Patients receiving treatment with this device may also be affected.
Check for the model number 6103S-S on the device. All units with this model are affected regardless of serial number or lot.
Reach out to Compass Health to confirm your device model and get instructions for next steps.
The official recall notice states the device lacks FDA premarket clearance, so it is not approved for safe use without proper testing.
All MediPress pneumatic compression systems with model number 6103S-S are affected, regardless of serial number or lot.
Contact Compass Health to confirm your device model and get instructions for next steps.
We’ve drafted a message you can send Compass Health to request your refund or repair — edit it as you like.
Subject: Recall Z-1347-2019 — Compass Health Compass Health Hello, I own a Compass Health that is covered by recall Z-1347-2019 from Compass Health. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
