FDA Medical Device Recalls (openFDA)
Compass Health Brands (Corporate Office): MediPress pneumatic compression system Full Arm (Medium)-Segmental Gradient, Model #6104M-S
- Recall number
- Z-1345-2019
- Recalling firm
- Compass Health Brands (Corporate Office)
- Product
- MediPress pneumatic compression system Full Arm (Medium)-Segmental Gradient, Model #6104M-S
- Status
- Terminated
- Initiated
- 2019-04-08
- Posted
- not on file
- Terminated
- 2020-10-26
- Reason
- Product design change did not receive proper premarket clearance and lacks a 510 (k)
- Root cause
- Device Design
- Action
- On April 8, 2019 Compass Health issued URGENT MEDICAL DEVICE RECALL notices and Response Forms to customers via courier service. Customers were advised to take the following actions: 1) Ensure all affected personnel are fully informed of this notice. Forward the notice to the Regulatory Compliance Manager, Purchasing Manager, Customer Service Manager and Field Technicians. 2) Advise impacted customers regarding this recall. 3) Immediately check your stock for the model numbers and quarantine all affected product 4) Complete and return the Recall Response Form within fifteen (15) days of receipt of the notice via email to recall@compasshealthbrands.com or via fax to 440-268-2116. Customer with questions may call Compass Health Brands Corp. Customer Support at (800) 376-7263 Monday-Friday 8:00 am EST 5:00 pm EST.
- Quantity
- not on file
- Distribution
- Domestically to AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TN, KY, TX, UT, VA, WA, WI & WY Internationally to Canada
- Lot, serial or model codes
- All Serial Numbers/Lots
- 510(k) numbers
- ["K974393"]
- PMA numbers
- not on file
- Product code
- JOW
- Firm FEI
- 3012316249
- Firm city
- Middleburg Heights
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28