CLASS II Device recall · Reported 22 May 2019 · FDA Enforcement Report
MediPress pneumatic compression system, Half Leg-Segmental Gradient recalled
Compass Health Brands (Corporate Office) is recalling MediPress pneumatic compression system, Half Leg-Segmental Gradient, distributed in 36 states. The recall was initiated on 8 Apr 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1343-2019
- FDA event ID
- 82629
- Recalling firm
- Compass Health Brands (Corporate Office), Middleburg Heights, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Apr 2019
- FDA classified
- 15 May 2019
- Reported
- 22 May 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 8 Apr 2019 | Recall initiated by company | |
| 15 May 2019 | Classified by FDA | +37 days |
| 22 May 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product design change did not receive proper premarket clearance and lacks a 510 (k)
Product as listed by the FDA
MediPress pneumatic compression system, Half Leg-Segmental Gradient, Model #6102-S
Where it was distributed
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
AlabamaArkansasArizonaCaliforniaColoradoFloridaGeorgiaIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMissouriMississippiMontanaNorth Carolina
Questions about this recall
Why was it recalled?
Product design change did not receive proper premarket clearance and lacks a 510 (k)
Which lots are affected?
All Serial Numbers/Lots
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 82629| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | MediPress pneumatic compression system Full Leg recalled | Compass Health Brands (Corporate Office) | Other | 36 states | |
| CLASS II | MediPress pneumatic compression system Full Leg recalled | Compass Health Brands (Corporate Office) | Other | 36 states | |
| CLASS II | MediPress pneumatic compression system Full Leg recalled | Compass Health Brands (Corporate Office) | Other | 36 states | |
| CLASS II | MediPress pneumatic compression system Full Arm recalled | Compass Health Brands (Corporate Office) | Other | 36 states | |
| CLASS II | MediPress pneumatic compression system Full Arm recalled | Compass Health Brands (Corporate Office) | Other | 36 states |
More recalls from Compass Health Brands (Corporate Office)
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | REX (Recovery Exercise X-Trainer) Pressure Therapy System recalled | Compass Health Brands (Corporate Office) | Other | Nationwide |
| Device | CLASS II | Voyager Rollator-intended as a mechanical walker recalled | Compass Health Brands (Corporate Office) | Device Malfunction | Nationwide |
| Device | CLASS II | MediPress pneumatic compression system Full Arm recalled | Compass Health Brands (Corporate Office) | Other | 36 states |
| Device | CLASS II | MediPress pneumatic compression system Full Arm recalled | Compass Health Brands (Corporate Office) | Other | 36 states |
| Device | CLASS II | MediPress pneumatic compression system Full Leg recalled | Compass Health Brands (Corporate Office) | Other | 36 states |
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| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |