Compass Health MediPress Half Leg-Segmental Gradient Model 6102-S Recall: Missing 510(k)
Compass Health recalls MediPress pneumatic compression systems with model #6102-S due to missing premarket clearance. Affected units may not be safe for medical use without regulatory approval.
Recall notice
Product design change did not receive proper premarket clearance and lacks a 510 (k)
Contact the company
What happened, in plain English
Compass Health is recalling MediPress pneumatic compression systems with model #610: Half Leg-Segmental Gradient, serial numbers/lots. This recall happens because the product design change didn't get proper premarket regulatory approval, which could mean it's unsafe for medical use. Read more at govinfonow.com/recall/68393-compass-health-medipress-half-leg-segmental-gradient-model-6102-s.
Source Summary by GovInfoNow · govinfonow.com/recall/68393-compass-health-medipress-half-leg-segmental-gradient-model-6102-s · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1343-2019
Cite this page
“Compass Health MediPress Half Leg-Segmental Gradient Model 6102-S Recall: Missing 510(k).” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68393-compass-health-medipress-half-leg-segmental-gradient-model-6102-s. Based on FDA recall #Z-1343-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1343-2019%22&limit=1).
Why it’s dangerous
The product design change did not receive proper premarket clearance, meaning it might not meet safety standards. Without regulatory approval (510(k)), the device could pose risks during medical use.
Who’s affected
Medical facilities using the MediPress system with model #6102-S are likely affected. Patients receiving treatment with this device could be at risk if it's not properly cleared by regulators.
How to tell if you have this one
Check for the model number 6102-S on the MediPress system. All serial numbers and lots are affected by this recall. The product is a half leg-segmental gradient pneumatic compression system.
- Brand
Compass Health- Category
Medical device
All 6 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- 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
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1343-2019 | MediPress pneumatic compression system, Half Leg-Segmental Gradient, Model #6102-S; All Serial Numbers/Lots | — |
| Z-1344-2019 | MediPress pneumatic compression system Full Leg (Medium)-Segmental Gradient, Model #6103M-S; All Serial Numbers/Lots | — |
| Z-1345-2019 | MediPress pneumatic compression system Full Arm (Medium)-Segmental Gradient, Model #6104M-S; All Serial Numbers/Lots | — |
| Z-1346-2019 | MediPress pneumatic compression system Full Leg (Long)-Segmental Gradient, Model #6103L-S; All Serial Numbers/Lots | — |
| Z-1347-2019 | MediPress pneumatic compression system Full Leg (Short)-Segmental Gradient, Model #6103S-S; All Serial Numbers/Lots | — |
| Z-1348-2019 | MediPress pneumatic compression system Full Arm (Short)-Segmental Gradient, Model #6104S-S; All Serial Numbers/Lots | — |
What to do — step by step
Check Device Model
Identify the model number on the MediPress system to confirm if it's 6102-S.
Where it went and when
Where it was distributed
Distributed in 36 states, and outside the U.S.
FDA 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” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Arizona, Arkansas, California, Colorado, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, Wyoming.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is there a risk of injury from this device?
The recall record does not describe specific injury risks, so the danger level is unknown.
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Where this comes from
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.
- Official source: FDA Recall #Z-1343-2019 (April 8, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1343-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.