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Lympha press leg 2-75 NRC-LEG

MEGO afek Agricultural Cooperative Society Ltd · Model LP 4 2-75 · UDI-DI 07290105876331

JOW Prescription

510(k) clearances

1,705

Adverse events (19 deaths)

Recalls

138

Facilities

Description

The Lympha press leg 2-75 NRC-LEG compression garment fastened around the area to be treated. The garment contains overlapping air chambers. These air chambers are filled with air from the console in sequence, applying a compressive massage. Once the entire area has been compressed, the console releases the pressure, and there is a brief pause. Then the process starts over again, and is repeated until the treatment session is complete.

Recalls

Date	Firm	Reason
2025-05-13	Cardinal Health 200, LLC	Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
2025-05-13	Cardinal Health 200, LLC	Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
2025-05-13	Cardinal Health 200, LLC	Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
2023-04-14	Stryker Sustainability Solutions	Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be mislabeled and/or mispackaged.
2021-07-09	Ortho8, Inc.	EVEXIA LUXE DVT PREVENTION DEVICE is marketed without FDA clearance
2021-07-09	Ortho8, Inc.	CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance
2019-04-08	Compass Health Brands (Corporate Office)	Product design change did not receive proper premarket clearance and lacks a 510 (k)
2019-04-08	Compass Health Brands (Corporate Office)	Product design change did not receive proper premarket clearance and lacks a 510 (k)
2019-04-08	Compass Health Brands (Corporate Office)	Product design change did not receive proper premarket clearance and lacks a 510 (k)
2019-04-08	Compass Health Brands (Corporate Office)	Product design change did not receive proper premarket clearance and lacks a 510 (k)

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.