FDA Device Intelligence
HomeDevice types › JOW

Sleeve, Limb, Compressible

FDA product code JOW · Class 2 · Cardiovascular

2,563
Registered devices
1,705
Adverse events
32
Recalls
352
510(k) clearances

Devices with this code

Recent recalls

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

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.