livehealth.store

Nuwellis recalls

Nuwellis has 1 recall on record with the FDA and USDA, the earliest in 2025 and the latest reported on 22 Jan 2025. The most frequent reason is device malfunction.

Total recalls1since 2025

Last 12 months0reported

Class I1100% of total

Ongoing0latest 22 Jan 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 1 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 1 100%Class II 0 0%Class III 0 0%

Why nuwellis is recalled

Device Malfunction1100%

Product types

Other Medical Devices1100%

By year

20251100%

All nuwellis recalls, newest first

1 total

Reported	Class	Recall	Company	Reason	Where
22 Jan 2025Device	CLASS I	AquaFlexFlow UF 500 Plus recalled by Nuwellis	Nuwellis	Device Malfunction	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.