Fenwal recalls

Fenwal has 10 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 22 Mar 2023. 2 are still ongoing. The most frequent reason is packaging defects.

Total recalls10since 2013

Last 12 months0reported

Class I220% of total

Ongoing2latest 22 Mar 2023

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 2 20%Class II 8 80%Class III 0 0%

Why fenwal is recalled

Product types

By year

2023220%
2021330%
2019440%
2013110%

Ongoing fenwal recalls

2 active

Reported	Class	Recall	Company	Reason	Where
22 Mar 2023Device	CLASS II	Amicus MNC Apheresis Kit Double Needle recalled by Fenwal	Fenwal	Packaging Defects	Nationwide
22 Mar 2023Device	CLASS II	Amicus Exchange Kit Therapeutics recalled by Fenwal	Fenwal	Packaging Defects	Nationwide

All fenwal recalls, newest first

10 total

Reported	Class	Recall	Company	Reason	Where
22 Mar 2023Device	CLASS II	Amicus MNC Apheresis Kit Double Needle recalled by Fenwal	Fenwal	Packaging Defects	Nationwide
22 Mar 2023Device	CLASS II	Amicus Exchange Kit Therapeutics recalled by Fenwal	Fenwal	Packaging Defects	Nationwide
14 Apr 2021Device	CLASS II	Amicus Exchange Kit Therapeutics recalled by Fenwal	Fenwal	Packaging Defects	Nationwide
14 Apr 2021Device	CLASS II	Amicus MNC Apheresis Kit - Double Needle recalled by Fenwal	Fenwal	Packaging Defects	Nationwide
14 Apr 2021Device	CLASS II	Amicus Exchange Kit recalled by Fenwal	Fenwal	Packaging Defects	Nationwide
21 Aug 2019Device	CLASS I	Volumat MC Agilia US, Infusion Pump recalled by Fenwal	Fenwal	Device Malfunction	Nationwide
21 Aug 2019Device	CLASS I	Vigilant Agilia, Vigilant Drug'Lib recalled by Fenwal	Fenwal	Device Malfunction	Nationwide
1 May 2019Device	CLASS II	Fresenius Kabi CATSmart device (Continuous autotransfusion System) recalled	Fenwal	Device Malfunction	Nationwide
3 Apr 2019Device	CLASS II	Vacuum Unit for CATSmart Vacuum Pump recalled by Fenwal	Fenwal	Device Malfunction	Nationwide
19 Jun 2013Device	CLASS II	Amicus Exchange Kit recalled by Fenwal	Fenwal	Labeling Errors	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.