Haemonetics recalls

Haemonetics has 31 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 6 Jul 2022. The most frequent reason is packaging defects.

Total recalls31since 2013

Last 12 months0reported

Class I00% of total

Ongoing0latest 6 Jul 2022

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 0 0%Class II 31 100%Class III 0 0%

Why haemonetics is recalled

Product types

By year

202226%
20202374%
201926%
201826%
201513%
201313%

All haemonetics recalls, newest first

31 total

Reported	Class	Recall	Company	Reason	Where
6 Jul 2022Device	CLASS II	TEG5000 Analyzer (07-022, 07-033) with TEG Analytical recalled	Haemonetics	Potency & Assay	Nationwide
6 Jul 2022Device	CLASS II	TEG 5000 Functional Fibrinogen Reagent recalled by Haemonetics	Haemonetics	Lead & Heavy Metals	Nationwide
8 Apr 2020Device	CLASS II	TEG Manager recalled by Haemonetics	Haemonetics	Lead & Heavy Metals	Nationwide
5 Feb 2020Device	CLASS II	Japan Low Vol Cs5 Set,ln 261j recalled by Haemonetics	Haemonetics	Packaging Defects	Nationwide
5 Feb 2020Device	CLASS II	Japan Basic Hi Speed Cs5 Set,ln 263j recalled by Haemonetics	Haemonetics	Packaging Defects	Nationwide
5 Feb 2020Device	CLASS II	Japan Cell Saver Elite Set recalled by Haemonetics	Haemonetics	Packaging Defects	Nationwide
5 Feb 2020Device	CLASS II	High Speed Cell Saver¿5/5+ Bowl Set Autotransfusion Device recalled	Haemonetics	Packaging Defects	Nationwide
5 Feb 2020Device	CLASS II	CS Elite Processing Set Autotransfusion Device recalled by Haemonetics	Haemonetics	Packaging Defects	Nationwide
5 Feb 2020Device	CLASS II	CS5/5+ Fastpacks, 150¿ Res Autotransfusion Device recalled	Haemonetics	Packaging Defects	Nationwide
5 Feb 2020Device	CLASS II	Japan DISP SET, 263J, 205J recalled by Haemonetics	Haemonetics	Packaging Defects	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.