Recall Register

Food, drugs, devices › Firms

Haemonetics Corporation

FDA recalling firm · 8 enforcement events · 31 product records · 2013–2022 · MA

Haemonetics Corporation has 8 FDA enforcement events on this register (31 product records) between 2013 and 2022: 8 device; the busiest year was 2022 with 2.

0% of its events are Class I; the most common class is Class II (8). 0 events are listed as ongoing; the recalling firm's address is in MA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
26 Apr 2022TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034DeviceClass II1Terminated
19 Apr 2022Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping Assay - PlateletMapping ADP & AA (07-014), PlateletMapping ADP (07-015), PlateletMapping AA (07-016). Issue occurs when Platelet Mapping Assay results from a TEG 5000 analyzer are viewed using TEG…DeviceClass II1Terminated
19 Feb 2020TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0 and 4.1.1. Intended: For in vitro coagulation studiesDeviceClass II1Terminated
21 Oct 2019CS5/5+ Fastpacks, 225 mL, 150¿ Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.DeviceClass II22Terminated
13 Jul 2018Haemonetics OrthoPAT System-Integrated Set. Product Code: 1150H-00 OrthoPAT orthopedic perioperative autotransfusion system indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during surgical proceduresDeviceClass II2Terminated
2 Aug 2017Cell Saver 5/5+ Bowl Set, 70ml, Product ID: 0291E-00, 0291A-00 Indications for Use: The Haemonetics Cell Saver 5/5+ System and its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.DeviceClass II2Terminated
26 Jan 2015Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. Level II Control is a biological control for use with the Thrombelastograph (TEG) Hemostasis System.DeviceClass II1Terminated
20 Jun 2013TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation StudiesDeviceClass II1Terminated

By type and class

Device8
Class II8

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

13
15
17
19
21
23
25
Enforcement events for Haemonetics Corporation by year initiated.

Questions and answers

How many FDA recalls has Haemonetics Corporation had?

8 enforcement events (31 product records) on this register, 2013–2022: 8 device.

Are any Haemonetics Corporation recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Haemonetics Corporation recalls?

8 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.