Haemonetics Corporation

Complete recall history across all FDA and CPSC categories — 31 total recalls

Haemonetics Corporation appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (31)

FDA medical device enforcement actions by Haemonetics Corporation

Date Product Reason Class
Apr 26, 2022 TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034 Due to a shift in the citrated blood reference range for a normal population,... Class II
Apr 19, 2022 Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software ... When the TEG 5000 Analyzer including TEG Analytical Software is used with Pla... Class II
Feb 19, 2020 TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.... Software defect in TEG Manager impacts the displayed alert for out of range t... Class II
Oct 21, 2019 JAPAN LOW VOL(125ML) CS5 SET,LN 261J - Product Usage: its related accessory c... Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Sav... Class II
Oct 21, 2019 JAPAN BASIC HI SPEED CS5 SET,LN 263J - Product Usage: its related accessory c... Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Sav... Class II
Oct 21, 2019 JAPAN CELL SAVER ELITE SET - 125ML - Product Usage: its related accessory com... Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Sav... Class II
Oct 21, 2019 High Speed Cell Saver¿5/5+ Bowl Set Autotransfusion Device - Product Usage: i... Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Sav... Class II
Oct 21, 2019 CS Elite Processing Set (125 ml) Autotransfusion Device - Product Usage:its r... Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Sav... Class II
Oct 21, 2019 CS5/5+ Fastpacks, 125 mL, 150¿ Res Autotransfusion Device - Product Usage: it... Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Sav... Class II
Oct 21, 2019 Japan DISP SET, 263J, 205J, 208 - Product Usage: its related accessory compon... Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Sav... Class II
Oct 21, 2019 JAPAN CS ELITE FASTPACK, 225ML - Product Usage: its related accessory compone... Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Sav... Class II
Oct 21, 2019 CS5/5+ Fastpacks, 225 mL, 150¿ Res Autotransfusion Device - Product Usage: it... Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Sav... Class II
Oct 21, 2019 CS5/5+ Bowl Kit-125 mL Autotransfusion Device - Product Usage: its related ac... Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Sav... Class II
Oct 21, 2019 CS Elite Fastpack, 225 mL, 20¿ Res Autotransfusion Device - Product Usage: it... Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Sav... Class II
Oct 21, 2019 CS Elite Processing Set (225 ml) Autotransfusion Device - Product Usage:its r... Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Sav... Class II
Oct 21, 2019 Japan CS Elite FASTPACK DISP. SET - 125ML - Product Usage: its related access... Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Sav... Class II
Oct 21, 2019 JAPAN DISP SET, 261J, 205J, 208 - Product Usage: its related accessory compon... Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Sav... Class II
Oct 21, 2019 Cell Saver¿5/5+ Bowl Kit (225 ml) Autotransfusion Device - Product Usage: its... Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Sav... Class II
Oct 21, 2019 CS Elite Fastpack, 125 mL, 150 Res Autotransfusion Device - Product Usage: it... Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Sav... Class II
Oct 21, 2019 CS5/5+ Fastpacks, 125 mL, 20¿ Res Autotransfusion Device- Product Usage: its ... Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Sav... Class II
Oct 21, 2019 Japan DISP SET, 263J, 205J, HAR - Product Usage: its related accessory compon... Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Sav... Class II
Oct 21, 2019 CS Elite Fastpack, 225 mL, 150 Res Autotransfusion Device - Product Usage: it... Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Sav... Class II
Oct 21, 2019 JAPAN DISP SET, 261J, 205J, HAR - Product Usage: its related accessory compon... Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Sav... Class II
Oct 21, 2019 CS5/5+ Fastpacks, 225 mL, 20¿ Res Autotransfusion Device - Product Usage: its... Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Sav... Class II
Oct 21, 2019 JAPAN CELL SAVER ELITE SET - 225ML - Product Usage: its related accessory com... Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Sav... Class II
Jul 13, 2018 Haemonetics¿ OrthoPAT¿ System-OPAT QuickConnect Reservoirs. Product Code: OP... OrthoPAT¿ reservoirs are missing the cannula inside the reservoirs. The absen... Class II
Jul 13, 2018 Haemonetics OrthoPAT System-Integrated Set. Product Code: 1150H-00 Ortho... OrthoPAT¿ reservoirs are missing the cannula inside the reservoirs. The absen... Class II
Aug 2, 2017 Cell Saver 5/5+ Bowl Set, 70ml, Product ID: 0291E-00, 0291A-00 Indications... Haemonetics has received isolated reports that in some cases the 70ml centrif... Class II
Aug 2, 2017 Cell Saver Elite Processing Kit, 70 ml, Product ID: CSE-P-70 Indications f... Haemonetics has received isolated reports that in some cases the 70ml centrif... Class II
Jan 26, 2015 Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. ... Specific lots of Level II Control Kits produce high Maximum Amplitude (MA) re... Class II
Jun 20, 2013 TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurp... Research Use Only (RUO) parameters were included in TEG 5000 User Manual. Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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