Browse Device Recalls

31 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 31 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 31 FDA device recalls.

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DateProductReasonClassFirm
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, the ranges stated i... Class II Haemonetics Corporation
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 PlateletMapping (ADP or... Class II Haemonetics Corporation
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 test results. Due to ... Class II Haemonetics Corporation
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 Saver¿ Elite¿/Elite¿ +1... Class II Haemonetics Corporation
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 Saver¿ Elite¿/Elite¿ +1... Class II Haemonetics Corporation
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 Saver¿ Elite¿/Elite¿ +1... Class II Haemonetics Corporation
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 Saver¿ Elite¿/Elite¿ +1... Class II Haemonetics Corporation
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 Saver¿ Elite¿/Elite¿ +1... Class II Haemonetics Corporation
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 Saver¿ Elite¿/Elite¿ +1... Class II Haemonetics Corporation
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 Saver¿ Elite¿/Elite¿ +1... Class II Haemonetics Corporation
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 Saver¿ Elite¿/Elite¿ +1... Class II Haemonetics Corporation
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 Saver¿ Elite¿/Elite¿ +1... Class II Haemonetics Corporation
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 Saver¿ Elite¿/Elite¿ +1... Class II Haemonetics Corporation
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 Saver¿ Elite¿/Elite¿ +1... Class II Haemonetics Corporation
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 Saver¿ Elite¿/Elite¿ +1... Class II Haemonetics Corporation
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 Saver¿ Elite¿/Elite¿ +1... Class II Haemonetics Corporation
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 Saver¿ Elite¿/Elite¿ +1... Class II Haemonetics Corporation
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 Saver¿ Elite¿/Elite¿ +1... Class II Haemonetics Corporation
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 Saver¿ Elite¿/Elite¿ +1... Class II Haemonetics Corporation
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 Saver¿ Elite¿/Elite¿ +1... Class II Haemonetics Corporation
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 Saver¿ Elite¿/Elite¿ +1... Class II Haemonetics Corporation
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 Saver¿ Elite¿/Elite¿ +1... Class II Haemonetics Corporation
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 Saver¿ Elite¿/Elite¿ +1... Class II Haemonetics Corporation
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 Saver¿ Elite¿/Elite¿ +1... Class II Haemonetics Corporation
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 Saver¿ Elite¿/Elite¿ +1... Class II Haemonetics Corporation
Jul 13, 2018 Haemonetics¿ OrthoPAT¿ System-OPAT QuickConnect Reservoirs. Product Code: OP... OrthoPAT¿ reservoirs are missing the cannula inside the reservoirs. The absence of this cannula p... Class II Haemonetics Corporation
Jul 13, 2018 Haemonetics OrthoPAT System-Integrated Set. Product Code: 1150H-00 Ortho... OrthoPAT¿ reservoirs are missing the cannula inside the reservoirs. The absence of this cannula p... Class II Haemonetics Corporation
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 centrifuge bowl may leak du... Class II Haemonetics Corporation
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 centrifuge bowl may leak du... Class II Haemonetics Corporation
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) results, which are out... Class II Haemonetics Corporation
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 Haemonetics Corporation

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.