Browse Device Recalls

204 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 204 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 204 FDA device recalls.

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DateProductReasonClassFirm
May 28, 2025 CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Ca... Due to an error in assembly of the thermistor within some units, the affected probes will experie... Class II Terumo Cardiovascular Systems Corporation
Mar 3, 2025 Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Ca... During some clinical cases, it has been observed that the SO2 value may periodically appear as d... Class II Terumo Cardiovascular Systems Corporation
Feb 20, 2024 Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A ... Pressure relief valve included in certain lots of cardiovascular procedure kits was reportedly op... Class II Terumo Cardiovascular Systems Corporation
Mar 1, 2023 CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30 Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improp... Class II Terumo Cardiovascular Systems Corporation
Mar 1, 2023 CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improp... Class II Terumo Cardiovascular Systems Corporation
Mar 1, 2023 CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improp... Class II Terumo Cardiovascular Systems Corporation
Jun 8, 2021 Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #... intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calib... Class II Terumo Cardiovascular Systems Corporation
Apr 16, 2021 The Terumo HX2 Temperature Management System provides temperature control of ... Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns... Class II Terumo Cardiovascular Systems Corporation
Apr 16, 2021 The Sarns Temperature Control and Monitor unit (TCM) is a source of temperatu... Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns... Class II Terumo Cardiovascular Systems Corporation
Apr 16, 2021 The Sarns TCM II (system) is a source of temperature-controlled water for blo... Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns... Class II Terumo Cardiovascular Systems Corporation
Mar 2, 2021 Consist of a distal connection mechanism (either standard Terumo Ball Quick C... There is a potential for the stainless steel locking plates on the device's sternal retractor loc... Class II Terumo Cardiovascular Systems Corporation
Nov 11, 2020 (1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir,... Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. West) Class II Terumo Cardiovascular Systems Corporation
Aug 25, 2020 Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Ca... Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble dete... Class II Terumo Cardiovascular Systems Corporation
Aug 25, 2020 Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Nu... Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble dete... Class II Terumo Cardiovascular Systems Corporation
Aug 25, 2020 Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Nu... Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble dete... Class II Terumo Cardiovascular Systems Corporation
Jan 10, 2020 Terumo Advanced Perfusion System 1 Roller Pump, 6 Inch, Catalog Number 816571... These roller pumps were assembled with pump shafts that may fail at the location of the thread wh... Class II Terumo Cardiovascular Systems Corporation
Jan 10, 2020 Terumo Advanced Perfusion Assembly Pump Guts, 6 Inch, Catalog Number 801798 -... These roller pumps were assembled with pump shafts that may fail at the location of the thread wh... Class II Terumo Cardiovascular Systems Corporation
Jan 10, 2020 Terumo Advanced Perfusion System 1 Roller Pump, 4 Inch, Catalog Number 816570... These roller pumps were assembled with pump shafts that may fail at the location of the thread wh... Class II Terumo Cardiovascular Systems Corporation
Jan 10, 2020 Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 -... These roller pumps were assembled with pump shafts that may fail at the location of the thread wh... Class II Terumo Cardiovascular Systems Corporation
Jun 14, 2019 Terumo Capiox NX19 Oxygenator (East Orientation), P/N: CXOT280 Exported only... Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component Class II Terumo Cardiovascular Systems Corporation
Jun 14, 2019 Terumo Capiox NX19 Oxygenator With Reservoir (West Orientation) P/N: 3CX*NX19RW Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component Class II Terumo Cardiovascular Systems Corporation
Jun 14, 2019 Terumo Capiox NX19 Oxygenator (West Orientation P/N:CXOT281 Exported only to... Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component Class II Terumo Cardiovascular Systems Corporation
Jun 14, 2019 Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component Class II Terumo Cardiovascular Systems Corporation
Apr 18, 2019 Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 8... The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter. Class II Terumo Cardiovascular Systems Corporation
Dec 20, 2018 Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222 Presence of natural rubber latex is not declared in the label Class II Terumo Cardiovascular Systems Corporation
Oct 17, 2018 Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Elec... An intermittent failure which causes a blender initialization fault upon start-up or during an EP... Class II Terumo Cardiovascular Systems Corporation
Sep 13, 2018 Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#:... The service manual was not updated at the time of the release of software version 1.30. Class II Terumo Cardiovascular Systems Corporation
Aug 31, 2018 VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX... The system's IFU contains a list of generators that the have been deemed compatible. Recent repo... Class II Terumo Cardiovascular Systems Corporation
Aug 28, 2018 Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardi... Screws on a Terumo¿ Advanced Perfusion System 1 Power Manager Board (the base unit circuit board... Class II Terumo Cardiovascular Systems Corporation
Aug 28, 2018 Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardi... Screws on a Terumo¿ Advanced Perfusion System 1 Power Manager Board (the base unit circuit board... Class II Terumo Cardiovascular Systems Corporation
Jun 26, 2018 Monitor with one Blood Parameter Module and one HSat Probe; 500AHCT Monitor ... H/Sat Hybrid Intensity Shift has been seen in a subset of the H/Sat population, which has resulte... Class II Terumo Cardiovascular Systems Corporation
Jun 26, 2018 CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 Product U... H/Sat Hybrid Intensity Shift has been seen in a subset of the H/Sat population, which has resulte... Class II Terumo Cardiovascular Systems Corporation
Mar 16, 2018 Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX... Update to cooler-heater cleaning instructions. Class II Terumo Cardiovascular Systems Corporation
Mar 16, 2018 Sarns TCM, Catalog No. 15747 The Sarns TCM is indicated for controlling ... Update to cooler-heater cleaning instructions. Class II Terumo Cardiovascular Systems Corporation
Mar 16, 2018 Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI 00... Update to cooler-heater cleaning instructions. Class II Terumo Cardiovascular Systems Corporation
Jan 19, 2018 Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provi... Inaccurrate flow readings. Depending on the degree of inaccuracy, this issue may not be easy for... Class II Terumo Cardiovascular Systems Corporation
Jun 27, 2017 Custom surgical kits containing TERUMO(R) Overpressure Safety Valve, REF: (a)... Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-press... Class II Terumo Cardiovascular Systems Corporation
Jun 27, 2017 TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-press... Class II Terumo Cardiovascular Systems Corporation
Feb 20, 2017 Terumo Advanced Perfusion System 1-Level Sensor II Pads, Product Usage: ... Terumo CVS initiated a voluntary recall for the Level Sensor II Pads and Level Sensor Gel Pads du... Class II Terumo Cardiovascular Systems Corporation
Feb 20, 2017 Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads Product Usage:... Terumo CVS initiated a voluntary recall for the Level Sensor II Pads and Level Sensor Gel Pads du... Class II Terumo Cardiovascular Systems Corporation
Jun 8, 2016 Sarns TCM II; The Sarns Temperature Control and Monitor unit (TCM) II (sy... Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler ... Class II Terumo Cardiovascular Systems Corporation
Jun 8, 2016 HX2" Temperature Management Systems; The Terumo¿ HX2" Temperature Managem... Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler ... Class II Terumo Cardiovascular Systems Corporation
Jun 8, 2016 Preamendments device-Sarns Dual Cooler-Heater. The Sarns Dual Cooler-He... Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler ... Class II Terumo Cardiovascular Systems Corporation
Jun 8, 2016 Sarns TCM; The Sarns Temperature Control and Monitor unit (TCM) is a sour... Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler ... Class II Terumo Cardiovascular Systems Corporation
Mar 14, 2016 CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blo... Specific CDI¿ Blood Parameter Monitoring System 500 devices are being voluntarily recalled becaus... Class II Terumo Cardiovascular Systems Corporation
Dec 11, 2015 CDI¿ H/S Cuvette The intended use for the CDI¿ H IS Cuvette is as follows:... Terumo Cardiovascular Systems (Terumo CVS) has received complaints of the CDI System 500 monitor ... Class III Terumo Cardiovascular Systems Corporation
Aug 7, 2015 CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line moni... Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a ... Class II Terumo Cardiovascular Systems Corporation
May 27, 2015 The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxi... Terumo Cardiovascular Systems Corporation has received complaints indicating that the Sarns Centr... Class II Terumo Cardiovascular Systems Corporation
May 1, 2015 100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Pe... Terumo CVS is implementing field correction activities to address the identified causes of the Te... Class II Terumo Cardiovascular Systems Corporation
May 1, 2015 Base for Terumo Advanced Perfusion System 1, 220/240V The Terumo¿ Advanced Pe... Terumo CVS is implementing field correction activities to address the identified causes of the Te... Class II Terumo Cardiovascular Systems 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.