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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.