Browse Device Recalls

780 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 780 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 780 FDA device recalls.

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DateProductReasonClassFirm
Jul 15, 2020 StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product... The product contains a non-functional component not referenced in product labeling. Class II Stimwave Technologies Inc
Jul 15, 2020 StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and... The product contains a non-functional component not referenced in product labeling. Class II Stimwave Technologies Inc
Jul 15, 2020 StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.... The product contains a non-functional component not referenced in product labeling. Class II Stimwave Technologies Inc
Jul 15, 2020 StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and... The product contains a non-functional component not referenced in product labeling. Class II Stimwave Technologies Inc
Jul 15, 2020 StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - Product... The product contains a non-functional component not referenced in product labeling. Class II Stimwave Technologies Inc
Jul 15, 2020 StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US - Produc... The product contains a non-functional component not referenced in product labeling. Class II Stimwave Technologies Inc
Jul 14, 2020 Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cio... Hardware error- Hot Plugging feature could cause an electrical malfunction on the main control D... Class II Siemens Medical Solutions USA, Inc
Jul 6, 2020 Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flex... BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... Class II Boston Scientific Corporation
Jul 6, 2020 Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flex... BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... Class II Boston Scientific Corporation
Jul 6, 2020 Captiflex Snares, Single-Use Polypectomy Snare consists of a flexible wire ca... BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... Class II Boston Scientific Corporation
Jul 6, 2020 Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flex... BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... Class II Boston Scientific Corporation
Jul 6, 2020 Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flex... BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... Class II Boston Scientific Corporation
Jul 6, 2020 Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flex... BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... Class II Boston Scientific Corporation
Jul 6, 2020 Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flex... BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... Class II Boston Scientific Corporation
Jun 22, 2020 CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usa... Software defect may result in disapperance of tag sites during recalculation and lead to addition... Class II Biosense Webster (israel), Ltd.
Jun 18, 2020 Phillips Charging Station, Product #: 989803191021 - Product Usage: This char... A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its a... Class II Philips North America, LLC
Jun 18, 2020 Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 - Prod... A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its a... Class II Philips North America, LLC
Jun 18, 2020 Phillips Module Charger, Product #: 989803191031 - Product Usage: This Module... A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its a... Class II Philips North America, LLC
Jun 17, 2020 FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to... An electrical sub-circuit was not properly connected. Its purpose is to eliminate the possibility... Class II FHC, Inc.
Jun 8, 2020 Accurian RF Ablation, Cannula pk, Accurian, 100mm, 18G, 10mm, CS Product Numb... Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. Class II Medtronic Sofamor Danek USA Inc
Jun 8, 2020 Accurian RF Ablation, Cannula pk, Accurian, 150mm, 18G, 10mm, CS Product Numb... Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. Class II Medtronic Sofamor Danek USA Inc
Jun 8, 2020 Accurian RF Ablation, Cannula pk, Accurian, 100mm, 20G, 10mm, CS Product Numb... Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. Class II Medtronic Sofamor Danek USA Inc
Jun 8, 2020 Accurian RF Ablation,Cannula pk, Accurian, 100mm, 22G, 10mm, SS Product Numbe... Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. Class II Medtronic Sofamor Danek USA Inc
Jun 8, 2020 Accurian RF Ablation, Cannula pk, Accurian, 100mm, 22G, 5mm, CS Product Numbe... Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. Class II Medtronic Sofamor Danek USA Inc
Jun 8, 2020 Accurian RF Ablation, Cannula pk, Accurian, 150mm, 20G, 10mm, CS Product Numb... Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. Class II Medtronic Sofamor Danek USA Inc
Apr 30, 2020 Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-... Artis systems containing a Multi Display Manager of a specific lot, the power distributor may lea... Class II Siemens Medical Solutions USA, Inc
Apr 20, 2020 Siemens Cios Spin VA30-mobile X-Ray system, Material # 10308194 - Product Us... Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-a... Class II Siemens Medical Solutions USA, Inc
Apr 20, 2020 Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an... Internal Paddles may wear over time and may not be safe or ready for use, unless the directions i... Class II Philips North America, LLC
Apr 20, 2020 Siemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 The Cios Al... Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-a... Class II Siemens Medical Solutions USA, Inc
Apr 20, 2020 Siemens Cios Alpha VA30-mobile X-Ray system, Material # 11105200 The Cios A... Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-a... Class II Siemens Medical Solutions USA, Inc
Apr 17, 2020 Cios Alpha Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA20-10... The unplugging of the main cable on the monitor trolley from the X10 connector can cause an unsaf... Class II Siemens Medical Solutions USA, Inc
Apr 17, 2020 Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-103... The unplugging of the main cable on the monitor trolley from the X10 connector can cause an unsaf... Class II Siemens Medical Solutions USA, Inc
Apr 10, 2020 Philips Zenition 50, System code 718096 - Product Usage: The devices are used... When strain relief is lost at the stand side of the Stand MVS Trolley Cable, over time one or mor... Class II Philips North America, LLC
Apr 10, 2020 Philips Zenition 70, System code 718133 - Product Usage: The devices are used... When strain relief is lost at the stand side of the Stand MVS Trolley Cable, over time one or mor... Class II Philips North America, LLC
Mar 30, 2020 iQ200 Series Urine Microscopy Analyzer- All part numbers A defect in the SATA power adapter cable within the instrument s computer has the potential risk ... Class II Beckman Coulter Inc.
Mar 30, 2020 iChem¿VELOCITY Urine Chemistry System- A defect in the SATA power adapter cable within the instruments computer has the potential risk f... Class II Beckman Coulter Inc.
Mar 18, 2020 H12+ and patient cable for the H12+ Holter Recorders with the following devic... Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... Class II WELCH ALLYN, INC/MORTARA
Mar 18, 2020 S4 and patient cable for the S4 Wireless Telemeter with the following device ... Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... Class II WELCH ALLYN, INC/MORTARA
Mar 18, 2020 ELI PC. The ELI PC Service automatically converts resting ECG recordings coll... Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... Class II WELCH ALLYN, INC/MORTARA
Mar 18, 2020 Q-Stress/XScribe. Q-Stress or XScribe is a diagnostic device capable of real ... Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... Class II WELCH ALLYN, INC/MORTARA
Mar 18, 2020 Q-Tel. The Q-Tel RMS system is a computer-based cardiac and pulmonary rehabil... Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... Class II WELCH ALLYN, INC/MORTARA
Mar 18, 2020 T12. Incorporates wireless electrocardiographic technology to achieve the rea... Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... Class II WELCH ALLYN, INC/MORTARA
Mar 18, 2020 Replaceable lead set for the Wireless Acquisition Module (WAM), which is the ... Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... Class II WELCH ALLYN, INC/MORTARA
Mar 18, 2020 Surveyor S12/S19 and patient cable for the S12/S19 Bedside Monitor under the ... Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... Class II WELCH ALLYN, INC/MORTARA
Mar 18, 2020 Lead diagnostic electrocardiograph under the following device names: ELI 10, ... Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... Class II WELCH ALLYN, INC/MORTARA
Mar 18, 2020 X12+ and patient cable for the X12+ Telemeter with the following device name:... Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... Class II WELCH ALLYN, INC/MORTARA
Feb 17, 2020 AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ Electrode... hearing performance degradation due to body-fluid entering the device. Class II Advanced Bionics, LLC
Feb 17, 2020 AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product Usa... hearing performance degradation due to body-fluid entering the device. Class II Advanced Bionics, LLC
Jan 21, 2020 Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimen... When excessive amounts of urine spills on the rack transport track and reaches the electrical co... Class II Sysmex America, Inc.
Jan 13, 2020 Telescopic Smoke Evac Pencil, PB, Coated, Product No. SHKTSPCL. The product ... Hairline fractures in a component could allow electrical current to arc out of the device, result... Class II Stryker Instruments Div. of Stryker 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.