Browse Device Recalls
2,602 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,602 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 2,602 FDA device recalls in 2020.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 28, 2020 | Safe-T-Centesis PLUS 8 Fr Catheter Drainage Tray | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 28, 2020 | Safe-T PLUS Thora-Para 5 Fr Catheter Drainage Tray | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 27, 2020 | Prodimed Combicath catheters for blind or fibrescope-guided protected distal ... | Lack of assurance of sterility | Class II | Prodimed Plastimed Division |
| May 27, 2020 | Prodimed Combicath Paediatric catheters for blind protected distal bronchial ... | Lack of assurance of sterility | Class II | Prodimed Plastimed Division |
| May 27, 2020 | Prodimed Combicath catheters for blind or fibrescope-guided protected distal ... | Lack of assurance of sterility | Class II | Prodimed Plastimed Division |
| May 27, 2020 | RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens M... | The scanner is not confirming the integrity of read barcode data using the check-digit when readi... | Class II | Siemens Healthcare Diagnostics Inc |
| May 27, 2020 | Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH ... | Lack of assurance of sterility | Class II | Prodimed Plastimed Division |
| May 27, 2020 | Prodimed Combicath Paediatric catheters for blind protected distal bronchial ... | Lack of assurance of sterility | Class II | Prodimed Plastimed Division |
| May 27, 2020 | Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH ... | Lack of assurance of sterility | Class II | Prodimed Plastimed Division |
| May 26, 2020 | Pediatric Adjustable Flange Tracheostomy Tube Cuffless | One lot of 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes wa... | Class II | Smiths Medical ASD Inc. |
| May 26, 2020 | RayStation standalone software treatment planning system (RayStation 8A, 8B, ... | It is not obvious that the manual import of a treatment record into RayCare PACS does not automat... | Class II | RAYSEARCH LABORATORIES AB |
| May 26, 2020 | Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 3... | Potential risk of patient mix-up on analyzers due to software issues. | Class II | Radiometer Medical ApS |
| May 26, 2020 | ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPIN... | 6.0x50mm poly-reduction screws were laser etched 6.0x45 | Class II | U&I CORP. |
| May 26, 2020 | Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 3... | Potential risk of patient mix-up on analyzers due to software issues. | Class II | Radiometer Medical ApS |
| May 23, 2020 | Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 In... | Two issues were identified with the computed tomography x-ray system including a service function... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| May 22, 2020 | Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interfac... | Lateromedial (LM) and Lateromedial Oblique (LMO) Orientation Markers may be displayed incorrectly... | Class II | Fujifilm Medical Systems U.S.A., Inc. |
| May 22, 2020 | TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 ... | High rate of reported complaints for the loss of contact force information while using the TactiC... | Class II | Abbott |
| May 22, 2020 | AIA-900 Analyzer, Part no. 022930, UDI 04560189283992 | The Substrate Monitoring System in the AIA-900 Analyzer did not detect an empty substrate bottle.... | Class II | Tosoh Bioscience Inc |
| May 22, 2020 | ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F | Due to adverse events received by the firm for left atrial perforations and Atrioventricular Node... | Class II | Siemens Medical Solutions USA, Inc. |
| May 21, 2020 | Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, ... | In TSM (Treatment Session Manager) Motion Monitoring workflows, under certain conditions there ca... | Class II | Elekta Limited |
| May 21, 2020 | VistaSolution, physiological signal transmitter. A software graphical user in... | A healthcare provider (HCP) noticed a patient had a lowered historic SpO2 reading that the softwa... | Class II | Vitalconnect Inc. |
| May 20, 2020 | VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Un... | Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset ... | Class II | Ortho Clinical Diagnostics |
| May 20, 2020 | VITROS 5600 Integrated System Software Versions 3.3.3 and below Product C... | Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset ... | Class II | Ortho Clinical Diagnostics |
| May 20, 2020 | Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 SPANISH, Product Code IAP-0... | A potential issue with a component within the above-referenced IABPs may impact the ability of th... | Class I | Arrow International Inc |
| May 20, 2020 | Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH, Product Code ... | A potential issue with a component within the above-referenced IABPs may impact the ability of th... | Class I | Arrow International Inc |
| May 20, 2020 | Arrow AutoCAT2 Intra-Aortic Balloon Pump AEROAUTOCAT 2 WAVE, Product Code IAP... | A potential issue with a component within the above-referenced IABPs may impact the ability of th... | Class I | Arrow International Inc |
| May 20, 2020 | Leica ARveo and M530 OH6 microscope systems. | Possible unintended interruption of surgical procedures due to equipment shutdown, related to cha... | Class II | Leica Microsystems, Inc. |
| May 20, 2020 | Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA, Product... | A potential issue with a component within the above-referenced IABPs may impact the ability of th... | Class I | Arrow International Inc |
| May 20, 2020 | VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Produ... | Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset ... | Class II | Ortho Clinical Diagnostics |
| May 20, 2020 | Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code ... | A potential issue with a component within the above-referenced IABPs may impact the ability of th... | Class I | Arrow International Inc |
| May 20, 2020 | VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below... | Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset ... | Class II | Ortho Clinical Diagnostics |
| May 20, 2020 | Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE DUTCH, Product Code IA... | A potential issue with a component within the above-referenced IABPs may impact the ability of th... | Class I | Arrow International Inc |
| May 20, 2020 | Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400 | A potential issue with a component within the above-referenced IABPs may impact the ability of th... | Class I | Arrow International Inc |
| May 20, 2020 | VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Produc... | Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset ... | Class II | Ortho Clinical Diagnostics |
| May 20, 2020 | Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code... | A potential issue with a component within the above-referenced IABPs may impact the ability of th... | Class I | Arrow International Inc |
| May 20, 2020 | Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA, Product... | A potential issue with a component within the above-referenced IABPs may impact the ability of th... | Class I | Arrow International Inc |
| May 20, 2020 | Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500 | A potential issue with a component within the above-referenced IABPs may impact the ability of th... | Class I | Arrow International Inc |
| May 19, 2020 | Isolation Droplet Bundle Kit | Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The ... | Class II | ROi CPS LLC |
| May 19, 2020 | Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The Su... | Philips has identified a Philips SureSigns VM1 monitor in the possession of a clinical user that ... | Class II | Philips North America, LLC |
| May 19, 2020 | Respirator Crash Cart Kit | Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The ... | Class II | ROi CPS LLC |
| May 18, 2020 | RayStation 8B Service Pack 1, UDI # 07350002010204 - Product Usage: For radi... | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... | Class II | RAYSEARCH LABORATORIES AB |
| May 18, 2020 | RayStation 6 Service Pack 1, UDI #s 07350002010037, 07350002010082 - Produ... | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... | Class II | RAYSEARCH LABORATORIES AB |
| May 18, 2020 | RayStation 9B, UDI # 07350002010266 - Product Usage: For radiation therapy a... | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... | Class II | RAYSEARCH LABORATORIES AB |
| May 18, 2020 | RayStation 6, UDI # 07350002010013 - Product Usage: For radiation therapy and... | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... | Class II | RAYSEARCH LABORATORIES AB |
| May 18, 2020 | RayStation 4.0 to RayStation 5 Service Pack 2 - Product Usage: For radiation ... | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... | Class II | RAYSEARCH LABORATORIES AB |
| May 18, 2020 | RayStation 8B Service Pack 2, UDI # 07350002010235 - Product Usage: For radi... | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... | Class II | RAYSEARCH LABORATORIES AB |
| May 18, 2020 | RayStation 7, UDI # 07350002010068 - Product Usage: For radiation therapy an... | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... | Class II | RAYSEARCH LABORATORIES AB |
| May 18, 2020 | Mueller Knife Handle, Hexagonal - Product Usage: Intended to hold surgical bl... | Becton Dickinson and Company, is conducting a voluntary recall on the V. MuellerTM 3H Knife Handl... | Class II | Carefusion 2200 Inc |
| May 18, 2020 | RayStation 8A, UDI # 07350002010112 - Product Usage: For radiation therapy an... | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... | Class II | RAYSEARCH LABORATORIES AB |
| May 18, 2020 | RayStation 9B Service Pack 1, UDI # 07350002010297 - Product Usage: For radi... | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... | Class II | RAYSEARCH LABORATORIES AB |
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.