Browse Device Recalls

3,505 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,505 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 3,505 FDA device recalls in MA.

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DateProductReasonClassFirm
Oct 21, 2015 LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model ... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicat... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indi... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 14, 2015 Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M,... The following MRx software issue has been identified: MRx model M3535A with software version F.03... Class II Philips Electronics North America Corporation
Oct 1, 2015 Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura... Upon initiating Fluoroscopy the user may encounter a user message Fluoro failed. Class II Philips Electronics North America Corporation
Sep 17, 2015 Philips DuraDiagnost stationary X-ray system Buttons or keys on the monitor allow the user to turn the volume setting down to 0", in which ca... Class II Philips Electronics North America Corporation
Sep 14, 2015 Samsung GM60A-40S Intended for use in generating radiographic images of hu... When the system is driving over a non-conductive floor and then over a conductive, grounded part,... Class II NeuroLogica Corporation
Sep 10, 2015 Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 8.5 mm, Sterile ... Sterility of device is compromised due to breach in the packaging Class II Smith & Nephew, Inc., Endoscopy Div.
Sep 10, 2015 Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile ... Sterility of device is compromised due to breach in the packaging Class II Smith & Nephew, Inc., Endoscopy Div.
Sep 10, 2015 Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile ... Sterility of device is compromised due to breach in the packaging Class II Smith & Nephew, Inc., Endoscopy Div.
Sep 10, 2015 Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile ... Sterility of device is compromised due to breach in the packaging Class II Smith & Nephew, Inc., Endoscopy Div.
Sep 6, 2015 Philips Healthcare Ingenuity CT Computed Tomography X-Ray System Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series d... Class II Philips Healthcare
Sep 6, 2015 Philips Healthcare Ingenuity Core Computed Tomography X-Ray System Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series d... Class II Philips Healthcare
Sep 6, 2015 Philips Healthcare Ingenuity Core128 Computed Tomography X-Ray System Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series d... Class II Philips Healthcare
Sep 6, 2015 Philips Healthcare Ingenuity Elite Computed Tomography X-Ray System Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series d... Class II Philips Healthcare
Sep 6, 2015 Philips Healthcare Brilliance iCT SP Computed Tomography X-Ray System Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series d... Class II Philips Healthcare
Sep 6, 2015 Philips Healthcare Brilliance 64 Computed Tomography X-Ray System Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series d... Class II Philips Healthcare
Sep 6, 2015 Philips Healthcare Brilliance iCT Computed Tomography X-Ray System Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series d... Class II Philips Healthcare
Aug 31, 2015 ConFormis iDUO G2, Right Lateral Catalog Number: M5723INT0600240 (US) ... May contain small amounts of ethylene glycol residue Class II ConforMIS, Inc.
Aug 31, 2015 ConForMIS Unicondylar Knee Replacement System iUNI G2, Left Medial Catalog ... May contain small amounts of ethylene glycol residue Class II ConforMIS, Inc.
Aug 31, 2015 ConFormis iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT... May contain small amounts of ethylene glycol residue Class II ConforMIS, Inc.
Aug 31, 2015 ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, L... May contain small amounts of ethylene glycol residue Class II ConforMIS, Inc.
Aug 31, 2015 ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IP... May contain small amounts of ethylene glycol residue Class II ConforMIS, Inc.
Aug 31, 2015 ConForMIS iDuo Knee Bicompartmental Knee Replacement System , iDUO G2, Right ... May contain small amounts of ethylene glycol residue Class II ConforMIS, Inc.
Aug 31, 2015 ConForMIS iDuo Bicompartmental Knee Replacement System iDUO G2, Left Lateral... May contain small amounts of ethylene glycol residue Class II ConforMIS, Inc.
Aug 31, 2015 ConForMIS iUNI Unicondylar Knee Replacement System iUNI G2, Right Lateral ... May contain small amounts of ethylene glycol residue Class II ConforMIS, Inc.
Aug 31, 2015 ConForMIS iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial C... May contain small amounts of ethylene glycol residue Class II ConforMIS, Inc.
Aug 31, 2015 ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog ... May contain small amounts of ethylene glycol residue Class II ConforMIS, Inc.
Aug 31, 2015 ConForMIS iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral ... May contain small amounts of ethylene glycol residue Class II ConforMIS, Inc.
Aug 24, 2015 Siemens RAPIDPoint 500 Measurement Cartridge Lactate (250) tests Part Number... RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodiu... Class II Siemens Healthcare Diagnostics Inc
Aug 24, 2015 Siemens RAPIDPoint 500 Measurement Cartridge Lactate (400) tests Part Number... RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodiu... Class II Siemens Healthcare Diagnostics Inc
Aug 24, 2015 Terumo Custom Cardiovascular Procedure Kit X-Coated Adult Pak P/N: 73124 Te... Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performanc... Class II Terumo Cardiovascular Systems Corp
Aug 24, 2015 Siemens RAPIDPoint 500 Measurement Cartridge Lactate (100) tests Part Number... RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodiu... Class II Siemens Healthcare Diagnostics Inc
Aug 24, 2015 Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/... Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performanc... Class II Terumo Cardiovascular Systems Corp
Aug 24, 2015 Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack P/N: 74... Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performanc... Class II Terumo Cardiovascular Systems Corp
Aug 24, 2015 Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/... Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performanc... Class II Terumo Cardiovascular Systems Corp
Aug 24, 2015 Terumo Custom Cardiovascular Procedure Kit X-Coated Pediatric Pack P/N: 74... Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performanc... Class II Terumo Cardiovascular Systems Corp
Aug 24, 2015 Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack with FX25R... Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performanc... Class II Terumo Cardiovascular Systems Corp
Aug 24, 2015 Terumo Custom Cardiovascular Procedure Kit Tubing Pack P/N: 66041-1 Terumo ... Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performanc... Class II Terumo Cardiovascular Systems Corp
Aug 24, 2015 Siemens RAPIDPoint 500 Measurement Cartridge Lactate (750 tests) Part Number... RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodiu... Class II Siemens Healthcare Diagnostics Inc
Jul 28, 2015 RAPIDPoint 500 Blood Gas Analyzer, Siemens Material Numbers (SMN):10492730, ... When both ports (Serial and Ethernet) are configured to transmit data, the data stream from one p... Class II Siemens Healthcare Diagnostics Inc
Jul 27, 2015 ADVIA Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Use... Low red blood cell control recoveries and low results for red blood cell patient samples when usi... Class II Siemens Healthcare Diagnostics, Inc
Jul 23, 2015 Philips GoSafe Mobile Help Button; 7000MHB. Personal Emergency Response Sy... Irregular battery disconnection resulted in issues with Mobile Health Button (MHB) Charging. Class II Lifeline Systems, Incorporated
Jul 22, 2015 Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A ra... If arm is not fastened securely it could fall down. Class II Philips Electronics North America Corporation
Jul 16, 2015 Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Conce... Expansion of recall to lots manufactured in 2015 due to the potential for bacterial contamination. Class II Fresenius Medical Care Holdings, Inc.
Jul 13, 2015 OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Cat... OmniPods¿ (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing ... Class I Insulet Corporation
Jul 13, 2015 OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Ca... OmniPods¿ (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing ... Class I Insulet Corporation
Jul 6, 2015 Actuator for angiographic x-ray monitor ceiling suspension system. Actuator ... The actuator assembly became detached and the monitor carriage with a flexvision monitor dropped ... Class II Philips Electronics North America Corporation
Jul 6, 2015 SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T an... Wrong positioning of the coil cables can create unintended resonances via the patient or elevated... Class II Philips Electronics North America Corporation
Jun 17, 2015 Invivo Expression MRI Patient Monitoring System. The device's labeling inaccurately indicates Endotracheal as a body temperature application site.... Class II Philips Electronics North America 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.