Browse Device Recalls

2,260 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,260 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 2,260 FDA device recalls in 2021.

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DateProductReasonClassFirm
Jul 9, 2021 Edwards PediaSat Oximetry Catheter Set, REF: XT358KTP, Exterior Diameter 5.5F... There is a potential for internal leaks within catheters. Class II Edwards Lifesciences, LLC
Jul 9, 2021 COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the ... A sterility assurance level of 10-6 cannot be guaranteed due to intentional fraud and data integr... Class II Copan Italia
Jul 9, 2021 Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F... There is a potential for internal leaks within catheters. Class II Edwards Lifesciences, LLC
Jul 9, 2021 Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5... There is a potential for internal leaks within catheters. Class II Edwards Lifesciences, LLC
Jul 9, 2021 Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F ... There is a potential for internal leaks within catheters. Class II Edwards Lifesciences, LLC
Jul 9, 2021 Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F... There is a potential for internal leaks within catheters. Class II Edwards Lifesciences, LLC
Jul 9, 2021 Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) ... Specific PINs of the Vectris SureScan MRI lead kits contain the incorrect lead electrode spacing ... Class II Medtronic Neuromodulation
Jul 9, 2021 CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thromb... CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance Class II Ortho8, Inc.
Jul 8, 2021 Zippie Voyage, early intervention stroller - Product Usage: is manually opera... The seating system unexpectedly detached, which resulted in the seating system falling to the gro... Class II Sunrise Medical (US) LLC
Jul 8, 2021 Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRU... Due to failure to acquire pre-market clearance for its high resolution tomographic/biomicroscope ... Class II Carl Zeiss Meditec, Inc.
Jul 8, 2021 The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular... The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S.... Class II Vascutek, Ltd.
Jul 8, 2021 Zippie Voyage, early intervention stroller - Product Usage: is manually opera... The seating system unexpectedly detached, which resulted in the seating system falling to the gro... Class II Sunrise Medical (US) LLC
Jul 8, 2021 The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-... The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S.... Class II Vascutek, Ltd.
Jul 8, 2021 Scorpion Portal Vein Access Set - Product Usage: used to gain access to the h... As a result of design changes, sheaths have exhibited cracking/breaking at the tips. Class II Argon Medical Devices, Inc
Jul 7, 2021 Dose IQ Safety Software used with Spectrum IQ Infusion Pump Software issue: The defect creates a mismatch between linked drug identifiers (IDs) in the Dose ... Class I Baxter Healthcare Corporation
Jul 6, 2021 Advance Dx 100 Blood Collection Card Quantity 25 REF CMT01 Advance Dx 100... Due to high glucose test results when using the blood collection cards. Class II Advance Dx, Inc.
Jul 6, 2021 Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the ... Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days... Class II Siemens Healthcare Diagnostics, Inc
Jul 6, 2021 Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic... Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days... Class II Siemens Healthcare Diagnostics, Inc
Jul 6, 2021 Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the ... Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days... Class II Siemens Healthcare Diagnostics, Inc
Jul 5, 2021 CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW releas... An incorrect error messaging system that could potentially lead to: 1) Reporting a thermal event ... Class II Zeltiq Aesthetics, Inc
Jul 2, 2021 Torque Limiting Adaptor, AO Connect, 4 N-m, part #027-203, reusable, a compon... There is a risk of breakage of the torque limiting adaptor if used counterclockwise and it must n... Class II Laboratoires Bodycad, Inc.
Jul 2, 2021 The Hero Model 100 (H-100) is a system consisting of a smart pill dispenser a... Due to dispenser prompting for a missed dose that had already been dispensed Class II Hero Health
Jul 1, 2021 Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.... SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect... Class II Beckman Coulter Inc.
Jul 1, 2021 Medline Shoulder CDS convenience kits, REF DYNJ902837D and REF DYNJ902837F, c... The kits may contain an expired component. Class II Medline Industries Inc
Jul 1, 2021 Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700 The internal profile of the Triathlon Prim (Baseplate) is potentially oversized; there may be a w... Class II Howmedica Osteonics Corp.
Jul 1, 2021 Medline Total Knee, convenience kit, REF DYNJ907129B, containing expired com... The kits may contain an expired component. Class II Medline Industries Inc
Jul 1, 2021 Potassium Hydroxide 10% (KOH 10%), Cat. No. 300145 Potassium Hydroxide 10%... A lot of KOH 10% was made with Hydrogen Peroxide 3% instead of KOH 10%. Class II Gibson Bioscience
Jul 1, 2021 ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713; SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect... Class II Beckman Coulter Inc.
Jul 1, 2021 Medline Knee Arthroscopy Kit, convenience kit, REF DYNJ902838C, containing e... The kits may contain an expired component. Class II Medline Industries Inc
Jul 1, 2021 ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthropl... Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a re... Class II DePuy Orthopaedics, Inc.
Jul 1, 2021 ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTIO... SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect... Class II Beckman Coulter Inc.
Jul 1, 2021 ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 ... SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect... Class II Beckman Coulter Inc.
Jul 1, 2021 GlideScope Go Monitors Handheld video monitor failed to meet the labeled IP67 rating which may allow fluid ingress into ... Class III Verathon, Inc.
Jul 1, 2021 Medline Arthroscopy Kit, convenience kit, REF DYNJ904304B, containing expire... The kits may contain an expired component. Class II Medline Industries Inc
Jun 30, 2021 LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery. Customized coronal rod benders may deform the implant when used with the spinal system devices. Class II Aesculap Implant Systems LLC
Jun 30, 2021 Revolution CT, Revolution CT ES The accumulated dose is incorrectly displayed in certain situations. There are two situations tha... Class II GE Healthcare, LLC
Jun 30, 2021 The system is intended to produce cross-sectional images of the body by compu... When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a... Class II GE Healthcare, LLC
Jun 30, 2021 Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Wo... Units are displaying output readings that differ from the measurements taken using a Gas Analyzer... Class II CooperSurgical, Inc.
Jun 30, 2021 Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution ... The accumulated dose is incorrectly displayed in certain situations. Thisoccurs during an interve... Class II GE Healthcare, LLC
Jun 30, 2021 Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser ... Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded ... Class II Olympus Corporation of the Americas
Jun 30, 2021 The system is intended to produce cross-sectional images of the body by compu... When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a... Class II GE Healthcare, LLC
Jun 30, 2021 Kaguya Automated Peritoneal Dialysis System Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used wi... Class II BAXTER HEALTHCARE CORPORATION
Jun 30, 2021 Prelude SNAP Splittable Sheath Introducer, REF: PLS-1007, size 7F, Standard L... There is a potential that 7F sheaths are packaged as 10F sheaths. Class II Merit Medical Systems, Inc.
Jun 30, 2021 Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation duri... The screw cover at the tip of the probe may fall off after a cleaning and sterilization process. ... Class II Hitachi Healthcare Americas Corporation
Jun 30, 2021 RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery. Customized coronal rod benders may deform the implant when used with the spinal system devices. Class II Aesculap Implant Systems LLC
Jun 30, 2021 Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standar... There is a potential that 7F sheaths are packaged as 10F sheaths. Class II Merit Medical Systems, Inc.
Jun 30, 2021 Sharesource Connectivity Platform for Use with the Amia Automated PD System Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used wi... Class II BAXTER HEALTHCARE CORPORATION
Jun 30, 2021 Revolution Apex, Revolution CT with Apex Edition The accumulated dose is incorrectly displayed in certain situations. There are two situations tha... Class II GE Healthcare, LLC
Jun 30, 2021 Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Ar... Due to a software error, the IAS (Image Acquisition System) may sporadically fail during startup/... Class II Siemens Medical Solutions USA, Inc
Jun 30, 2021 The system is intended to produce cross-sectional images of the body by compu... When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a... Class II GE Healthcare, LLC

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.