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
Mar 8, 2021 BIOTRONIK Iforia 7,DR-T, DF-1,REF 390064, UDI: 04035479126926 - Product Usage... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK ITREVIA 7, DR-T QP DF-1, REF 392412, UDI: 04035479128807 - Product... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK ILIVIA 7, DR-T DF-1 PROMRI, REF 404622, UDI: 04035479142094 - Produ... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK Ilestro 7 DR-T, DF-4, REF383564, UDI: 04035479125202 - Product Usag... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK Ilestro 7 VR-T, DF-4, REF 383580, UDI: 04035479125363 - Product Usa... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK IPERIA 7,VR-T, DX, DF-1, ProMRI, REF 393032, UDI: 04035479129477 - ... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK ITREVIA 7, VR-T DF-1, REF 393040, UDI: 04035479129552 - Product Usa... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK ILIVIA 7, VR-T DF4 ProMRI, REF 404626, UDI: 04035479142131 - Produ... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK Ilestro 7 DR-T, DF-1, REF383562, UDI: 04035479125189 - Product Usag... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK ITREVIA 7, VR-T DF-4, REF 393041, UDI: 04035479129569 - Product Usa... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK ILIVIA NEO 7 DR-T DF-1 ProMRI, REF 429529, UDI: 04035479156749 - Pr... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm... Difficulty inserting the biopsy ejector rod into the bone lesion biopsy cannula, preventing the b... Class II Arrow International Inc
Mar 8, 2021 BIOTRONIK INVENTRA 7, HF-T QP DF4 IS4, REF 393012, UDI: 04035479129286 - Pro... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK Ilestro 7 VR-T DX, DF-1, REF 383594, UDI: 04035479125509 - Product ... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK Ilestro 7 VR-T, DF-1, REF 383578, UDI: 04035479125349 - Product Usa... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 5, 2021 ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - US, automated hematolog... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, Inc.
Mar 5, 2021 ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - US, automated hematology... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, Inc.
Mar 5, 2021 ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - US, automated hematology a... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, Inc.
Mar 5, 2021 ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - US, automated hematol... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, Inc.
Mar 5, 2021 MAMBA Microcatheter. Packaged with protective sleeve over catheter, sealed i... The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters du... Class II Boston Scientific Corporation
Mar 5, 2021 ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - OUS, automated ... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, Inc.
Mar 5, 2021 ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US, automated hematology ... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, Inc.
Mar 5, 2021 ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - OUS, automated hematolo... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, Inc.
Mar 5, 2021 Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in ske... Centinel Spine learned through five customer complaints that the product was missing the "UP" etc... Class II Centinel Spine, Inc.
Mar 5, 2021 ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - OUS, aut... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, Inc.
Mar 5, 2021 ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - OUS, automated hematol... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, Inc.
Mar 5, 2021 Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Re... The posterior condyle of the Specialty Triathlon TS Trial Cutting Guide(s), sizes 1 through 8, (L... Class II Howmedica Osteonics Corp.
Mar 5, 2021 ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, automated hematology ... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, Inc.
Mar 5, 2021 Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cuttin... Investigations related to customer complaints received for particulate matter inside of the Surgi... Class II Covidien
Mar 5, 2021 ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - OUS, automated hematology a... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, Inc.
Mar 5, 2021 ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - US, automated hematology a... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, Inc.
Mar 5, 2021 ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - US, automated... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, Inc.
Mar 5, 2021 ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - OUS, automated hematology ... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, Inc.
Mar 5, 2021 ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated he... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, Inc.
Mar 5, 2021 ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - OUS, automated hematology... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, Inc.
Mar 5, 2021 ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS, automated h... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, Inc.
Mar 5, 2021 ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - US, automated h... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, Inc.
Mar 5, 2021 ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - US, aut... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, Inc.
Mar 5, 2021 MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter,... The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters du... Class II Boston Scientific Corporation
Mar 5, 2021 ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - OUS, automated ... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, Inc.
Mar 4, 2021 Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascu... Potential for the device safety interlock to fail. The safety interlock prevents an empty single-... Class II Covidien, LP
Mar 4, 2021 Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated... Due to the configuration of certain Windows Service Permissions within the operating systems of... Class II Siemens Medical Solutions USA, Inc
Mar 4, 2021 Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm Vascular/... Potential for the device safety interlock to fail. The safety interlock prevents an empty single-... Class II Covidien, LP
Mar 4, 2021 Maxi Sky 1000 (Arjo) and V10 (BHM) Bariatric Ceiling Rail - Mounted Lift with... The spreader bar can disconnect from the scale bottom attachment. Class II Arjohuntleigh Magog, Inc.
Mar 4, 2021 Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/T... Potential for the device safety interlock to fail. The safety interlock prevents an empty single-... Class II Covidien, LP
Mar 4, 2021 Regard, Item Number 830067009, custom cardiovascular procedure kit ROi CPS, LLC has become aware, through a vendor issued urgent medical device recall notice, that ... Class II ROi CPS LLC
Mar 3, 2021 Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed t... SOMATOM systems-issues in with software syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a, may result in... Class II Siemens Medical Solutions USA, Inc
Mar 3, 2021 RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information s... Patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCa... Class II RAYSEARCH LABORATORIES AB
Mar 3, 2021 Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers... An electrical component within the system controller module of certain Bio-Console 560 devices ma... Class I Medtronic Perfusion Systems
Mar 3, 2021 BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module... Pump Module keypad lifting, and Fluid ingress could result in 1) Unresponsive keys: module contin... Class I CareFusion 303, Inc.

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.