Browse Device Recalls

1,677 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,677 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 1,677 FDA device recalls in MN.

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DateProductReasonClassFirm
Mar 10, 2020 smiths medical medex CBSS-5ML, Double set, (172+15cm), Model Number DPSHC0094 Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System ... Class II Smiths Medical ASD Inc.
Mar 10, 2020 medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1... Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System ... Class II Smiths Medical ASD Inc.
Mar 10, 2020 smiths medical medex CBSS 5 ml, dreifach proximaler Entnahmeport 60 cm, Model... Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System ... Class II Smiths Medical ASD Inc.
Mar 10, 2020 smiths medical medex CBSS-5ML, Single Set, (172/15cm), Model Number DPSHC0093 Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System ... Class II Smiths Medical ASD Inc.
Mar 10, 2020 smiths medical medex CBSS-5ML Zweifach set, Model Number DPSHC0090 Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System ... Class II Smiths Medical ASD Inc.
Mar 10, 2020 smiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092 Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System ... Class II Smiths Medical ASD Inc.
Feb 28, 2020 Portex Lumbar Puncture Tray. Anesthesia Conduction Kit. 4826PL-20 - Product U... Cases of Portex¿ Lumbar Puncture Tray Child, SKU #4826PL-20 had been mislabeled with invalid inf... Class II Smiths Medical ASD Inc.
Feb 18, 2020 KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2... Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of sp... Class II Microbiologics Inc
Feb 18, 2020 QC Sets and Panels, KWIK-STIK AST-GP (6 Strains) QC Set. KWIK-STIK kit that ... Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of sp... Class II Microbiologics Inc
Feb 18, 2020 LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic ... Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of sp... Class II Microbiologics Inc
Feb 18, 2020 QC Sets and Panels, KWIK-STIK Blood Culture Identification (BCID) Verificatio... Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of sp... Class II Microbiologics Inc
Feb 18, 2020 QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. KWIK-STIK kit that ... Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of sp... Class II Microbiologics Inc
Feb 12, 2020 KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 077... KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive QC Set (REF 5195P) ... Class II Microbiologics Inc
Feb 12, 2020 Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR,... Boston Scientific released a new Software Update Application that was downloaded to four (4) dist... Class II Boston Scientific Corporation
Feb 12, 2020 Microbiologics QC SETS AND PANELS, YST Comprehensive QC Set, REF 5195P, conta... KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive QC Set (REF 5195P) ... Class II Microbiologics Inc
Feb 12, 2020 Boston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:Th... Boston Scientific released a new Software Update Application that was downloaded to four (4) dist... Class II Boston Scientific Corporation
Feb 11, 2020 Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm Medtronic received a complaint from China that the label on the box for an Open Pivot Heart Valve... Class II MEDTRONIC ATS MEDICAL, INC.
Feb 11, 2020 Imager II 5F Angiographic Catheters, 5 units per package. Potential for tip detachment of Imager II 5F Angiographic Catheters Class I Boston Scientific Corporation
Jan 30, 2020 Medtronic CareLink Encore 29901 Programmer. Used to interrogate and program... Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: imp... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 30, 2020 Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtroni... Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: imp... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 22, 2020 Braemar Manufacturing LLC DL900 Holter Monitor 1285 Corporate Center Dr. S... An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This ... Class II Braemar Manufacturing, LLC
Jan 22, 2020 Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. S... An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This ... Class II Braemar Manufacturing, LLC
Jan 3, 2020 Vaginal Verification Panel Ref 8208 Lot 8208-11 Product 8208 Vaginal Verification Panel is a 6 pool kit and has contaminant Candida krusei in Poo... Class II Microbiologics Inc
Dec 16, 2019 Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel ... The recommended hydration fluid for the 8180 Gram-Positive Blood Culture Control Panel (Inactivat... Class II Microbiologics Inc
Dec 9, 2019 Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 40... Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths ins... Class II Abbott Medical
Dec 9, 2019 Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303 Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of ... Class II Abbott Medical
Nov 26, 2019 iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgica... There is a potential hardware error for the iMRX System with a generator A100. A tolerance issue... Class II Deerfield Imaging, Inc.
Nov 21, 2019 3M Durapore Advanced, Surgical Tape, Model Numbers: 1590-0, 1590-1, 1590-2, 1... While the product meets all safety and efficacy criteria, long term exposure of 3M Durapore Advan... Class II 3M Company - Health Care Business
Nov 14, 2019 Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351 Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in t... Class II Medtronic Perfusion Systems
Nov 11, 2019 CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF... A manufacturing error caused a single lot of 10mm active tip length Cannulas to be labeled as 5mm... Class II Abbott Medical
Oct 28, 2019 Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightwei... There is an anomaly in Medfusion 4000 Syringe Pump Firmware version 1.7.0 that could potentially ... Class I Smiths Medical ASD Inc.
Oct 25, 2019 Visual-ICE Cryoablation System, FPRCH6000. The cryoablation system is a mobi... Visual-ICE utilizing the IceSeed 1.5 and IceRod 1.5 PLUS cryoablation needles could have issues w... Class II Galil Medical, Inc.
Oct 24, 2019 Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. P... Certain dilation and extension catheters are being recalled because these catheters may have miss... Class II Boston Scientific Corporation
Oct 24, 2019 Rebel Monorail PtCr Coronary Stent System, REF / Catalog No. H7493927324300, ... Certain dilation and extension catheters are being recalled because these catheters may have miss... Class II Boston Scientific Corporation
Oct 24, 2019 Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide. Pack... Certain dilation and extension catheters are being recalled because these catheters may have miss... Class II Boston Scientific Corporation
Oct 24, 2019 NC Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide... Certain dilation and extension catheters are being recalled because these catheters may have miss... Class II Boston Scientific Corporation
Oct 18, 2019 Aequalis Ascend Flex Humeral Stem: Part Number UDI DWF601A 3700386944475 D... During shipping, it is possible for the Aequalis Ascend Flex humeral stem to become unseated or o... Class II Tornier, Inc
Oct 14, 2019 Radiofrequency Grounding Pad, REF RF-DGP-L Affected lots were manufactured with the protective release liner in an incorrect orientation. W... Class II Abbott Medical
Oct 11, 2019 Synchromed II programmable pump, Model numbers 8637-20 and 8637-40 There is a potential for the presence of a foreign particle inside the pump motor assembly which ... Class I Medtronic Neuromodulation
Oct 9, 2019 Medivators Endo Smartcap Endoscope Tubing. REF100145. Packaged as Contents ... Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present duri... Class II Medivators, Inc.
Oct 9, 2019 Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXT, packaged as Con... Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present duri... Class II Medivators, Inc.
Oct 9, 2019 Medivators Endo Smartcap Endoscope Tubing. REF100145CO2, packaged as Conten... Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present duri... Class II Medivators, Inc.
Oct 9, 2019 Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 Series GI E... Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present duri... Class II Medivators, Inc.
Oct 9, 2019 Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI E... Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present duri... Class II Medivators, Inc.
Oct 9, 2019 Medivators Endo carry-on Procedure Kit REF CPK-100222-0002 - Product Usage: ... Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present duri... Class II Medivators, Inc.
Oct 9, 2019 Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXTU, packaged as Co... Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present duri... Class II Medivators, Inc.
Oct 3, 2019 Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer There is a potential for Medtronic programmer and remote monitoring software applications to disp... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Oct 3, 2019 Programmers & Remote Monitoring Software Apps: CareLink SmartSync Device Man... There is a potential for Medtronic programmer and remote monitoring software applications to disp... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Oct 3, 2019 Programmers & Remote Monitoring Software Apps: 29901 CareLink Encore Programmer There is a potential for Medtronic programmer and remote monitoring software applications to disp... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Aug 21, 2019 Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled a... Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL)... Class II Boston Scientific 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.