Browse Device Recalls
1,646 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,646 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 1,646 FDA device recalls in MN.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 4, 2020 | Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Azure S SR MRI, Model Number W3SR01 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Azure S DR MRI, Model Number W3DR01 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Patient Connector, Model Number 24967 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | CareLink SmartSync Device Manager, Model Number 24970A | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| 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 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 |
| Mar 24, 2020 | CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L ... | Specific Pumps may exhibit intermittent performance in the AILD (Air in Line Detector) function. ... | Class I | Smiths Medical ASD Inc. |
| Mar 16, 2020 | Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium ... | The inner lumen of the Langston catheter may separate from the hub during pressure injection. | Class I | Vascular Solutions, Inc. |
| Mar 10, 2020 | smiths medical medex HemoDraw Plus Closed Blood Sampling Set with LogiCal Pre... | 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 Antishunt set, (172/15cm), Model Number DPSHC0091 | 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, einfach 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 5 ml, zweifach 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 5 ml, Antishunt proximaler Entnahmeport 60 cm, Mode... | 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 2-fach Druckmesset mit Option, Model Number DPSHC0076 | 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, 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. |
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.