Medical devices, 2020
Shortlist up to four to read them side by side.
3,055 medical device recalls FDA’s Enforcement Report published in 2020, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
3,055of 3,055 medical device recallsshown with your filters
The list
- Medical device recall Azure XT DR MRI There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of… Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 15, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Azure S DR MRI There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of… Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 15, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Azure XT SR MRI There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of… Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 15, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Azure S SR MRI There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of… Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 15, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Percepta CRT-P MRI There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of… Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 15, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Serena CRT-P MRI There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of… Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 15, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Solara CRT-P MRI There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of… Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 15, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes Feeding tube plastic tethered closure cap may possibly fracture or break. Class IIFDA’s classJul 15, 2020in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereCalifornia, Iowa and Virginia
- Medical device recall Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes Feeding tube plastic tethered closure cap may possibly fracture or break. Class IIFDA’s classJul 15, 2020in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereCalifornia, Iowa and Virginia
- Medical device recall Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes Feeding tube plastic tethered closure cap may possibly fracture or break. Class IIFDA’s classJul 15, 2020in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereCalifornia, Iowa and Virginia
- Medical device recall Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes Feeding tube plastic tethered closure cap may possibly fracture or break. Class IIFDA’s classJul 15, 2020in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereCalifornia, Iowa and Virginia
- Medical device recall Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes Feeding tube plastic tethered closure cap may possibly fracture or break. Class IIFDA’s classJul 15, 2020in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereCalifornia, Iowa and Virginia
- Medical device recall Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes Feeding tube plastic tethered closure cap may possibly fracture or break. Class IIFDA’s classJul 15, 2020in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereCalifornia, Iowa and Virginia
- Medical device recall Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes Feeding tube plastic tethered closure cap may possibly fracture or break. Class IIFDA’s classJul 15, 2020in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereCalifornia, Iowa and Virginia
- Medical device recall uDR 596i Digital Medical X-Ray Imaging System - Product Usage: intended to use by a qualified/ trained doctor… Two issues were identified with the stationary x-ray system. Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereNationwide, and Texas named
- Medical device recall uCT 760 System, Computed Tomography X-ray System Two issues were identified with the computed tomography x-ray system including an intermittent issue which may affect image data leading to artifacts; and… Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportTexasthe one state its words name PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereTexas
- Medical device recall EasyDiagnost Eleva DRF Thermo switches in the main power supply for the system may be incorrectly installed, resulting in a malfunction. Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Illinois, Louisiana, Massachusetts, Maryland, Michigan, Mississippi, Montana, North Carolina, New York, Tennessee and Texas named
- Medical device recall 3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the… Lack of pouch seal. Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Hawaii, Illinois, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, Nevada, New York, Pennsylvania, Puerto Rico, Tennessee, Texas and Washington named
- Medical device recall 3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the… Lack of pouch seal. Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Hawaii, Illinois, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, Nevada, New York, Pennsylvania, Puerto Rico, Tennessee, Texas and Washington named
- Medical device recall PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in… Lack of pouch seal. Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Hawaii, Illinois, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, Nevada, New York, Pennsylvania, Puerto Rico, Tennessee, Texas and Washington named
- Medical device recall PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in… Lack of pouch seal. Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Hawaii, Illinois, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, Nevada, New York, Pennsylvania, Puerto Rico, Tennessee, Texas and Washington named
- Medical device recall PHANTOM CS QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for… Lack of pouch seal. Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Hawaii, Illinois, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, Nevada, New York, Pennsylvania, Puerto Rico, Tennessee, Texas and Washington named
- Medical device recall PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for… Lack of pouch seal. Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Hawaii, Illinois, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, Nevada, New York, Pennsylvania, Puerto Rico, Tennessee, Texas and Washington named
- Medical device recall PHANTOM CS QUICK START DISTRACTION SCREW, 16 MM, STERILE, 5/BOX - Product Usage: intended to be used for… Lack of pouch seal. Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Hawaii, Illinois, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, Nevada, New York, Pennsylvania, Puerto Rico, Tennessee, Texas and Washington named
- Medical device recall Philips M3015A Microstream CO2 Extension Affected M3015A extensions are incompatible with the lntelliVue X3 Patient Monitor (Model No. Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Curaplex Ambu King LTS-D Supraglottic Airway Kit with ET Tube Kit contained an incorrect catheter-tip syringe not compatible with the luer lock connector of the included airway. Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RUSCH LASERTUBE (Rubber), RES 102004, Sizes: a) I.D Teleflex is initiating a voluntary recall for the above-mentioned products due to reports indicating that the laser guard foil partially separated and/or… Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a suturing needle for closing wounds… Tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure and result in in patient… Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereIllinois
- Medical device recall Pump Tube Set for MMS Libra and Solar Systems - Product Usage: Intended for use during water perfusion… This field correction is being initiated to address potentially damaged seals in the packaging of some the Laborie Pump Tube Sets. Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Florida, Indiana, Michigan, New Jersey, New York, Ohio, Oregon, Pennsylvania and Texas named
- Medical device recall The CapsoCam Plus (SV-3) Ingestible video capsule system has capsule with incorrect capture mode which will not record data when the capsule is ingested by patients. Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Delaware, Maryland, New Jersey, New York, South Carolina and Virginia named
- Medical device recall VistaSolution, physiological signal transmitter A healthcare provider (HCP) noticed a patient had a lowered historic SpO2 reading that the software should have triggered a notification to the care team, but… Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereNationwide, and New Jersey, New York and Virginia named
- Medical device recall OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrect size. Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrect size. Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate… An electrical sub-circuit was not properly connected. Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, North Carolina, Tennessee, Texas and Washington named
- Medical device recall TactiCath Quartz Contact Force Ablation Catheter High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz Contact Force Ablation Catheter Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ACTIV.A.C Therapy System The device may power off without notification to the user resulting in a stoppage of negative pressure wound therapy. Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Florida, Illinois, Maryland, North Dakota, Nevada, Ohio, Oklahoma, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usage: The systems are intended for… Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device. Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cardinal Health NPWT Occlusion Detection Canister 300cc, Prescription Only - Product Usage: The systems are… Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device. Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion DIFFICULT IV KIT containing BD’s Vacutainer Plastic Lithium Heparin Tubes (BD Vacutainer-BD Codes… False elevation of carboxyhemoglobin (COHb) results in blood samples collected using BD Vacutainer¿ Plastic Lithium Heparin tubes with the IL GEM 4000… Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereNationwide, and Illinois named
- Medical device recall Zenith Alpha Abdominal Endovascular Graft Identified products may contain a damaged bushing within the delivery system, which could potentially result in difficulty or an inability to fully deploy the… Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2 A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 8, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 8, 2020ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 SPANISH A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 8, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 8, 2020ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 8, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 8, 2020ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 8, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 8, 2020ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 8, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 8, 2020ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 8, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 8, 2020ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE DUTCH A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 8, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 8, 2020ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Arrow AutoCAT2 Intra-Aortic Balloon Pump AEROAUTOCAT 2 WAVE A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 8, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 8, 2020ClassClass IStatusTerminatedWhereNo state named
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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