Medical devices, 2021
Shortlist up to four to read them side by side.
2,303 medical device recalls FDA’s Enforcement Report published in 2021, 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 5, 2026.
2,303of 2,303 medical device recallsshown with your filters
The list
- Medical device recall LEEP PRECISION Integrated System, 120V CooperSurgical Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring… Class IIFDA’s classNov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 24, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LEEP PRECISION Integrated System, 220V CooperSurgical Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring… Class IIFDA’s classNov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 24, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LEEP PRECISION Generator 120V Cooper Surgical Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring… Class IIFDA’s classNov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 24, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LEEP PRECISION Generator 220V Cooper Surgical Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring… Class IIFDA’s classNov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 24, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Quantum 2000 Electrosurgical Generators Cooper Surgical Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring… Class IIFDA’s classNov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 24, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Quantum 2000 Electrosurgical Generators Cooper Surgical Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring… Class IIFDA’s classNov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 24, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Quantum 2000 Electrosurgical Generators Cooper Surgical XXX Class IIFDA’s classNov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 24, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Permobil TiLite, Models: Aero Z, and ZRA Some affected wheelchairs, with transit tie downs, that are used as a passenger seat in a motor vehicle may not be configured in the right orientation to… Class IIFDA’s classNov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedNov 24, 2021ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Smith and Nephew EVOS Self-Tapping Locking Screw SST The labels on the packages of screws were switched. Class IIFDA’s classNov 24, 2021in FDA’s Enforcement Report25 statesnamed in where it went PublishedNov 24, 2021ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas and Washington
- Medical device recall Cobas u 601 urinalysis test system A potential risk for false negative nitrite results exists when endogenous creatinine levels are 15,000 mg/L and above. Class IIFDA’s classNov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 24, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ellume COVID-19 Home Test Due to a higher rate of false positive test results. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 17, 2021in FDA’s Enforcement Report6 statesnamed in where it went PublishedNov 17, 2021ClassClass IStatusOngoingWhereMinnesota, New York, Pennsylvania, Rhode Island, Utah and Washington
- Medical device recall McKesson PREVENT HT Safety Blood Collection Needles, 21G 1 1/4 inch, MFR # 16-NBC21GS Potential for difficulty in safety mechanism activation. Class IIFDA’s classNov 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall McKesson PREVENT HT Safety Blood Collection Needles, 22G 1 1/4 inch, MFR # 16-NBC22GS Potential for difficulty in safety mechanism activation. Class IIFDA’s classNov 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, MFR # 16-NBCH22GS Potential for difficulty in safety mechanism activation. Class IIFDA’s classNov 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, MFR # 16-NBCH21GS Potential for difficulty in safety mechanism activation. Class IIFDA’s classNov 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall HENRY SCHEIN Safety Blood Collection Needle 21Gx 1 1/4 Inch Potential for difficulty in safety mechanism activation. Class IIFDA’s classNov 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall HENRY SCHEIN Safety Blood Collection Needle 22Gx 1 1/4 Inch Potential for difficulty in safety mechanism activation. Class IIFDA’s classNov 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1 The firm identified an error in the device temperature monitoring circuitry which is designed to interrupt energy delivery in the event of a primary cooling… Class IIFDA’s classNov 17, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 17, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Lack of Packaging seal integrity may result in a sterile barrier breach. Class IIFDA’s classNov 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 17, 2021ClassClass IIStatusTerminatedWhereNationwide, and North Carolina named
- Medical device recall THERAKOS CELLEX Photopheresis Procedural Kit Product was released prior to all testing being completed. Class IIFDA’s classNov 17, 2021in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedNov 17, 2021ClassClass IIStatusOngoingWhereIllinois
- Medical device recall Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x When the user presses or releases both the APC (accept) button and the Float Tabletop (panning) button at the same time, the geometry may stop reacting on… Class IIFDA’s classNov 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only This product s intended use is… Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls. Class IIFDA’s classNov 17, 2021in FDA’s Enforcement Report5 statesnamed in where it went PublishedNov 17, 2021ClassClass IIStatusTerminatedWhereCalifornia, Florida, Michigan, New Jersey and Ohio
- Medical device recall Hemodialysis Delivery System, Software Version 2.x. If the operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the Same… Class IIFDA’s classNov 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 17, 2021ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL Monoject 0.9% Sodium Chloride Flush Syringe Manufactured by Cardinal Health and placed into kits. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 10, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 10, 2021ClassClass IStatusOngoingWhereFlorida and Pennsylvania
- Medical device recall FIVE S 3.5x65, Flexible Intubation Videoscope During a regular requalification review, affected flexible intubation video endoscopes did not achieve the required sterility assurance level. Class IIFDA’s classNov 10, 2021in FDA’s Enforcement Report40 statesnamed in where it went PublishedNov 10, 2021ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908 The introducer sheath… Affected lots may be manufactured incorrectly with the radiopaque marker band located just below the Check-Flo proximal fitting instead of the distal tip. Class IIFDA’s classNov 10, 2021in FDA’s Enforcement Report17 statesnamed in where it went PublishedNov 10, 2021ClassClass IIStatusTerminatedWhereArkansas, Arizona, Connecticut, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maine, Minnesota, North Dakota, New Jersey, New York, Ohio, Pennsylvania, Texas and Washington
- Medical device recall Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069 The… Affected lots may be manufactured incorrectly with the radiopaque marker band located just below the Check-Flo proximal fitting instead of the distal tip. Class IIFDA’s classNov 10, 2021in FDA’s Enforcement Report17 statesnamed in where it went PublishedNov 10, 2021ClassClass IIStatusTerminatedWhereArkansas, Arizona, Connecticut, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maine, Minnesota, North Dakota, New Jersey, New York, Ohio, Pennsylvania, Texas and Washington
- Medical device recall COVENA PICC Sleeve Marketed without FDA clearance Class IIFDA’s classNov 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 10, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape Potential for breakage of the ECG electrode carbon stud from the eyelet. Class IIFDA’s classNov 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedNov 10, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Iowa, Illinois, Louisiana, Maryland, Missouri, North Carolina, New Jersey and Ohio named
- Medical device recall Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3 Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the… Class IIFDA’s classNov 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 10, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3 Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the… Class IIFDA’s classNov 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 10, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3 Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the… Class IIFDA’s classNov 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 10, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0 When the ultrasound system is used in combination with a Fujifilm (formally Hitachi) transducer, there is an error in the calculation formula of Effective… Class IIFDA’s classNov 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 10, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Aptio Automation Interface Module to ADVIA Centaur XP/XPT The Aptio Automation Firmware for the ADVIA Centaur XP/XPT Interface Module may lead, in some cases, to an incorrect association of test results to sample ID. Class IIFDA’s classNov 10, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 10, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063) Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedNov 10, 2021ClassClass IStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Atellica IM SARS-CoV-2 Antigen Assay Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use. Class IIFDA’s classNov 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedNov 10, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, Colorado, District of Columbia, Georgia, Illinois, Maine, North Carolina, Nevada, New York, Oregon, Pennsylvania, Puerto Rico, Virginia and US Virgin Islands named
- Medical device recall ADVIA Centaur SARS-CoV-2 Antigen Assay Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use. Class IIFDA’s classNov 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedNov 10, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, Colorado, District of Columbia, Georgia, Illinois, Maine, North Carolina, Nevada, New York, Oregon, Pennsylvania, Puerto Rico, Virginia and US Virgin Islands named
- Medical device recall ImplantDirect Packaged dental implant contains a different size then the size declared on the labeling. Class IIFDA’s classNov 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedNov 10, 2021ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Hawaii, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Montana, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall ImplantDirect Packaged dental implant contains a different size then the size declared on the labeling. Class IIFDA’s classNov 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedNov 10, 2021ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Hawaii, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Montana, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear… Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR) Class IIFDA’s classNov 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 10, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following… Software error, the software can produce an incorrect interpretation of the table rotation if the table has been rotated by more than 4degrees in either… Class IIFDA’s classNov 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 10, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Clinician Programmer Application (CPA) A software anomaly may occur with the clinician programmer application. Class IIFDA’s classNov 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 10, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Aspiration Syringe Kit Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers. Class IIFDA’s classNov 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedNov 10, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Nevada and New York named
- Medical device recall GM Helix Acqua Implant 3.5x10, Article No. 140.944 3.5x11.5mm implants were mislabeled as 3.5x10mm implants. Class IIFDA’s classNov 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 10, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RAPTAR Laser Range Finders RAPTAR units are capable of being field modified to enable the use of the higher power visible and IR laser pointers and the IR Illuminator. Class IIFDA’s classNov 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 3, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of… The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which led to the inaccurate placement of an electrode during surgery. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 3, 2021ClassClass IStatusOngoingWhereNationwide
- Medical device recall Pneupac paraPac plus 300 ventilator kit Two devices were labeled with the same serial number Class IIIFDA’s classNov 3, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 3, 2021ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm,… Septal Occluders contain the incorrect expiration date. Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report47 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
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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