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 5, 2026.
3,055of 3,055 medical device recallsshown with your filters
The list
- Medical device recall Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who… Potential increased occurrence of pump fracture over the lifetime of the device. Class IIFDA’s classDec 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedDec 2, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Box Label: ION Fully Articulating Catheter The distal tip ring of the fully articulating catheter may become dislodged during the procedure. Class IIFDA’s classDec 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedDec 2, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, District of Columbia, Florida, Iowa, Illinois, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Virginia named
- Medical device recall Geistlich Bio-Oss Pen 0.25-1mm 0.25g - Product Usage: natural bone mineral for filling of bone defects in… Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules may be expelled all at once, causing surrounding… Class IIFDA’s classDec 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 2, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Geistlich Bio-Oss Pen 0.25-1mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in… Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules may be expelled all at once, causing surrounding… Class IIFDA’s classDec 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 2, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Geistlich Bio-Oss Pen 1-2mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in… Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules may be expelled all at once, causing surrounding… Class IIFDA’s classDec 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 2, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cardioblate CryoFlex, Surgical Ablation Probe There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices Class IIFDA’s classDec 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 2, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cardioblate CryoFlex, Surgical Ablation Probe There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices Class IIFDA’s classDec 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 2, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cardioblate CryoFlex, Surgical Ablation Probe There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices Class IIFDA’s classDec 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 2, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cardioblate CryoFlex, Surgical Ablation Probe There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices Class IIFDA’s classDec 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 2, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038-990-075U/ 7.5, 038-990-070U/… When the video stylet cuff is over-inflated there is potential for occlusion of the corrugated section of the ETT, and increased resistance to gas flow and… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 2, 2020ClassClass IStatusTerminatedWhereNationwide
- Medical device recall COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study. Class IIFDA’s classNov 25, 2020in FDA’s Enforcement Report48 statesnamed in where it went PublishedNov 25, 2020ClassClass IIStatusOngoingWhereAlabama, 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, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Class IV New Era medical laser device The firm failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with the laser product… Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall v|tome|x L Series non-destructive testing cabinet x-ray systems It was discovered during testing of the v/tome/x L450 system s/n PA1790, that the pre-warning signals does not provide “Audible and visible warning signals… Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 25, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection. The firm is replacing all tubes that were manufactured and distributed prior to Enforcement Discretion Approval. Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedNov 25, 2020ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid… Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and decreased… Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For use in monitoring the… Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and decreased… Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Kangaroo Connect 500ml Bag Set, Non-Sterile The feeding spike sets may leak at the interface of the tube and spike connector. Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Kangaroo Connect 1000ml Bag Set, Non-Sterile The feeding spike sets may leak at the interface of the tube and spike connector. Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample collection. Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Merit Medical Cultura Collection and Transport System The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample collection. Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Merit Medical Cultura Collection and Transport System, 3 mL Viral Transport Medium The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample collection. Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Osteosynthesis Compression Staple EasyClip The device has the potential to release nickel above the acceptable margin of safety in pediatric patients who weigh less than 20 kg (44.09 lbs) when 2 or more… Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist… Potential for cleaning solution intrusion into endoscope Class IIIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium The product may be mislabeled. Class IIFDA’s classNov 25, 2020in FDA’s Enforcement Report21 statesnamed in where it went PublishedNov 25, 2020ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Illinois, Indiana, Kentucky, Louisiana, Maryland, Maine, Minnesota, Nevada, New York, Ohio, Oklahoma, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium The product may be mislabeled. Class IIFDA’s classNov 25, 2020in FDA’s Enforcement Report21 statesnamed in where it went PublishedNov 25, 2020ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Illinois, Indiana, Kentucky, Louisiana, Maryland, Maine, Minnesota, Nevada, New York, Ohio, Oklahoma, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is… Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expiration Control Rule Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VNS Therapy¿ AspireSR¿ Generator Due to an extra digit being inadvertently added to the serial number of a subset of implantable pulse generators, they become not compatible with therapy… Class IIFDA’s classNov 25, 2020in FDA’s Enforcement Report29 statesnamed in where it went PublishedNov 25, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Colorado, District of Columbia, Florida, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, Nevada, Oklahoma, Oregon, Puerto Rico, Texas, Utah, Virginia and Washington
- Medical device recall MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior… Tightening the LIGAPASS Band with this instrument, the tensioner’s pliers can crush the band causing the band to break during surgery and lead to a risk of… Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedNov 25, 2020ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall Alpen Clinic 100 Carbide Instruments (R100057C) The FG 557 bur was incorrectly packaged as the FG 57 bur. Class IIFDA’s classNov 25, 2020in FDA’s Enforcement Report5 statesnamed in where it went PublishedNov 25, 2020ClassClass IIStatusOngoingWhereFlorida, Nevada, Pennsylvania, Tennessee and Texas
- Medical device recall FG 57 100057X The FG 557 bur was incorrectly packaged as the FG 57 bur. Class IIFDA’s classNov 25, 2020in FDA’s Enforcement Report5 statesnamed in where it went PublishedNov 25, 2020ClassClass IIStatusOngoingWhereFlorida, Nevada, Pennsylvania, Tennessee and Texas
- Medical device recall Clinic Pack 100 Pieces FG 57 100057C The FG 557 bur was incorrectly packaged as the FG 57 bur. Class IIFDA’s classNov 25, 2020in FDA’s Enforcement Report5 statesnamed in where it went PublishedNov 25, 2020ClassClass IIStatusOngoingWhereFlorida, Nevada, Pennsylvania, Tennessee and Texas
- Medical device recall CEI Cutting Edge Instruments (PTC-57C) The FG 557 bur was incorrectly packaged as the FG 57 bur. Class IIFDA’s classNov 25, 2020in FDA’s Enforcement Report5 statesnamed in where it went PublishedNov 25, 2020ClassClass IIStatusOngoingWhereFlorida, Nevada, Pennsylvania, Tennessee and Texas
- Medical device recall Strauss 25 Carbide Dental Burs The FG 557 bur was incorrectly packaged as the FG 57 bur. Class IIFDA’s classNov 25, 2020in FDA’s Enforcement Report5 statesnamed in where it went PublishedNov 25, 2020ClassClass IIStatusOngoingWhereFlorida, Nevada, Pennsylvania, Tennessee and Texas
- Medical device recall Artis zee floor, Artis Q ceiling, Artis Q.zen ceiling Some electronic components within the generator were equipped with an incorrect protection diode. Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedNov 25, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Iowa and Illinois named
- Medical device recall Elastic Traction Device, 11mm Lower FDA has informed Micro-Tech that the Elastic Traction Device is not appropriately classified as a Class I device and requires 510(k) clearance to be marketed… Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedNov 25, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Illinois, Massachusetts, Michigan, New York, Ohio, Puerto Rico, Texas and Virginia named
- Medical device recall VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products… Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated… Class IIIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2020ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall Mako Integrated Cutting System (MICS) Handpiece Stryker has discovered a characterization issue associated with the Mako Integrated Cutting System (MICS) Handpiece. Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2020ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Atellica IM 1300 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro… Test Definition scanning may reset custom settings to defaults causing falsely low or high results. Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atellica IM 1600 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro… Test Definition scanning may reset custom settings to defaults. Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on patient population sizes from… In-house lab observations and customer reports of overheating and/or thermal damage to the battery pack, create the risk of exposure to smoke or hazardous… Class IIFDA’s classNov 18, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 18, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EDI Novel Coronavirus COVID-19 IgG ELISA Kit The use of deionized water rather than distilled water during the manufacturing process, may have resulted in accelerated decreased OD signals for the Positive… Class IIFDA’s classNov 18, 2020in FDA’s Enforcement Report20 statesnamed in where it went PublishedNov 18, 2020ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Hawaii, Illinois, Massachusetts, Maryland, Michigan, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas and Virginia
- Medical device recall AMS 700 MS Pump with and without InhibiZone The recalling firm has observed an increase in complaints of problems encountered during the initial activation of the device in which the patient and/or the… Class IIFDA’s classNov 18, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 18, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall QUIDEL Sofia SARS Antigen FIA IVD Due to false positive results. Class IIFDA’s classNov 18, 2020in FDA’s Enforcement Report23 statesnamed in where it went PublishedNov 18, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Florida, Georgia, Indiana, Louisiana, Missouri, Mississippi, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall XTANT Medical, ## mm x ## mm x # mm x # ,Lordotic/Packaged InTice - C, Sterile R, Single Use Only, for the… Cervical Implants contain a label that incorrectly identifies the grade of titanium used. Class IIIFDA’s classNov 18, 2020in FDA’s Enforcement Report5 statesnamed in where it went PublishedNov 18, 2020ClassClass IIIStatusTerminatedWhereArizona, California, Florida, Ohio and Texas
- Medical device recall Niobe ES System, Models 001-006000-1 and 001-006100-1 There is a potential for fire in the inside computer cabinet. Class IIFDA’s classNov 18, 2020in FDA’s Enforcement Report28 statesnamed in where it went PublishedNov 18, 2020ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Washington and Wisconsin
- Medical device recall Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory… Potential for the inner bit to contain a crack, that may or may not be visible, which may lead to metal fragments entering the surgical site and/or delayed… Class IIFDA’s classNov 18, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 18, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall FlexLab (FLX) Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator… When a Clot Detection Error is generated during the sample aspiration from the Primary Sample Tube the aspirated volume is dispensed into the first empty… Class IIFDA’s classNov 18, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 18, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Accelerator a3600 Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka… When a Clot Detection Error is generated during the sample aspiration from the Primary Sample Tube the aspirated volume is dispensed into the first empty… Class IIFDA’s classNov 18, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 18, 2020ClassClass IIStatusTerminatedWhereNo 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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