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 7, 2026.
3,055of 3,055 medical device recallsshown with your filters
The list
- Medical device recall Bard Biopsy EnCor Probe, MRI, 10G Trocar Tip Lot numbers and products inadvertently not included in the scope of the previous recall. Class IIFDA’s classMar 11, 2020in FDA’s Enforcement Report30 statesnamed in where it went PublishedMar 11, 2020ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Virginia and West Virginia
- Medical device recall Bard Biopsy EnCor Probe, MRI, 10G Blunt Tip Lot numbers and products inadvertently not included in the scope of the previous recall. Class IIFDA’s classMar 11, 2020in FDA’s Enforcement Report30 statesnamed in where it went PublishedMar 11, 2020ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Virginia and West Virginia
- Medical device recall Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Version V1.21.0 and lower -… A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired. Class IIFDA’s classMar 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atellica IM Humidity Pack (Qty 1), SMN 11313496, UDI 00630414243726, Software Version V1.21.0 and lower -… A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired. Class IIFDA’s classMar 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Usage: The circuit is… Observed leakage at the sample port assembly which could potentially lead to loss of perfusion solution needed to maintain continuous machine perfusion. Class IIFDA’s classMar 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PTS Detect Cotinine, Ref The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance. Class IIFDA’s classMar 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall bellavista 1000 ventilator The G6 bellavista 1000 US ventilators may experience intermittent failures: Lack of acoustic high priority alarm, presence of a ‘no alarm’ condition, or… Class IIFDA’s classMar 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedMar 11, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Georgia, Illinois, Maryland, Michigan, Pennsylvania, Puerto Rico, Texas and Washington named
- Medical device recall Monitor for the Functional Imaging System for Magnetic Resonance Imaging System Insufficient shielding of Philips SensaVue DVI Adapter for computer monitor. Class IIFDA’s classMar 11, 2020in FDA’s Enforcement Report17 statesnamed in where it went PublishedMar 11, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, California, Colorado, Florida, Illinois, Indiana, Kentucky, Massachusetts, Michigan, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas and West Virginia
- Medical device recall SoundWave Professional Suite Software 3.2 The manufacturer received complaints that customers were attempting to install the fitting software using the supplied USB drive, an error message was… Class IIIFDA’s classMar 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedMar 11, 2020ClassClass IIIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont and Wisconsin named
- Medical device recall RespVent Closed Suction System T-Piece Tracheostomy Adult, Diameter: 4.6mm It has been determined that some units of catheters were not tightly connected to the thumb port. Class IIFDA’s classMar 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 11, 2020ClassClass IIStatusOngoingWhereNationwide, and California, New Jersey and New York named
- Medical device recall Elecsys CA 19-9 The firm has received an increased number of complaints concerning non-reproducible elevated results (“high flyers”) for one lot of Elecsys CA 19-9 reagent,… Class IIFDA’s classMar 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedMar 11, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Hawaii, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maine, Michigan, North Carolina, New Hampshire, New Jersey, New York, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Stryker Connected OR Cart,120 V There is a potential problem with firm s Connected OR Cart, 120V resulting in cart monitor not attaching flush with their monitor stow handle. Class IIFDA’s classMar 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 11, 2020ClassClass IIStatusTerminatedWhereNationwide, and Georgia and Texas named
- Medical device recall Covidien Force TriVerse Electrosurgical Devices, Product numbers FT3000 and FT3000DB, UDI 10884524000084… Sterile packaging may potentially be compromised, and use of products may result in increased risk for infection. Class IIFDA’s classMar 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Kits containing Covidien Force TriVerse Electrosurgical Devices Sterile packaging may potentially be compromised, and use of products may result in increased risk for infection. Class IIFDA’s classMar 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall FilmArray NGDS Warrior Panel The firm has identified that an incorrect instruction for use (IFU) revision was included in the qualitative, multiplexed, nucleic acid-based in vitro… Class IIIFDA’s classMar 11, 2020in FDA’s Enforcement Report6 statesnamed in where it went PublishedMar 11, 2020ClassClass IIIStatusTerminatedWhereColorado, Georgia, Maryland, Ohio, Texas and Utah
- Medical device recall Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx… M4758A Ambulance Parameter Extension (APE) kit may cause ECG “Leads Off” condition in hot, humid environments Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Selenia Dimensions Mammography System The recalling firm has received reports from the field of the C-arm on the Selenia Dimensions system seizing or dropping during field repairs and cleaning of… Class IIFDA’s classMar 4, 2020in FDA’s Enforcement Report21 statesnamed in where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereAlaska, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Massachusetts, Missouri, North Carolina, New Hampshire, New Jersey, New York, Ohio, South Dakota, Texas and Virginia
- Medical device recall Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2 if an AAA battery is inserted in the recorder and a user attempts to start it, or if the recorder is inserted in the docking station, the recorder will display… Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall COHERENCE Oncologist A potential safety issue arises when an offset calculation is followed by a filter operation; correcting the image alignment after this sequence will result in… Class IIFDA’s classMar 4, 2020in FDA’s Enforcement Report16 statesnamed in where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Iowa, Massachusetts, Michigan, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee and West Virginia
- Medical device recall THP Hip Plating System Potential increase in fracture rate was detected during internal testing, in addition to potential discoloration inside the inner pouch of the packaging. Class IIFDA’s classMar 4, 2020in FDA’s Enforcement Report20 statesnamed in where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Pennsylvania, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall TLC-2000 Therapeutic Medical Laser System Power Pack Power Pack (component) was shipped with an internal battery pack tested to UN-38.3, UL-2054 and IEC-62133 (2nd Edition) standards; however, not tested to… Class IIIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 4, 2020ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall RX Daytona Plus (with ISE/without ISE) Software version UI2550642107 for the RX Daytona + instrument released to correct the following issues: 1) The order of samples displayed is not sequential… Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Ulrich medical neon3 OCT spinal stabilization Due to a production error, the weld seam of the “Locking screw for crosslink, screw-to-screw” cannot reliably transmit the required torque of 3.5 Nm during… Class IIFDA’s classMar 4, 2020in FDA’s Enforcement Report6 statesnamed in where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Georgia and Texas
- Medical device recall Ellipse, Tiered-therapy Cardioverter/Defibrillator Past updates to programmers and transmitters may lead some implantable cardioverter defibrillators (ICD) to lose wireless radiofrequency (RF) communication;… Class IIFDA’s classMar 4, 2020in FDA’s Enforcement Report19 statesnamed in where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereArizona, California, Delaware, Florida, Indiana, Kentucky, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Texas, Washington and West Virginia
- Medical device recall Protective Cover Vivo 55/65 (Used for Vivo 50/65) The outlet hole of the exhalation valve control pressure tube on the ventilator may become obstructed by the protective cover. Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Florida, Georgia, Iowa, Illinois, Kansas, Massachusetts, Michigan, Missouri, New Jersey, New York, Ohio, Puerto Rico, South Carolina, Texas, Virginia and Wisconsin named
- Medical device recall TLC-2000 Therapeutic Medical Laser System 660 nm laser diodes may be below rated power output. Class IIIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 4, 2020ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall TLC-2000 Therapeutic Medical Laser System 905 nm laser diodes may be below rated power output. Class IIIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 4, 2020ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall Zenith Alpha Spiral-Z Endovascular Leg The firm has identified factors which contributed to failures relating to thrombus formation and/or lumen occlusion reports, and is highlighting to customers… Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port, Dual Bladder When inflating/deflating a single bladder, both bladders could potentially inflate/deflate due to a leak between the bladders. Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Iowa, Idaho, Illinois, Louisiana, Massachusetts, Missouri, North Carolina, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall Medline HOI LUMBAR The sterile pack inside the Complete Delivery System (CDS) did not go through a complete sterilization cycle, therefore the sterility of these components… Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall Medline ROBOTIC-LF The sterile pack inside the Complete Delivery System (CDS) did not go through a complete sterilization cycle, therefore the sterility of these components… Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall ADVIA Chemistry Lipase, Ref Firm has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using this product. Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Florida, Georgia, Iowa, Kansas, Maryland, Michigan, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas and Washington named
- Medical device recall Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee… These Truliant Splined Stem Extension, 18mm x 120mm were found to have a labeling error. Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 4, 2020ClassClass IIStatusOngoingWhereNationwide, and Arizona, Colorado and Florida named
- Medical device recall NUCLISENS¿ Lysis Buffer, IVD Following a customer complaint about colored eluates, leading to invalid results bioMerieux has confirmed an issue with NUCLISENS Lysis Buffer, ref. Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 3MM(H) Reference Number: IEHA343 Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin… Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CERTAIN¿ BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 4MM(H) Reference Number: IEHA344 Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin… Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 6MM(H) Reference Number: IEHA346 Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin… Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA353 Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin… Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 4MM(H) Reference Number: IEHA354 Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin… Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA356 Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin… Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 3MM(H) Reference Number: IEHA443 Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin… Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 4MM(H) Reference Number: IEHA444 Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin… Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 6MM(H) Reference Number: IEHA446 Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin… Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA453 Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin… Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H) Reference Number: IEHA454 Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin… Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA456 Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin… Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA463 Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin… Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA464 Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin… Class IIFDA’s classMar 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2020ClassClass IIStatusTerminatedWhereNationwide
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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