Medical devices, 2019
Shortlist up to four to read them side by side.
2,801 medical device recalls FDA’s Enforcement Report published in 2019, 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.
2,801of 2,801 medical device recallsshown with your filters
The list
- Medical device recall SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product Usage: This device is intended to be… In these units, the brake is usually released by gripping the drive handle and applied by letting go of the handle. Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is intended to be used to take a film,… FUJIFILM Medical Systems U.S.A., Inc., Modality Systems became aware of the possibility that the braking mechanism might not be engaged in all cases when the… Class IIFDA’s classMar 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364 The products were manufactured without a back bevel on the needle tip. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedMar 20, 2019ClassClass IStatusTerminatedWhereNationwide, and Arizona, Florida, Illinois, Indiana, Kansas, Massachusetts, Michigan, Missouri, Pennsylvania, South Carolina, Tennessee and Washington named
- Medical device recall AVE 2 Birthing Bed LINET has recently become aware of a potential safety issue for the AVE 2 Birthing Bed caused by the power cable breaking at the bed connection or the orange… Class IIFDA’s classMar 20, 2019in FDA’s Enforcement Report21 statesnamed in where it went PublishedMar 20, 2019ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Illinois, Kansas, Kentucky, Louisiana, Minnesota, Missouri, New Jersey, Ohio, Oklahoma, Oregon, Tennessee, Texas, Utah and Washington
- Medical device recall VITROS Chemistry Products Na+ Slides Imprecision in the affected lot may produce negatively or positively biased patient sample and quality control fluid results. Class IIFDA’s classMar 20, 2019in FDA’s Enforcement Report20 statesnamed in where it went PublishedMar 20, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Florida, Hawaii, Iowa, Idaho, Illinois, Louisiana, Michigan, Missouri, Mississippi, North Carolina, New Mexico, New York, Oklahoma, Pennsylvania, Texas, West Virginia and Wyoming
- Medical device recall Durex Real Feel, synthetic polisoprene male condom Five batches of the product have failed the specification of 1.0kPa for Burst Pressure. Class IIFDA’s classMar 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 20, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Durex Pleasure Pack Five batches of the product have failed the specification of 1.0kPa for Burst Pressure. Class IIFDA’s classMar 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 20, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AMSCO 3000 Series Washer/Disinfector The software in the systems may not process the cycle originally intended. Class IIFDA’s classMar 20, 2019in FDA’s Enforcement Report27 statesnamed in where it went PublishedMar 20, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Colorado, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Maine, Michigan, North Carolina, New Jersey, New Mexico, New York, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall AMSCO 5000 Series Washer/Disinfector The software in the systems may not process the cycle originally intended. Class IIFDA’s classMar 20, 2019in FDA’s Enforcement Report27 statesnamed in where it went PublishedMar 20, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Colorado, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Maine, Michigan, North Carolina, New Jersey, New Mexico, New York, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Ossur Skull Pin, Sterile Titanium Pin, Part/Description: 516TS/ Skull Pin 2-1/4in TI Sterl 1PK Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. Class IIFDA’s classMar 20, 2019in FDA’s Enforcement Report28 statesnamed in where it went PublishedMar 20, 2019ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Mexico, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington
- Medical device recall Ossur Skull Pin, Sterile Ceramic Tip Pin, Part/ Description: 516CS/ Skull Pin 2-1/4in CT Sterl 1PK Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. Class IIFDA’s classMar 20, 2019in FDA’s Enforcement Report28 statesnamed in where it went PublishedMar 20, 2019ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Mexico, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington
- Medical device recall Ossur OB Resolve, Sterile, Part/ Description: 505300D/ OB RESOLVE STERILE RING SML Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. Class IIFDA’s classMar 20, 2019in FDA’s Enforcement Report28 statesnamed in where it went PublishedMar 20, 2019ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Mexico, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington
- Medical device recall Ossur CB Resolve, Sterile, Part/ Description: 505300C/ CB RESOLVE STERILE UNIT SML Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. Class IIFDA’s classMar 20, 2019in FDA’s Enforcement Report28 statesnamed in where it went PublishedMar 20, 2019ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Mexico, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington
- Medical device recall Ossur, Sterile, Part/ Description: 505300T/ CB RING KIT TI SM Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. Class IIFDA’s classMar 20, 2019in FDA’s Enforcement Report28 statesnamed in where it went PublishedMar 20, 2019ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Mexico, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington
- Medical device recall Ossur, J Tong, Sterile, Part/ Description: JT-115/ J TONG MED/LGE-No App Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. Class IIFDA’s classMar 20, 2019in FDA’s Enforcement Report28 statesnamed in where it went PublishedMar 20, 2019ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Mexico, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington
- Medical device recall Ossur, ReSolve Halo Vest, Part/ Description: 545700K/ ReSolve Halo Vest-shrt kodel Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. Class IIFDA’s classMar 20, 2019in FDA’s Enforcement Report28 statesnamed in where it went PublishedMar 20, 2019ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Mexico, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington
- Medical device recall Ossur, LIL Angel Vest, Part/ Description: 545100K/ LIL ANGEL VEST P2 KODEL Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. Class IIFDA’s classMar 20, 2019in FDA’s Enforcement Report28 statesnamed in where it went PublishedMar 20, 2019ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Mexico, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington
- Medical device recall NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, Size 4 5MM Thickness W/Screws Potentially comingled, resulting in the product in the box potentially not matching the product on the label Class IIFDA’s classMar 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedMar 20, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Idaho, Mississippi, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia and Wisconsin named
- Medical device recall NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Size 4 5MM Thickness W/Screws Potentially comingled, resulting in the product in the box potentially not matching the product on the label Class IIFDA’s classMar 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedMar 20, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Idaho, Mississippi, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia and Wisconsin named
- Medical device recall Olympus GF-UCT180 Ultrasound Gastrovideoscope - Product Usage: These endoscopes are intended for use in… The adhesive used in the repair of the endoscope was incorrectly prepared. Class IIFDA’s classMar 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedMar 20, 2019ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Illinois, Minnesota, Missouri and North Carolina named
- Medical device recall Olympus GIF-H180J Gastrointestinal Videoscope - Product Usage: These endoscopes are intended for use in… The adhesive used in the repair of the endoscope was incorrectly prepared. Class IIFDA’s classMar 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedMar 20, 2019ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Illinois, Minnesota, Missouri and North Carolina named
- Medical device recall Olympus PCF-Q180AC Video Colonoscope - Product Usage: These endoscopes are intended for use in endoscopic… The adhesive used in the repair of the endoscope was incorrectly prepared. Class IIFDA’s classMar 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedMar 20, 2019ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Illinois, Minnesota, Missouri and North Carolina named
- Medical device recall Olympus TJF-Q180V Duodenoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis… The adhesive used in the repair of the endoscope was incorrectly prepared. Class IIFDA’s classMar 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedMar 20, 2019ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Illinois, Minnesota, Missouri and North Carolina named
- Medical device recall US Endoscopy Padlock Clip defect closure system Potential esophageal laceration during a patient procedure Class IIFDA’s classMar 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 20, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Flexima Duodenal Bend Biliary Stent with Delivery System, 7F The sterile barrier may contain packaging seal defects. Class IIFDA’s classMar 20, 2019in FDA’s Enforcement Report9 statesnamed in where it went PublishedMar 20, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Illinois, Maryland, Pennsylvania, Tennessee, Texas, Utah and Wisconsin
- Medical device recall Flexima Duodenal Bend Biliary Stent with Delivery System, 7F The sterile barrier may contain packaging seal defects. Class IIFDA’s classMar 20, 2019in FDA’s Enforcement Report9 statesnamed in where it went PublishedMar 20, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Illinois, Maryland, Pennsylvania, Tennessee, Texas, Utah and Wisconsin
- Medical device recall Raindrop Near Vision Inlay During a post approval study the firm found there was an increased risk of corneal haze following the implantation of this device. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 13, 2019in FDA’s Enforcement Report37 statesnamed in where it went PublishedMar 13, 2019ClassClass IStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall C2 CryoBalloon Controller The Controller does not detect overpressure in the balloon during the application of non-dosing puffs of Nitrous Oxide, which can contribute to balloon over… Class IIFDA’s classMar 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedMar 13, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, District of Columbia, Florida, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Washington named
- Medical device recall ARCHITECT MAGNESIUM, (a) Abbott internal testing has identified that the Magnesium urine application demonstrates depressed urine result recovery. Class IIFDA’s classMar 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper Adapter The product was potentially being packaged without a taper adapter. Class IIFDA’s classMar 13, 2019in FDA’s Enforcement Report3 statesnamed in where it went PublishedMar 13, 2019ClassClass IIStatusTerminatedWhereArkansas, Kentucky and Washington
- Medical device recall Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to… Affected lots of reprocessed arthroscopic shavers may display the incorrect catalog number and speed settings when connected to the generator, require manual… Class IIFDA’s classMar 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedMar 13, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended… The firm is recalling their Delta family of patient monitors software due to cybersecurity vulnerabilities, which may cause the device to reboot, lose… Class IIFDA’s classMar 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 13, 2019ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Omega Systems These devices are intended to be used in the environment where patient care is provided by… The firm is recalling their Delta family of patient monitors software due to cybersecurity vulnerabilities, which may cause the device to reboot, lose… Class IIFDA’s classMar 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 13, 2019ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Instrument Tray, Basic T2 Femur Long The faceplates may incorrectly identify the T2 Basic Long Instrument Set as T2 Basic Short Instrument Set. Class IIFDA’s classMar 13, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 13, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use with the BD MAX System False negative results with the BD MAX Extended Enteric Bacterial Panel when testing specifically for Enterotoxigenic Escherichia coli (ETEC) and Plesiomonas… Class IIFDA’s classMar 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedMar 13, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Georgia, Hawaii, Idaho, Michigan, Minnesota, Montana, New Jersey, New Mexico, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Vermont and Washington named
- Medical device recall Cepheid Respiratory Control Panel Cepheid Xpert Respiratory Control Panel (Catalog #8199) has an reduced expiration date from 24 months to 13 months. Class IIFDA’s classMar 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedMar 13, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall AXIUS Blower Mister Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB). Class IIFDA’s classMar 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Uroskop Omnia -fluoroscopic X-ray system The swivel arm holding the monitors may become dislodged from the carrying arm. Class IIFDA’s classMar 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Uroskop Omnia Max -fluoroscopic X-ray system The swivel arm holding the monitors may become dislodged from the carrying arm. Class IIFDA’s classMar 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet XS Flat Screen Monitor Holder, XS32 SPE, Configuration The affected flat screen monitor holders might not be compliant with grounding requirements. Class IIFDA’s classMar 13, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 13, 2019ClassClass IIStatusTerminatedWhereArizona and Texas
- Medical device recall Maquet XS Flat Screen Monitor Holder, PWD50+DF XS32 K3 SPE, Configuration The affected flat screen monitor holders might not be compliant with grounding requirements. Class IIFDA’s classMar 13, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 13, 2019ClassClass IIStatusTerminatedWhereArizona and Texas
- Medical device recall Maquet XS Flat Screen Monitor Holder, PWD70+DF HD R XS32 K3 SPE, Configuration The affected flat screen monitor holders might not be compliant with grounding requirements. Class IIFDA’s classMar 13, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 13, 2019ClassClass IIStatusTerminatedWhereArizona and Texas
- Medical device recall Maquet XS Flat Screen Monitor Holder, SAT XS32 12 SPE, Configuration The affected flat screen monitor holders might not be compliant with grounding requirements. Class IIFDA’s classMar 13, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 13, 2019ClassClass IIStatusTerminatedWhereArizona and Texas
- Medical device recall icumedical ChemoLock Vial Spike, 20mm There is a potential for one lot of ChemoLock Vial Spike to contain burr particulate FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2019in FDA’s Enforcement Report7 statesnamed in where it went PublishedMar 6, 2019ClassClass IStatusTerminatedWhereCalifornia, Florida, Iowa, Illinois, Ohio, Pennsylvania and Virginia
- Medical device recall LIFEPAK 15 Monitor/Defibrillator Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete… Certain LIFEPAK 15 Monitors/ Defibrillators were reported to experience a lockup condition after a shock was delivered. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 6, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall LIFEPAK 15 Monitor/Defibrillator service kits Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15)… Certain LIFEPAK 15 Monitors/ Defibrillators were reported to experience a lockup condition after a shock was delivered. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 6, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Vitality¿ Spinal Fixation System The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing… Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Vitality¿ Spinal Fixation System The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing… Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Washington and Wisconsin 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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