Medical devices, 2022
Shortlist up to four to read them side by side.
2,192 medical device recalls FDA’s Enforcement Report published in 2022, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
2,192of 2,192 medical device recallsshown with your filters
The list
- Medical device recall AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended for use with hemodialysis systems Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured Class IIFDA’s classSep 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedSep 28, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, District of Columbia, Florida, Georgia, Indiana, Massachusetts, Nevada, New York, Pennsylvania and Texas named
- Medical device recall Diversatek Health, M-Catch Retrieval Nets M-Catch Retrieval Nets, Part Number 1175-01 / Lot Number 001919, that were shipped between 9-27-2021 and 10-22-2021, may contain incorrect inner polybag… Class IIFDA’s classSep 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 28, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2,… ***Update** :HBsAg analyte is also Non-Reactive on the Ortho Vitros analyser as well as the Beckman Coulter DxI. Class IIFDA’s classSep 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 28, 2022ClassClass IIStatusTerminatedWhereNationwide, and North Carolina and West Virginia named
- Medical device recall PDS II (polydioxanone) Suture Product may contain the incorrect material which could impact treatment. Class IIFDA’s classSep 28, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 28, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Fungitell STAT- IVD Assay for Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to printed information for reconstitution and… Class IIFDA’s classSep 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 28, 2022ClassClass IIStatusTerminatedWhereNationwide, and California named
- Medical device recall Puritan Bennett 560 Ventilator, PB560, CFN 4096600 Medtronic has confirmed six reports from customers outside the US where the ventilator became inoperable due to loss of gas supply caused by manufacturing… Class IIFDA’s classSep 28, 2022in FDA’s Enforcement ReportDistrict of Columbiathe one state its words name PublishedSep 28, 2022ClassClass IIStatusOngoingWhereDistrict of Columbia
- Medical device recall Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery. Class IIFDA’s classSep 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedSep 28, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Texas, Washington and Wisconsin named
- Medical device recall Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike Firm noted an increase in customer reports of leaks. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2022ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Roadrunner PC Hydrophilic Wire Guide REFERENCE Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may… Class IIFDA’s classSep 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Roadrunner PC Hydrophilic Wire Guide REFERENCE Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may… Class IIFDA’s classSep 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Roadrunner PC Hydrophilic Wire Guide REFERENCE Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may… Class IIFDA’s classSep 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Roadrunner PC Hydrophilic Wire Guide REFERENCE Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may… Class IIFDA’s classSep 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may… Class IIFDA’s classSep 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may… Class IIFDA’s classSep 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may… Class IIFDA’s classSep 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may… Class IIFDA’s classSep 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may… Class IIFDA’s classSep 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may… Class IIFDA’s classSep 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may… Class IIFDA’s classSep 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may… Class IIFDA’s classSep 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may… Class IIFDA’s classSep 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MicroClave Clear Neutral Connector Due to a manufacturing defect which results in a visible gap between the connector’s top and bottom housing. Class IIFDA’s classSep 21, 2022in FDA’s Enforcement Report53 statesnamed in where it went PublishedSep 21, 2022ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall 8.5” (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple… Due to a manufacturing defect which results in a visible gap between the connector’s top and bottom housing. Class IIFDA’s classSep 21, 2022in FDA’s Enforcement Report53 statesnamed in where it went PublishedSep 21, 2022ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall 6.5” (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock Due to a manufacturing defect which results in a visible gap between the connector’s top and bottom housing. Class IIFDA’s classSep 21, 2022in FDA’s Enforcement Report53 statesnamed in where it went PublishedSep 21, 2022ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall MicroClave Clear Neutral Connector Due to a manufacturing defect which results in a visible gap between the connector’s top and bottom housing. Class IIFDA’s classSep 21, 2022in FDA’s Enforcement Report53 statesnamed in where it went PublishedSep 21, 2022ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall 6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP. Accessory for… Due to a manufacturing defect which results in a visible gap between the connector’s top and bottom housing. Class IIFDA’s classSep 21, 2022in FDA’s Enforcement Report53 statesnamed in where it went PublishedSep 21, 2022ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall 6” (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check Valve, 3 Clamps, Rotating… Due to a manufacturing defect which results in a visible gap between the connector’s top and bottom housing. Class IIFDA’s classSep 21, 2022in FDA’s Enforcement Report53 statesnamed in where it went PublishedSep 21, 2022ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall GXL acetabular liners, orthopedic hip implant component Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. Class IIFDA’s classSep 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GXL acetabular liners, orthopedic hip implant component Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. Class IIFDA’s classSep 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GXL acetabular liners, orthopedic hip implant component Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. Class IIFDA’s classSep 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GXL acetabular liners, orthopedic hip implant component Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. Class IIFDA’s classSep 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GXL acetabular liners, orthopedic hip implant component Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. Class IIFDA’s classSep 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GXL acetabular liners, orthopedic hip implant component Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. Class IIFDA’s classSep 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GXL acetabular liners, orthopedic hip implant component Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. Class IIFDA’s classSep 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GXL acetabular liners, orthopedic hip implant component Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. Class IIFDA’s classSep 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GXL acetabular liners, orthopedic hip implant component Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. Class IIFDA’s classSep 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GXL acetabular liners, orthopedic hip implant component Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. Class IIFDA’s classSep 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Stryker USB Converter, Polaris Spectra Camera Certain units have the potential to exhibit infant failures whereby units either arrive non-functional, have the potential to become non-functional, or flash… Class IIFDA’s classSep 21, 2022in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 21, 2022ClassClass IIStatusTerminatedWhereArizona and Illinois
- Medical device recall Verify SixCess Challenge Pack Product contains incorrect chemical indicators in packaging. Class IIIFDA’s classSep 21, 2022in FDA’s Enforcement Report31 statesnamed in where it went PublishedSep 21, 2022ClassClass IIIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, Mississippi, Nebraska, New Hampshire, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wyoming
- Medical device recall Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package,… Burns of varying degrees can occur to patients with electrodes left in while in the MRI scanner as a result of inadequate safety information in the IFU. Class IIFDA’s classSep 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedSep 21, 2022ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, New Hampshire, Ohio and Washington named
- Medical device recall Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and… Acidified Concentrate Distribution System potential electrical safety hazard may result in electric shock, arching Class IIFDA’s classSep 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Helix Elite Inactivated Standard, labeled as: a Product not registered for use in the UK Class IIIFDA’s classSep 21, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 21, 2022ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall PTS Panels CHOL+GLU Test Strips (REF 1765) Incorrect instructions for use were packaged into the final product. Class IIIFDA’s classSep 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 21, 2022ClassClass IIIStatusCompletedWhereNationwide, and Virginia named
- Medical device recall ZAP-X Radiosurgery System Software issue identified in cases of initial patient setup with large (greater-than-or-equal-to 1.5 degrees) rotational deviations, between digitally… Class IIFDA’s classSep 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedSep 21, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, Colorado, Florida and Maryland named
- Medical device recall BIOPHEN UFH Control Plasma Incorrect product labeling was included in the package. Class IIIFDA’s classSep 21, 2022in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 21, 2022ClassClass IIIStatusTerminatedWhereIllinois and Michigan
- Medical device recall Pinnacle3 Radiation Therapy Planning System When computing a radiation dose in the system, the exported dose information is incorrect when there is more than one beam attached to the prescription and… Class IIFDA’s classSep 21, 2022in FDA’s Enforcement Report21 statesnamed in where it went PublishedSep 21, 2022ClassClass IIStatusOngoingWhereCalifornia, Florida, Georgia, Iowa, Illinois, Massachusetts, Maryland, Maine, Michigan, Minnesota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Rhode Island, South Carolina, Tennessee, Texas and Washington
- Medical device recall INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory… The INOmax DSIR Delivery System, manufactured by Mallinckrodt Pharmaceuticals, is not compatible with the upgraded version of the Leoni Plus ventilator,… Class IIFDA’s classSep 21, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 21, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall QIAcube Connect MDx During the “Load tip racks and enzymes” step of the run set-up, the info screen indicates “minimal volume to be loaded”, but the indicated volume is instead… Class IIFDA’s classSep 21, 2022in FDA’s Enforcement Report26 statesnamed in where it went PublishedSep 21, 2022ClassClass IIStatusOngoingWhereArizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin
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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