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 Helix Elite” Molecular Standards: Inactivated Standard Real-time shelf life testing failed at 24 months Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedMar 9, 2022ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, District of Columbia, Florida, Iowa, Idaho, Kansas, Louisiana, Maryland, Minnesota, Missouri, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Virginia, Washington and West Virginia named
- Medical device recall Helix Elite” Molecular Standards: Inactivated Standard Real-time shelf life testing failed at 24 months Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedMar 9, 2022ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, District of Columbia, Florida, Iowa, Idaho, Kansas, Louisiana, Maryland, Minnesota, Missouri, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Virginia, Washington and West Virginia named
- Medical device recall da Vinci Xi and X 12-8 mm Conductive Cannula Reducer Conductive Cannula Reducer metal tip may get dislodged from the plastic shaft. Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedMar 9, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, 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 QC Sets and Panels: KWIK-STIK The Lactobacillus acidophilus negative control (item 0243 single KWIK-STIK) contained in the 8164 Cepheid Xpert GBS QC Set and 8165 Cepheid Smart GBS QC Set… Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedMar 9, 2022ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New Mexico, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture) The Lactobacillus acidophilus negative control (item 0243 single KWIK-STIK) contained in the 8164 Cepheid Xpert GBS QC Set and 8165 Cepheid Smart GBS QC Set… Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedMar 9, 2022ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New Mexico, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Everest MI XT Inner Dilator Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 9, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Everest MI XT Outer Dilator Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 9, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brasseler USA, K-WIRE, Double Trocar Smooth One lot of product was distributed in unsealed packaging Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedMar 9, 2022ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Idaho, Illinois, Michigan, Ohio, Pennsylvania, South Carolina, Tennessee and Texas named
- Medical device recall OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility. Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 9, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility. Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 9, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Alinity m Integrated Reaction Units (IRU) There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot. Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedMar 9, 2022ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, North Carolina, New Jersey, New York, Oklahoma, Rhode Island, South Dakota, Texas, Washington and Wisconsin named
- Medical device recall Bronchial Microbiology Brush The labeling for the Microbiology Brush identifies the device as a Bronchial Microbiology Brush. Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 9, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall KWIK-STIK, Quality control kit for culture media This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LYFO-DISK, Quality control kit for culture media This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall KWIK-STIK, Quality control kit for culture media This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MEDPOR Titan OFW - MTB - Right - 1.0mm Inside the packaging of one reported item a non-conforming product was found. Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BUTLER Clear Dip, 12 bottles/case Product lacks premarket clearance. Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NavitrackER Kit A: Knee The product was released for distribution without passing sterilization results, which could potentially lead to insufficient sterility of the product. Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedMar 9, 2022ClassClass IIStatusOngoingWhereNationwide, and Arkansas, New York, Ohio, Tennessee and Texas named
- Medical device recall Michels Transport Medium, 20ML Prefilled Cont Product stored incorrectly in temperature controlled setting instead of refrigeration. Class IIFDA’s classMar 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedMar 2, 2022ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Florida, North Carolina, New York and Texas named
- Medical device recall Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endurant Stent Graft System Stent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Class IIFDA’s classMar 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedMar 2, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall NobelReplace Conical Connection RP 4.3x11.5 mm Due to 16 complaints related to drivers not engaging in implants. Class IIFDA’s classMar 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedMar 2, 2022ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maine, Michigan, Minnesota, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy… Due to Label/Pouch mix-up. Class IIFDA’s classMar 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 2, 2022ClassClass IIStatusOngoingWhereNationwide, and Florida and Maryland named
- Medical device recall IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software Tile kits that allow one to install and situate a video camera within a patient environment are not fitting properly in some domestic institution ceiling tile… Class IIFDA’s classMar 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedMar 2, 2022ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Connecticut, District of Columbia, Florida, Hawaii, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, Nebraska, New Jersey, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Texas, Virginia and West Virginia named
- Medical device recall REF: 5921-018-135, Stryker Color Cuff, 18” (Red), Quick Connect Single Port, Single Bladder Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs. Class IIFDA’s classMar 2, 2022in FDA’s Enforcement Report3 statesnamed in where it went PublishedMar 2, 2022ClassClass IIStatusTerminatedWhereKansas, Oklahoma and Texas
- Medical device recall BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a… May shed contaminant particles into the urine specimen that may be misidentified as Red Blood Cells when used in conjunction with the Sysmex UF-1000i or… Class IIIFDA’s classMar 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2022ClassClass IIIStatusOngoingWhereNationwide, and Illinois named
- Medical device recall BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr There is a potential to leak from the catheter where it connects to the drain bag Class IIFDA’s classMar 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedMar 2, 2022ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Florida, Georgia, Idaho, Illinois, Louisiana, Maryland, Maine, Minnesota, North Dakota, Nebraska, New Jersey, Ohio, Pennsylvania, South Dakota and Wisconsin named
- Medical device recall BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr There is a potential to leak from the catheter where it connects to the drain bag Class IIFDA’s classMar 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedMar 2, 2022ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Florida, Georgia, Idaho, Illinois, Louisiana, Maryland, Maine, Minnesota, North Dakota, Nebraska, New Jersey, Ohio, Pennsylvania, South Dakota and Wisconsin named
- Medical device recall DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery Class IIFDA’s classMar 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 2, 2022ClassClass IIStatusTerminatedWhereNationwide, and Florida, Indiana and Puerto Rico named
- Medical device recall RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery Class IIFDA’s classMar 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 2, 2022ClassClass IIStatusTerminatedWhereNationwide, and Florida, Indiana and Puerto Rico named
- Medical device recall Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Size A, 60 MM The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Class IIFDA’s classMar 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 11 MM, 55 MM Long The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Class IIFDA’s classMar 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 14 MM, 55 MM Long The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Class IIFDA’s classMar 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 18 MM, 55 MM Long The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Class IIFDA’s classMar 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 11 MM, 83 MM Long The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Class IIFDA’s classMar 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 12 MM, 83 MM Long The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Class IIFDA’s classMar 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 13 MM, 83 MM Long The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Class IIFDA’s classMar 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 MM, 83 MM Long The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Class IIFDA’s classMar 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall meridian bioscience immunocard STAT! Rotavirus test The product was incorrectly shipped at room temperature rather than refrigerated. Class IIFDA’s classMar 2, 2022in FDA’s Enforcement Report7 statesnamed in where it went PublishedMar 2, 2022ClassClass IIStatusTerminatedWhereFlorida, Illinois, Louisiana, Mississippi, North Carolina, Ohio and Texas
- Medical device recall RNAstill Molecular Transport Medium Vial The product does not have 510(k) clearance. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedFeb 23, 2022ClassClass IStatusTerminatedWhereNationwide, and Alabama, Colorado, Florida, Georgia, Idaho, Indiana, Kentucky, Maryland, North Carolina, Nevada, New York, Ohio, Oregon, Tennessee, Utah, Virginia, Washington and West Virginia named
- Medical device recall bellavista 1000 ventilator Potential cessation in ventilation can occur under specific conditions. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedFeb 23, 2022ClassClass IStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Dakota, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device The firm received reports indicating PTD tip separation during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 23, 2022ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device The firm received reports indicating PTD tip separation during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 23, 2022ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device The firm received reports indicating PTD tip separation during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 23, 2022ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device The firm received reports indicating PTD tip separation during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 23, 2022ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6,… The firm received reports indicating PTD tip separation during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 23, 2022ClassClass IStatusTerminatedWhereNationwide
- Medical device recall 5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing… The firm received reports indicating PTD tip separation during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 23, 2022ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device) The firm received reports indicating PTD tip separation during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 23, 2022ClassClass IStatusTerminatedWhereNationwide
- Medical device recall OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus… The detergent and alcohol tank tubing may have been incorrectly assembled in the OER-Elite. Class IIFDA’s classFeb 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 23, 2022ClassClass 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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