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 Ysiosystem with VC10 software version Siemens Healthineers has identified a software error in previous software version VB10 for the Ysio fully automated system. Class IIFDA’s classApr 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 6, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling Class IIFDA’s classApr 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedApr 6, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Maryland, Minnesota, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee and Texas named
- Medical device recall Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling Class IIFDA’s classApr 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedApr 6, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Maryland, Minnesota, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee and Texas named
- Medical device recall Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 -… Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months. Class IIFDA’s classApr 6, 2022in FDA’s Enforcement Report8 statesnamed in where it went PublishedApr 6, 2022ClassClass IIStatusTerminatedWhereAlabama, Georgia, Illinois, Montana, Pennsylvania, Tennessee, Texas and Wisconsin
- Medical device recall BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for Multi-Access Port (MAP)… Product was distributed with incorrect expiration date. Class IIFDA’s classApr 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 6, 2022ClassClass IIStatusTerminatedWhereNationwide, and Ohio and Oklahoma named
- Medical device recall BALLARD* Multi-Access Port Catheter, Double Swivel Y Elbow, Adult, 14 French Product was distributed with incorrect expiration date. Class IIFDA’s classApr 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 6, 2022ClassClass IIStatusTerminatedWhereNationwide, and Ohio and Oklahoma named
- Medical device recall BALLARD* Multi-Access Port (MAP) Catheter, Double Swivel Y- Adult, 16 French Product was distributed with incorrect expiration date. Class IIFDA’s classApr 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 6, 2022ClassClass IIStatusTerminatedWhereNationwide, and Ohio and Oklahoma named
- Medical device recall TomoHelical and TomoDirect plans in RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B and 11A If the dynamic jaw mode is used and an optimization is continued after changing the dose grid or modifying the target ROI, the positions of the jaws may change… Class IIFDA’s classApr 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedApr 6, 2022ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Georgia, Iowa, Illinois, Missouri, Mississippi, North Carolina, Oklahoma, Oregon, South Carolina, Tennessee, Washington and Wisconsin named
- Medical device recall RayStation/RayPlan versions 4 - 11A, including service packs An issue where the combined density in a dose grid voxel partially covered by the External ROI and also partially covered by an ROI of type Bolus, Support or… Class IIFDA’s classApr 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 6, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs: RayStation 4.0 Incorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation system. Class IIFDA’s classApr 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedApr 6, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Hanger-Bar 2P 45cm The Hanger-Bar is being recalled due to the potential for the set screw loosening as a result of a manufacturing issue (failure to apply Loctite adhesive). Class IIFDA’s classApr 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedApr 6, 2022ClassClass IIStatusOngoingWhereNationwide, and California, Illinois, Louisiana, Massachusetts, Nevada, Ohio, Oklahoma, Pennsylvania, Texas, Utah, Virginia and West Virginia named
- Medical device recall Hanger-Bar 2P 45cm The Hanger-Bar is being recalled due to the potential for the set screw loosening as a result of a manufacturing issue (failure to apply Loctite adhesive). Class IIFDA’s classApr 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedApr 6, 2022ClassClass IIStatusOngoingWhereNationwide, and California, Illinois, Louisiana, Massachusetts, Nevada, Ohio, Oklahoma, Pennsylvania, Texas, Utah, Virginia and West Virginia named
- Medical device recall EasyFuse Dynamic Compression System Instrument Pack The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking. Class IIFDA’s classApr 6, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedApr 6, 2022ClassClass IIStatusTerminatedWhereFlorida, North Carolina, Ohio and Texas
- Medical device recall Illumina NextSeq 550Dx There is a potential that the DNA sequence analyzer may short circuit shortly after disconnection and reconnection of circuit board or imaging module due to an… Class IIFDA’s classApr 6, 2022in FDA’s Enforcement Report31 statesnamed in where it went PublishedApr 6, 2022ClassClass IIStatusCompletedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, North Carolina, Nebraska, New Jersey, New Mexico, New York, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and West Virginia
- Medical device recall MiniMed 630G: MMT-1715, MMT-1754, MMT-1755 New or replacement insulin pumps are not pre-programmed with basal rates or other verified settings (bolus wizard settings, sensor settings, etc.), which must… Class IIFDA’s classApr 6, 2022in FDA’s Enforcement Report53 statesnamed in where it went PublishedApr 6, 2022ClassClass IIStatusOngoingWhereAlaska, 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, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Azurion systems with software release R2.0.x In the Azurion system, the user can add a new study to a patient by selecting the option “Add Study”. Class IIFDA’s classMar 30, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2022ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be… In 2018, Philips Respironics added foam replacement to the preventive maintenance schedule for these devices after discovering the polyester-based polyurethane… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 30, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2022ClassClass IStatusOngoingWhereNationwide
- Medical device recall BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [Item #110010372, 7MM], [Item #… Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Class IIFDA’s classMar 30, 2022in FDA’s Enforcement Report28 statesnamed in where it went PublishedMar 30, 2022ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Mississippi, North Carolina, Nebraska, New Mexico, New York, Ohio, Oklahoma, Oregon, South Carolina, Texas, Utah, Washington and Wyoming
- Medical device recall BIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [Item # 1318-12-126, DVR CROSSLOCK… Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Class IIFDA’s classMar 30, 2022in FDA’s Enforcement Report28 statesnamed in where it went PublishedMar 30, 2022ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Mississippi, North Carolina, Nebraska, New Mexico, New York, Ohio, Oklahoma, Oregon, South Carolina, Texas, Utah, Washington and Wyoming
- Medical device recall BIOMET TRAUMA A.L.P.S Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Class IIFDA’s classMar 30, 2022in FDA’s Enforcement Report28 statesnamed in where it went PublishedMar 30, 2022ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Mississippi, North Carolina, Nebraska, New Mexico, New York, Ohio, Oklahoma, Oregon, South Carolina, Texas, Utah, Washington and Wyoming
- Medical device recall BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Class IIFDA’s classMar 30, 2022in FDA’s Enforcement Report28 statesnamed in where it went PublishedMar 30, 2022ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Mississippi, North Carolina, Nebraska, New Mexico, New York, Ohio, Oklahoma, Oregon, South Carolina, Texas, Utah, Washington and Wyoming
- Medical device recall Outset Tablo Console Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device. Class IIFDA’s classMar 30, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedMar 30, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of… May show unexpected locus specific signals in addition to those at 14q32. Class IIIFDA’s classMar 30, 2022in FDA’s Enforcement ReportMinnesotathe one state its words name PublishedMar 30, 2022ClassClass IIIStatusTerminatedWhereMinnesota
- Medical device recall Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure… Incorrect extended expiration dates identified on the outer box label only, if product is used past the correct expiration date there is a potential for pain,… Class IIFDA’s classMar 30, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure… Incorrect extended expiration dates identified on the outer box label only, if product is used past the correct expiration date there is a potential for pain,… Class IIFDA’s classMar 30, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PERFUSOR SPACE - US VERSION Units not properly inspected prior to release to the market, may not function as indicated in the product labeling, resulting in syringe detection and infusion… Class IIFDA’s classMar 30, 2022in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 30, 2022ClassClass IIStatusTerminatedWhereMassachusetts and Vermont
- Medical device recall Compella Bariatric Bed System Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains. Class IIFDA’s classMar 30, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Compella Therapy Air Supply Unit Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains. Class IIFDA’s classMar 30, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medical Device products purchased from Family Dollar retail stores located in Alabama, Arkansas, Louisiana,… Potential exposure to rodents and rodent activity in the distribution center. Class IIFDA’s classMar 30, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMar 30, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Louisiana, Missouri, Mississippi and Tennessee named
- Medical device recall NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects NuOss Collagen (dental) was packaged with a Collatene Fibrillar Collagen(for oral wounds) rather than NuOss Collagen Block, may result in suboptimal bone repair Class IIFDA’s classMar 30, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMar 30, 2022ClassClass IIStatusOngoingWhereNationwide, and Georgia, New York, Virginia and Wisconsin named
- Medical device recall Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008 Labelled with an incorrect expiry date on the outer label with an extended expiry date than the validated shelf life. Class IIIFDA’s classMar 30, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 30, 2022ClassClass IIIStatusTerminatedWhereNationwide, and Connecticut and Texas named
- Medical device recall DigniCap Delta Scalp Cooling System, Product Number: 900-1001, Labeling: The DigniCap Scalp Cooling System… Instructions for Use (IFUs) updated to include use of a headband is now recommended for all patients and instructions for the application of the headband. Class IIFDA’s classMar 30, 2022in FDA’s Enforcement Report12 statesnamed in where it went PublishedMar 30, 2022ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, Kansas, Kentucky, Louisiana, North Carolina, New Jersey, New York, South Carolina and Wisconsin
- Medical device recall STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for… Illegal importation of COVID-19 AG Test kits into the U.S. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IStatusOngoingWhereNationwide
- Medical device recall Diagnostic Ultrasound System, ACUSON Juniper, UDI The clip store function in the ultrasound imaging system does not work when the system has a disk full error. Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Alinity s System software version2.8.0 Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash buffer instead of the intended 3 mL of wash buffer to wash the… Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Georgia, Illinois, Indiana, Maryland, Minnesota, Missouri, North Carolina, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Panther Fusion Extraction Reagent-X Failed stability specifications for reagent kits that may result in false negative test results. Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Massachusetts, Maryland, Maine, Michigan, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material Number: M00584040 Sterility of device is compromised due to a sterile barrier breach Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Number: M00584060 Sterility of device is compromised due to a sterile barrier breach Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DREAMTOME 44-30MM/260CM Material Number: M00584050 Sterility of device is compromised due to a sterile barrier breach Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DREAMTOME 44-30MM/450CM Material Number: M00584070 Sterility of device is compromised due to a sterile barrier breach Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DREAMTOME 49-20MM/260CM Material Number: M00584000 Sterility of device is compromised due to a sterile barrier breach Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DREAMTOME 49-20MM/450CM Material Number: M00584020 Sterility of device is compromised due to a sterile barrier breach Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DREAMTOME 49-30MM/260CM Material Number: M00584010 Sterility of device is compromised due to a sterile barrier breach Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DREAMTOME 49-30MM/450CM Material Number: M00584030 Sterility of device is compromised due to a sterile barrier breach Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HYDRATOME RX 44-20MM/260CM Material Number: M00583040 Sterility of device is compromised due to a sterile barrier breach Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HYDRATOME RX 44-20MM/450CM Material Number: M00583060 Sterility of device is compromised due to a sterile barrier breach Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HYDRATOME RX 44-30MM/260CM Material Number: M00583050 Sterility of device is compromised due to a sterile barrier breach Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HYDRATOME RX 44-30MM/450CM Material Number: M00583070 Sterility of device is compromised due to a sterile barrier breach Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide
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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