Medical devices, 2017
Shortlist up to four to read them side by side.
2,615 medical device recalls FDA’s Enforcement Report published in 2017, 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.
2,615of 2,615 medical device recallsshown with your filters
The list
- Medical device recall Covidien Nellcor SpO2 Forehead Sensor Labeling error: The label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex. Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Intact Disposable Wands (part of the Intact System) 777-110: 5 Pack 10mm Disposable Product Usage: The Intact… Product sterility compromised due to breach of sterile barrier Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Intact Disposable Wands (part of the Intact System) 900-112: 5 Pack 12mm Disposable Product Usage: The Intact… Product sterility compromised due to breach of sterile barrier Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Intact Disposable Wands (part of the Intact System) 777-112: 5 Pack 12mm Disposable Product Usage: The Intact… Product sterility compromised due to breach of sterile barrier Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Intact Disposable Wands (part of the Intact System) 777-112BT: 5 Pack 12mm Disposable Product Usage: The… Product sterility compromised due to breach of sterile barrier Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Intact Disposable Wands (part of the Intact System) 900-115: 5 Pack 15mm Disposable Product Usage: The Intact… Product sterility compromised due to breach of sterile barrier Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Intact Disposable Wands (part of the Intact System) 777-115: 5 Pack 15mm Disposable Product Usage: The Intact… Product sterility compromised due to breach of sterile barrier Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Intact Disposable Wands (part of the Intact System) 777-115BT: 5 Pack 15mm Disposable Product Usage: The… Product sterility compromised due to breach of sterile barrier Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Intact Disposable Wands (part of the Intact System) 900-120: 5 Pack 20mm Disposable Product Usage: The Intact… Product sterility compromised due to breach of sterile barrier Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Intact Disposable Wands (part of the Intact System) 777-120: 5 Pack 20mm Disposable Product Usage: The Intact… Product sterility compromised due to breach of sterile barrier Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Intact Disposable Wands (part of the Intact System) 777-120BT: 5 Pack 20mm Disposable Product Usage: The… Product sterility compromised due to breach of sterile barrier Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Intact Disposable Wands (part of the Intact System) 900-130: 5 Pack 30mm Disposable Product Usage: The Intact… Product sterility compromised due to breach of sterile barrier Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Allura Xper FD20 722012 is intended for: Cardiovascular and vascular X-ray imaging applications, including… Due to a production error, screws were not tightened to specified torque. Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportWashingtonthe one state its words name PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereWashington
- Medical device recall Allura Xper FD10 722026 is intended for: Cardiovascular and vascular X-ray imaging applications, including… Due to a production error, screws were not tightened to specified torque. Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportWashingtonthe one state its words name PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereWashington
- Medical device recall Allura Xper FD20 R8.2 722028 is intended for: Cardiovascular and vascular X-ray imaging applications,… Due to a production error, screws were not tightened to specified torque. Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportWashingtonthe one state its words name PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereWashington
- Medical device recall Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and vascular X-ray imaging applications,… Due to a production error, screws were not tightened to specified torque. Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportWashingtonthe one state its words name PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereWashington
- Medical device recall Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement… Four issues were uncovered by the recalling firm’s CAPA: 1) Burrs were found to be present on Left Housing, Right Housing and Barrel components, 2) Loose… Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement Report7 statesnamed in where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereCalifornia, Delaware, Maine, Nebraska, Ohio, Texas and Washington
- Medical device recall Brilliance iCT During a retrospective review of production documentation it was observed that the M6 Rotor Counterweight Bolt may have been improperly torqued. Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall OEC 9800. MDL Numbers: D222250, D141598 GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due to additional supplementation to the user documentation to… Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall OEC 9900 Elite GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due to additional supplementation to the user documentation to… Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Velara Generator with an old Firmware version used with Philips Allura Xper Systems (Allura 15 & 12… System may lock up. Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement Report16 statesnamed in where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereAlabama, California, District of Columbia, Georgia, Illinois, Kansas, Maryland, Missouri, North Carolina, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas and Washington
- Medical device recall Velara Generator with an old Firmware version used with the Philips Integris BH5000 System may lock up. Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement Report16 statesnamed in where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereAlabama, California, District of Columbia, Georgia, Illinois, Kansas, Maryland, Missouri, North Carolina, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas and Washington
- Medical device recall Juno DRF; Model: 709020 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy… The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement Report25 statesnamed in where it went PublishedFeb 1, 2017ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah and Wisconsin
- Medical device recall Apollo: Models: 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9784120131, 9784120231,… The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement Report25 statesnamed in where it went PublishedFeb 1, 2017ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah and Wisconsin
- Medical device recall Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of routine radiograph and general… The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement Report25 statesnamed in where it went PublishedFeb 1, 2017ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah and Wisconsin
- Medical device recall Apollo EZ: Model: 9784152036 Multi-function x-ray systems capable of routine radiograph and general… The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement Report25 statesnamed in where it went PublishedFeb 1, 2017ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah and Wisconsin
- Medical device recall Human Subclass Kit for use on the Beckman IMMAGE”/IMMAGE”800 Analyser Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results. Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement Report6 statesnamed in where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereCalifornia, Florida, Michigan, Minnesota, Ohio and Tennessee
- Medical device recall Human lgG4 Subclass kit for use on the Beckman Coulter AU” series This kit is intended for qualifying human… Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results. Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement Report6 statesnamed in where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereCalifornia, Florida, Michigan, Minnesota, Ohio and Tennessee
- Medical device recall Human lgG4 Subclass Liquid Reagent Kits For use on the Roche Cobas”6000 This kit is intended for qualifying… Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results. Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement Report6 statesnamed in where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereCalifornia, Florida, Michigan, Minnesota, Ohio and Tennessee
- Medical device recall Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera, lgG3 & 4 Latex reagent and lgG Antisera… Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results. Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement Report6 statesnamed in where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereCalifornia, Florida, Michigan, Minnesota, Ohio and Tennessee
- Medical device recall Human lgG4 Subclass Liquid Reagent Kits for use on the Siemens BN”II Analyser Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results. Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement Report6 statesnamed in where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereCalifornia, Florida, Michigan, Minnesota, Ohio and Tennessee
- Medical device recall Human lgG Subclass Liquid Reagent Kits for use on the Siemens BN”IJ Analyser Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results. Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement Report6 statesnamed in where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereCalifornia, Florida, Michigan, Minnesota, Ohio and Tennessee
- Medical device recall MininephThl Human lgG4 Kit Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results. Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement Report6 statesnamed in where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereCalifornia, Florida, Michigan, Minnesota, Ohio and Tennessee
- Medical device recall Unna-Z, Unna Boot with Zinc and Calamine, Compression Wrap, 1 Per Box, 3-4in x 10yds Medline Industries, Inc is recalling Unna Z Unna Boot Bandage 3 X10 and Unna Z Unna Boot Bandage 4 X10 due to contamination of the products with common mold… Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic… Pentax is initiating a Field Correction to revise the Instructions for Use of the Rigid Laryngostroboscopes Model 9106 and 9108. Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system Mallinckrodt discovered that some devices may have been manufactured with an out-of-tolerance manometer which can result in in an inaccurate proportional valve… Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement Report18 statesnamed in where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereCalifornia, Colorado, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Michigan, Minnesota, North Carolina, New Jersey, New Mexico, New York, Ohio, Pennsylvania and Texas
- Medical device recall Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC system for whole blood in vitro… under specific settings, an issue may occur during simultaneous Sensor Cartridge and Fluid Pack change on the cobas b 123 <2> POC system and cobas b 123 <4>… Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, Louisiana, Nebraska, Puerto Rico, South Carolina, Texas, Virginia and West Virginia named
- Medical device recall Sekisui Diagnostics Ammonia L3K¿ Assay Certain lots are showing an atypical decrease in optical density (OD) over time, which may result in an impact to performance at the high end of the linear… Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement Report12 statesnamed in where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereCalifornia, Delaware, Florida, Idaho, Illinois, Kansas, Massachusetts, Michigan, New Jersey, Rhode Island, Tennessee and Texas
- Medical device recall Atrium Medical Ocean Drains as follows: 2002-000 Ocean single drain, with in-line connectors and suction… Outer Packaging is not sterile Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atrium Medical Dual Chamber Ocean Drains as follows: 2020-000 Ocean dual chamber, in-line connectors and… Outer Packaging is not sterile Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atrium Medical Pediatric Chamber Ocean Drains as follows: 2012-320 Ocean Infant/Pediatric drain, with in-line… Outer Packaging is not sterile Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atrium Medical Ocean Blood Recovery Drains as follows: 2050-000 Ocean Blood Recovery drain with in-line… Outer Packaging is not sterile Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atrium Medical Oasis Single Drain as follows: 3600-100 Oasis single drain with in-line connector 3600-150… Outer Packaging is not sterile Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atrium Medical Oasis Pediatric Drain as follows: 3612-100 Oasis Infant/Pediatric drain with in-line… Outer Packaging is not sterile Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atrium Medical 3620-100: Oasis dual chamber drain with in-line connectors Outer Packaging is not sterile Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atrium Medical Oasis Blood Recovery Drains as follows: 3650-100 Oasis Blood Recovery drain with in-line… Outer Packaging is not sterile Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atrium Medical 400 Series Express Drains as follows: 4000-100N Express single collection drain with in-line… Outer Packaging is not sterile Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atrium Medical 16400 Express Mini 500 dry seal drain Product Usage: To evacuate air and/or fluid from the… Outer Packaging is not sterile Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2017ClassClass 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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