Medical devices, 2020
Shortlist up to four to read them side by side.
3,055 medical device recalls FDA’s Enforcement Report published in 2020, 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.
3,055of 3,055 medical device recallsshown with your filters
The list
- Medical device recall smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL A manufacturing error resulted in out of specification R3 Acetabular Shells Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 17, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Philips SureSigns VM1SpO2, C02, Rec Philips has identified a Philips SureSigns VM1 monitor in the possession of a clinical user that was not intended for commercial distribution and for which… Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and New Jersey named
- Medical device recall IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals,… Images may potentially become corrupt while using the system. Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJun 17, 2020ClassClass IIStatusCompletedWhereNationwide, and Arizona, California, Florida, Louisiana, Massachusetts, Michigan, Missouri, North Carolina, New Hampshire, New York, Oregon and Texas named
- Medical device recall RayStation 4.0 to RayStation 5 Service Pack 2 - Product Usage: For radiation therapy and medical oncology… Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation… Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, District of Columbia, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Missouri, New Jersey, Oklahoma, Tennessee, Texas, Utah and Virginia named
- Medical device recall RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiation therapy and medical oncology… Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation… Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, District of Columbia, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Missouri, New Jersey, Oklahoma, Tennessee, Texas, Utah and Virginia named
- Medical device recall RayStation 6, UDI # 07350002010013 - Product Usage: For radiation therapy and medical oncology which can also… Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation… Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, District of Columbia, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Missouri, New Jersey, Oklahoma, Tennessee, Texas, Utah and Virginia named
- Medical device recall RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage: For radiation therapy and medical oncology… Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation… Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, District of Columbia, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Missouri, New Jersey, Oklahoma, Tennessee, Texas, Utah and Virginia named
- Medical device recall RayStation 6 Service Pack 3, UDI # 07350002010242 - Product Usage: For radiation therapy and medical oncology… Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation… Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, District of Columbia, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Missouri, New Jersey, Oklahoma, Tennessee, Texas, Utah and Virginia named
- Medical device recall RayStation 8A, UDI # 07350002010112 - Product Usage: For radiation therapy and medical oncology which can… Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation… Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, District of Columbia, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Missouri, New Jersey, Oklahoma, Tennessee, Texas, Utah and Virginia named
- Medical device recall RayStation 8A Service Pack 1, UDI # 07350002010136 - Product Usage: For radiation therapy and medical… Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation… Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, District of Columbia, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Missouri, New Jersey, Oklahoma, Tennessee, Texas, Utah and Virginia named
- Medical device recall RayStation 8B, UDI # 07350002010129 - Product Usage: For radiation therapy and medical oncology which can… Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation… Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, District of Columbia, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Missouri, New Jersey, Oklahoma, Tennessee, Texas, Utah and Virginia named
- Medical device recall RayStation 8B Service Pack 1, UDI # 07350002010204 - Product Usage: For radiation therapy and medical… Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation… Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, District of Columbia, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Missouri, New Jersey, Oklahoma, Tennessee, Texas, Utah and Virginia named
- Medical device recall RayStation 8B Service Pack 2, UDI # 07350002010235 - Product Usage: For radiation therapy and medical… Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation… Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, District of Columbia, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Missouri, New Jersey, Oklahoma, Tennessee, Texas, Utah and Virginia named
- Medical device recall RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation therapy and medical oncology which can… Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation… Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, District of Columbia, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Missouri, New Jersey, Oklahoma, Tennessee, Texas, Utah and Virginia named
- Medical device recall RayStation 9B, UDI # 07350002010266 - Product Usage: For radiation therapy and medical oncology which can… Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation… Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, District of Columbia, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Missouri, New Jersey, Oklahoma, Tennessee, Texas, Utah and Virginia named
- Medical device recall RayStation 9B Service Pack 1, UDI # 07350002010297 - Product Usage: For radiation therapy and medical… Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation… Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, District of Columbia, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Missouri, New Jersey, Oklahoma, Tennessee, Texas, Utah and Virginia named
- Medical device recall RayStation 6 Service Pack 1, UDI #s 07350002010037, 07350002010082 - Product Usage: For radiation therapy and… Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation… Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, District of Columbia, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Missouri, New Jersey, Oklahoma, Tennessee, Texas, Utah and Virginia named
- Medical device recall RayStation 7, UDI # 07350002010068 - Product Usage: For radiation therapy and medical oncology which can also… Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation… Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, District of Columbia, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Missouri, New Jersey, Oklahoma, Tennessee, Texas, Utah and Virginia named
- Medical device recall A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Plate-Cage 32x21x15 7 A… Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage. Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJun 17, 2020ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Kansas, Kentucky, Louisiana, North Carolina, South Dakota, Texas and Wisconsin named
- Medical device recall A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Open Interbody 32x24x12 7… Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage. Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJun 17, 2020ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Kansas, Kentucky, Louisiana, North Carolina, South Dakota, Texas and Wisconsin named
- Medical device recall BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto… The recalling firm confirmed that BD FACS Sample Prep Assistant (SPA) II and III users may encounter probes with unacceptable wear prior to reaching the 2500… Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Colorado, Connecticut, Georgia, Illinois, Massachusetts, Maryland, Michigan, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Vermont named
- Medical device recall BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The BD FACSCanto system with BD… The recalling firm confirmed that SPA II and III users may encounter probes with unacceptable wear prior to reaching the 2500 piercings guideline indicated in… Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Colorado, Connecticut, Georgia, Illinois, Massachusetts, Maryland, Michigan, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Vermont named
- Medical device recall BD FACS Sample Prep Assistant (SPA) III - Product Usage: Prep Assistant III is intended to prepare human… The recalling firm confirmed that SPA II and III users may encounter probes with unacceptable wear prior to reaching the 2500 piercings guideline indicated in… Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Colorado, Connecticut, Georgia, Illinois, Massachusetts, Maryland, Michigan, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Vermont named
- Medical device recall Infant/Child Reduced Energy Defibrillation Electrodes Packaging of infant child reduced energy electrodes was not properly sealed. Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, 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 Infant Child Starter Kits Packaging of infant child reduced energy electrodes was not properly sealed. Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, 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 Omnipod DASH Insulin Management System (mg/dL configuration) After the device has been in use for about 2 months, data processing in the PDM can be slowed such that the Bolus Calculator fails to accurately subtract the… Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Omnipod DASH Insulin Management System (mmol/L configuration) After the device has been in use for about 2 months, data processing in the PDM can be slowed such that the Bolus Calculator fails to accurately subtract the… Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Sterile Custom Packs to be used in surgical procedures. The surgical gowns were manufactured in a facility that is not registered by the FDA. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and Pennsylvania named
- Medical device recall Sterile Custom Packs to be used in surgical procedures. The surgical gowns were manufactured in a facility that is not registered by the FDA. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and Pennsylvania named
- Medical device recall Custom Packs to be used in surgical procedures. The surgical gowns were manufactured in a facility that is not registered by the FDA. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and Pennsylvania named
- Medical device recall Sterile Custom Packs to be used in surgical procedures. The surgical gowns were manufactured in a facility that is not registered by the FDA. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and Pennsylvania named
- Medical device recall Sterile Custom Packs to be used in surgical procedures. The surgical gowns were manufactured in a facility that is not registered by the FDA. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and Pennsylvania named
- Medical device recall Sterile Custom Packs to be used in surgical procedures. The surgical gowns were manufactured in a facility that is not registered by the FDA. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and Pennsylvania named
- Medical device recall Sterile Custom Packs to be used in surgical procedures. The surgical gowns were manufactured in a facility that is not registered by the FDA. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and Pennsylvania named
- Medical device recall Sterile Custom Packs to be used in surgical procedures. The surgical gowns were manufactured in a facility that is not registered by the FDA. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and Pennsylvania named
- Medical device recall Sterile Custom Packs to be used in surgical procedures. The surgical gowns were manufactured in a facility that is not registered by the FDA. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and Pennsylvania named
- Medical device recall Sterile Custom Packs to be used in surgical procedures. The surgical gowns were manufactured in a facility that is not registered by the FDA. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and Pennsylvania named
- Medical device recall Sterile Custom Packs to be used in surgical procedures. The surgical gowns were manufactured in a facility that is not registered by the FDA. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and Pennsylvania named
- Medical device recall Sterile Custom Packs to be used in surgical procedures. The surgical gowns were manufactured in a facility that is not registered by the FDA. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and Pennsylvania named
- Medical device recall Sterile Custom Packs to be used in surgical procedures. The surgical gowns were manufactured in a facility that is not registered by the FDA. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and Pennsylvania named
- Medical device recall Sterile Custom Packs to be used in surgical procedures. The surgical gowns were manufactured in a facility that is not registered by the FDA. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and Pennsylvania named
- Medical device recall OSTEOVATIONEX 2CC INJECT FORMULA Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall OSTEOVATIONEX 3CC INJECT FORMULA Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall OSTEOVATIONEX 5CC INJECT FORMULA Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall OSTEOVATION 5CC INJECT FORMULA Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall OSTEOVATION 10CC INJECT FORMULA Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall OSTEOVATIONEX 5CC IMPACTFORMULA Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall OSTEOVATIONEX 3CC IMPACTFORMULA Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming 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.”
Your shortlist0 of 4
Add one more to compare.