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 5, 2026.
2,192of 2,192 medical device recallsshown with your filters
The list
- Medical device recall HENRY SCHEIN, SINGLE SHOT EPIDURAL Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HENRY SCHEIN, Blue Tail Custom Pack Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HENRY SCHEIN, BONE MARROW KIT Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HENRY SCHEIN, Labiaplasty PackItem No.570-3118 Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HENRY SCHEIN, ILR Insertion Tray Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRADIS HEALTHCARE, CURVED TIP SYRINGE Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRADIS HEALTHCARE, Lipo Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRADIS HEALTHCARE, Phlebectomy Pack Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRADIS HEALTHCARE, Thoracic Phleb Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRADIS HEALTHCARE, Ablation Pack Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRADIS HEALTHCARE, Phleb Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRADIS HEALTHCARE, Vasc Vein Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRADIS HEALTHCARE, Surgery PK Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRADIS HEALTHCARE, Vein Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRADIS HEALTHCARE, Angioplasty Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRADIS HEALTHCARE, Vein RF Pack Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRADIS HEALTHCARE, VENOUS ACCESS PACK Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRADIS HEALTHCARE, Medical Vein Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRADIS HEALTHCARE, Vein & Laser Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall www.StradisHealthcare.com, Endovenous Pack Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRADIS HEALTHCARE, Endo Pack Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRADIS HEALTHCARE, Vein Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRADIS HEALTHCARE, Varicosity Basic Pack Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRADIS HEALTHCARE, Femoral, Vasc Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRADIS HEALTHCARE, Angio Pack Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRADIS HEALTHCARE, Breast Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HENRY SCHEIN, Vas Pack Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HENRY SCHEIN, Vas Reversal Pack Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRADIS HEALTHCARE, TIP, SURGE-O-VAC .125” GREEN Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall NUVASIVE MAGEC MAGEC 2 Rod During accelerated shelf-life extension studies it was noted that the final packaging was experiencing a potential of failure of the sterile packaging barrier… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall DeRoyal MINOR ORAL / ENT PACK DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. Class IIFDA’s classDec 21, 2022in FDA’s Enforcement Report23 statesnamed in where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereAlabama, Arizona, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall DeRoyal MAJOR ORAL PACK RF DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. Class IIFDA’s classDec 21, 2022in FDA’s Enforcement Report23 statesnamed in where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereAlabama, Arizona, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall DeRoyal EYE PACK DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. Class IIFDA’s classDec 21, 2022in FDA’s Enforcement Report23 statesnamed in where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereAlabama, Arizona, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall DeRoyal EXTREMITY TRAY PGYBK DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. Class IIFDA’s classDec 21, 2022in FDA’s Enforcement Report23 statesnamed in where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereAlabama, Arizona, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall DeRoyal EYE TRAY DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. Class IIFDA’s classDec 21, 2022in FDA’s Enforcement Report23 statesnamed in where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereAlabama, Arizona, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall DeRoyal PEDI ORTHO PACK DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. Class IIFDA’s classDec 21, 2022in FDA’s Enforcement Report23 statesnamed in where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereAlabama, Arizona, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall GEO-MED KNEE ARTHROSCOPY PACK DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. Class IIFDA’s classDec 21, 2022in FDA’s Enforcement Report23 statesnamed in where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereAlabama, Arizona, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall GEO-MED TOTAL KNEE PACK A & B PGYK DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. Class IIFDA’s classDec 21, 2022in FDA’s Enforcement Report23 statesnamed in where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereAlabama, Arizona, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall GEO-MED SHOULDER ARTHROSCOPY KNEE PACK DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. Class IIFDA’s classDec 21, 2022in FDA’s Enforcement Report23 statesnamed in where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereAlabama, Arizona, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall DeRoyal PICC LINE TRAY PGYBK DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. Class IIFDA’s classDec 21, 2022in FDA’s Enforcement Report23 statesnamed in where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereAlabama, Arizona, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall GEO-MED PODIATRY PACK PGYBK DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. Class IIFDA’s classDec 21, 2022in FDA’s Enforcement Report23 statesnamed in where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereAlabama, Arizona, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall GEO-MED OPTHALMOLOGY CSTM PCK DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. Class IIFDA’s classDec 21, 2022in FDA’s Enforcement Report23 statesnamed in where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereAlabama, Arizona, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall GEO-MED OPTHALMOLOGY CSTM PCK DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. Class IIFDA’s classDec 21, 2022in FDA’s Enforcement Report23 statesnamed in where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereAlabama, Arizona, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall DeRoyal SHOULDER ARTHORSCOPY PACK RF DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. Class IIFDA’s classDec 21, 2022in FDA’s Enforcement Report23 statesnamed in where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereAlabama, Arizona, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall DeRoyal OPEN SHOULDER PROCEDURE PACK RF XXX Class IIFDA’s classDec 21, 2022in FDA’s Enforcement Report23 statesnamed in where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereAlabama, Arizona, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall DeRoyal OPEN SHOULDER PROCEDURE PACK RF DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. Class IIFDA’s classDec 21, 2022in FDA’s Enforcement Report23 statesnamed in where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereAlabama, Arizona, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall GEO-MED PLASTIC HAND PACK RF XXX Class IIFDA’s classDec 21, 2022in FDA’s Enforcement Report23 statesnamed in where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereAlabama, Arizona, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall GEO-MED PLASTIC HAND PACK RF XXX Class IIFDA’s classDec 21, 2022in FDA’s Enforcement Report23 statesnamed in where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereAlabama, Arizona, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Wisconsin
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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