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 DeRoyal NEURO PACK 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 NEURO PACK 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 CRANI PACK 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 CRANI PACK 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 LAMINECTOMY PACK 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 LUMBAR FUSION PACK 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 PACEMAKER ICD PACK 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 PACEMAKER ICD PACK 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 SHOULDER ARTHOSCOPY PACK 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 CRANI PACK 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 CRANI 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 HAND PACK 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 HAND PACK 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 PAIN TRAY 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 PAIN TRAY 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 CNRV PERIPHERAL VAS PACK 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 CNRV SPINAL PACK 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 CARDIAC LINEN PACK 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 CMC POSTERIOR SPINE PACK 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 LUMBAR DISC PACK 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 LUMBAR DISC PACK 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 ANTERIOR APPROACH TOTAL HIP A&B PGYBK 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 GU PACK 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 GU PACK 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 NEURO PACK 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 LAMI/CRANI PACK 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 LOCAL ANESTHESIA PACK 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 SHOULDER ARTHOSCOPY PACK 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 NEURO SPINE BACK PACK PGYBK 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 PACEMAKER ICD PACK 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 TOTAL KNEE PACK A & B PACK 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 BIOPSY PACKPACK 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 TRACECART SHOULDER ARTHROSCOPY TRACECART 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 TRACECART POSTEROR LUMBAR FUSION TRACECART 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 TRACECART POSTEROR LAMI MICRODISC TRACECART 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 CATARACT PACK 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 CATARACT PACK 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 CATARACT PACK 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 CATARACT PACK 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 CATARACT PACK 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 CATARACT PACK 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 CATARACT 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 IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, except Japan Siemens Material Number… Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SMN):… Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Oncentra Brachy radiation therapy planning system software. A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling 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 Cordis Angiographic Catheter Extensions There is a potential for separation at the male connector. Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, District of Columbia, Florida, Georgia, Kentucky, Louisiana, Maryland, Mississippi, New York, Ohio, Puerto Rico, Texas, West Virginia and Wyoming named
- Medical device recall Dewei DNA/RNA Preservation Kit Products were distributed in the United States without FDA authorization or clearance. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 14, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 14, 2022ClassClass IStatusOngoingWhereCalifornia, Florida, Kentucky and Michigan
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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