Medical devices, 2021
Shortlist up to four to read them side by side.
2,303 medical device recalls FDA’s Enforcement Report published in 2021, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
2,303of 2,303 medical device recallsshown with your filters
The list
- Medical device recall Prime TC-transport chair intended for medical purposes to assist a person in performing an activity that the… Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall InTouch 2131-intended to support a human patient in an acute care setting Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Proform- support surface is used to assist in the prevention and treatment of all categories/stages of… Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ComfortGel - assists in the prevention and treatment of all pressure injury stages Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IsoGel Air - support surface assists in the prevention and treatment of all pressure ulcers stages Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital… Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Isolibrium Support Surface - support surface assists in the prevention and treatment of all pressure injury… Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital… Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TruRize Clinical Chair - support structure that places human occupants in upright, seated, recline, supine,… Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Symmetry Plus Treatment Recliner - general hospital use as a convenient seating surface for patients or… Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Michael Graves with Stryker Highback Chair-intended for pediatric and adult person guest and patient seating… Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Stretcher Chair-for use in all acute care hospitals and medical outpatient services Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CUB Pediatric Crib- intended to provide a pediatric patient support surface for medical purposes and to… Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Electric MedSurg Bed FL23 - AC-powered adjustable hospital bed with four built-in electric DC motors and… Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GoBed II MedSurg Bed Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge Packaging-pouches with wrinkles across the Tyvek side may compromise the integrity of the pouch’s sterile barrier Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MYLA software Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ETEST IMIPENEM RELEBACTAM Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Chassis Label - “CIRRUS HD-OCT Rx-Only” Product Label Exterior RX - “CIRRUS HD-OCT Due to failure to acquire pre-market clearance for its high resolution tomographic/biomicroscope imaging device (Model 6000) prior to commercializing the… Class IIFDA’s classAug 18, 2021in FDA’s Enforcement Report53 statesnamed in where it went PublishedAug 18, 2021ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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
- Medical device recall Medtronic StimLoc Burr Hole Cover Excess nylon flash on the clip. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement Report47 statesnamed in where it went PublishedAug 18, 2021ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Grasper/Retriever, Alligator Jaw 2.4 mm x 5 mm x 230 cm Mislabeled: Devices labeled as catalog #7208 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 230 cm) may actually be catalog #7226 (Grasper/Retriever,… Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 18, 2021ClassClass IIStatusCompletedWhereNationwide, and California, Colorado and Michigan named
- Medical device recall Grasper/Retriever, Alligator Jaw, Rat Tooth 2.4 mm x 8 mm x 230 cm Mislabeled: Devices labeled as catalog #7208 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 230 cm) may actually be catalog #7226 (Grasper/Retriever,… Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 18, 2021ClassClass IIStatusCompletedWhereNationwide, and California, Colorado and Michigan named
- Medical device recall Medline Shoulder CDS convenience kits The kits may contain an expired component. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide, and Minnesota, Nebraska and Pennsylvania named
- Medical device recall Medline Knee Arthroscopy Kit, convenience kit The kits may contain an expired component. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide, and Minnesota, Nebraska and Pennsylvania named
- Medical device recall Medline Total Knee, convenience kit The kits may contain an expired component. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide, and Minnesota, Nebraska and Pennsylvania named
- Medical device recall Medline Arthroscopy Kit, convenience kit The kits may contain an expired component. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide, and Minnesota, Nebraska and Pennsylvania named
- Medical device recall Cordis SABER PTA Balloon Dilation Catheter, 4F The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide, and California and Ohio named
- Medical device recall Cannulated graduated drill bit 1.9 mm diameter, with AO QC system Traces of corrosion on the laser marking was detected on cannulated graduated drill bit, which could lead to the emission of wear / corrosion particles in the… Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide, and New Jersey named
- Medical device recall Advance Dx 100 Blood Collection Card Quantity 25 Due to high glucose test results when using the blood collection cards. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide, and Maryland and North Carolina named
- Medical device recall Prelude SNAP Splittable Sheath Introducer There is a potential that 7F sheaths are packaged as 10F sheaths. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement Report29 statesnamed in where it went PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Texas, Virginia, Vermont and Wisconsin
- Medical device recall Prelude SNAP Splittable Sheath Introducer There is a potential that 7F sheaths are packaged as 10F sheaths. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement Report29 statesnamed in where it went PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Texas, Virginia, Vermont and Wisconsin
- Medical device recall Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy… Potential for a manufacturing assembly error-may result in a non-functional audio indicator of device activation or a non-functional device, may cause… Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, Connecticut, Georgia, Indiana, Massachusetts, Maryland, Minnesota, New York, Ohio, Texas, Virginia and Washington named
- Medical device recall Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 - Kaluza C Single Perpetual… Software anomalies that may lead to the generation of erroneous results. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall smith&nephew BHR SQUARE HEADED NAIL The nail head may become detached during surgery. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MERITMEDICAL Prelude Short Sheath Introducer There is a potential that a package sheath contains an incorrect dilator. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Hawaii, Idaho, Kansas, Minnesota, Missouri, Texas and Utah named
- Medical device recall FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Due to product complaints received for false negative results (dropouts) with blood culture identification panel potential caused by a pouch manufacturing… Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida, Michigan, New Jersey, Ohio, Virginia and Wisconsin named
- Medical device recall CUTTING ELECTRODE BIPO 24.5FR Product labeled as Cutting Electrode may contain BIVAP electrode. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Indiana, Massachusetts and New Hampshire named
- Medical device recall TJM6008 Jamshidi” Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 15 cm Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedAug 18, 2021ClassClass IIStatusOngoingWhereNationwide, and Arizona, Connecticut, District of Columbia, Florida, Illinois, Massachusetts, Michigan, Missouri, New York, Oklahoma, Texas and Virginia named
- Medical device recall EJM4011 Jamshidi Evolve” Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedAug 18, 2021ClassClass IIStatusOngoingWhereNationwide, and Arizona, Connecticut, District of Columbia, Florida, Illinois, Massachusetts, Michigan, Missouri, New York, Oklahoma, Texas and Virginia named
- Medical device recall TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79mm TIN3015 Illinois Bone Marrow… Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedAug 18, 2021ClassClass IIStatusOngoingWhereNationwide, and Arizona, Connecticut, District of Columbia, Florida, Illinois, Massachusetts, Michigan, Missouri, New York, Oklahoma, Texas and Virginia named
- Medical device recall Exactech BIOLOX delta Femoral Head, 36m O.D. Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36-03 (36mm +3.5). Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36-03 (36mm +3.5). Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusCompletedWhereNationwide
- Medical device recall The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack… Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedAug 18, 2021ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Florida and Michigan named
- Medical device recall Simpleware ScanIP software A issue (bug) has been identified with the interface and image software which could result in anatomical orientation tags/labels being displayed incorrectly. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide, and California and Florida named
- Medical device recall Simpleware ScanIP medical software A issue (bug) has been identified with the interface and image software which could result in anatomical orientation tags/labels being displayed incorrectly. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide, and California and Florida named
- Medical device recall ACCESS SARS-CoV-2 Antigen SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis . Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, Wisconsin and West Virginia named
- Medical device recall Access SARS-CoV-2 Antigen Calibrators SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis . Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, Wisconsin and West Virginia named
- Medical device recall ACCESS SARS-CoV-2 ANTIGEN QC SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis . Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, Wisconsin and West Virginia 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.”
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