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 ARTIS pheno, Interventional fluoroscopic x-ray system Siemens has become aware of three potential software issues with ARTIS pheno systems with software version VE10B. Class IIFDA’s classNov 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE ADLT BLOOD CLUTURE COLLECT KIT, Reorder #: DYNDH1245 Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. Class IIFDA’s classNov 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 2, 2022ClassClass IIStatusOngoingWhereNationwide, and California named
- Medical device recall MEDLINE PHERIPHERAL BLOOD CULTURE DRAW, Reorder #: DYNDH1561 Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. Class IIFDA’s classNov 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 2, 2022ClassClass IIStatusOngoingWhereNationwide, and California named
- Medical device recall MEDLINE BLOOD CLUTURE KIT, Reorder #: DYNDH1592 Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. Class IIFDA’s classNov 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 2, 2022ClassClass IIStatusOngoingWhereNationwide, and California named
- Medical device recall MEDLINE 24 BLOOD CLUTURE KIT, Reorder #: DYNDH1632 Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. Class IIFDA’s classNov 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 2, 2022ClassClass IIStatusOngoingWhereNationwide, and California named
- Medical device recall MEDLINE PRE-OP CHG BATHING KIT Reorder #: P164756 Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. Class IIFDA’s classNov 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 2, 2022ClassClass IIStatusOngoingWhereNationwide, and California named
- Medical device recall EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for… Class IIFDA’s classNov 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 2, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, Florida, Illinois, Indiana, Kentucky and Texas named
- Medical device recall EMPOWER 3D Knee Tibial Insert Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for… Class IIFDA’s classNov 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 2, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, Florida, Illinois, Indiana, Kentucky and Texas named
- Medical device recall ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm impaired functionality of the release liner Class IIFDA’s classNov 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm impaired functionality of the release liner Class IIFDA’s classNov 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm impaired functionality of the release liner Class IIFDA’s classNov 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm impaired functionality of the release liner Class IIFDA’s classNov 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LINEAR 7.5Fr. 40cc IAB with Accessories (APA) The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal labels enclosed for hospital use. Class IIFDA’s classNov 2, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 2, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray Printed Instructions for Use (IFU) not shipped with device. Class IIFDA’s classNov 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedNov 2, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, District of Columbia, Indiana and Pennsylvania named
- Medical device recall da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC),… Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments installed on system 2) Force bipolar connected to Force… Class IIFDA’s classNov 2, 2022in FDA’s Enforcement Report27 statesnamed in where it went PublishedNov 2, 2022ClassClass IIStatusOngoingWhereAlaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, Nebraska, Nevada, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Washington and Wisconsin
- Medical device recall ARIES SARS-CoV-2 Assay A part defect with the wash 1 syringe of an SARS-CoV-2 assay could lead to incomplete extraction thereby producing an invalid or false negative assay result. Class IIFDA’s classNov 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Assigned vial lot numbers for the incorrect type of product. Class IIIFDA’s classNov 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall GORE CARDIOFORM ASD Occluder Due to manufacturing records (Release Test Results) indicating “Failed”. Class IIFDA’s classNov 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedNov 2, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Maine, Minnesota, North Carolina, New York, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A, CORA1810/B,… Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting when… Class IIFDA’s classNov 2, 2022in FDA’s Enforcement Report42 statesnamed in where it went PublishedNov 2, 2022ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall CorVocet Biopsy System Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting when… Class IIFDA’s classNov 2, 2022in FDA’s Enforcement Report42 statesnamed in where it went PublishedNov 2, 2022ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base The tibial tray lock detail is oversized (larger than specification). Class IIFDA’s classNov 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 2, 2022ClassClass IIStatusTerminatedWhereNationwide, and New York named
- Medical device recall Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base The tibial tray lock detail is oversized (larger than specification). Class IIFDA’s classNov 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 2, 2022ClassClass IIStatusTerminatedWhereNationwide, and New York named
- Medical device recall Iso-Gard Filter S Incidents of device splitting or detaching during use FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2022ClassClass IStatusOngoingWhereNationwide
- Medical device recall Iso-Gard Filter S, with Expandi-Flex Incidents of device splitting or detaching during use FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2022ClassClass IStatusOngoingWhereNationwide
- Medical device recall Iso-Gard Filter S, Tethered Cap Incidents of device splitting or detaching during use FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2022ClassClass IStatusOngoingWhereNationwide
- Medical device recall Iso-Gard Filter S, with Expandi-Flex, Tethered Cap Incidents of device splitting or detaching during use FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2022ClassClass IStatusOngoingWhereNationwide
- Medical device recall Iso-Gard Filter S with Expandi-Flex/Elbow: a) Incidents of device splitting or detaching during use FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2022ClassClass IStatusOngoingWhereNationwide
- Medical device recall Filter + Catheter Mount Incidents of device splitting or detaching during use FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2022ClassClass IStatusOngoingWhereNationwide
- Medical device recall Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material… Dimension Vista¿ High Density Lipoprotein Cholesterol (HDLC) Potential for Erroneous Result. Class IIFDA’s classOct 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ULTRASITE US04TL Smallbore T-Port Extension Set The extension set has a high probability of failure which could lead to possible leakage or detachment at the device’s bonded joint during use. Class IIFDA’s classOct 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Extension Set, EXT SET W/CARESITE, 6IN. The extension set has a high probability of failure which could lead to possible leakage or detachment at the device’s bonded joint during use. Class IIFDA’s classOct 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CARESITE SMALLBORE EXT SET T-PORT 5 IN. The extension set has a high probability of potential failure which could lead to possible leakage or detachment at the device’s bonded joint during use. Class IIFDA’s classOct 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number… N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF). Class IIFDA’s classOct 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number… N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF). Class IIFDA’s classOct 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg The affected product contains isobutylene which has recently demonstrated potential interference in determination of methanol by gas chromatography methods. Class IIFDA’s classOct 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Printing error on the device, size 3 Solus Standard laryngeal mask airway has been incorrectly marked with size 4 information (includes the number 4 as a size… Class IIFDA’s classOct 26, 2022in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 26, 2022ClassClass IIStatusTerminatedWhereOhio, Tennessee and Texas
- Medical device recall cobas 5800 instrument, Material No. 08707464001 Reported false positive and invalid results on the affected devices due to anomalous baselines. Class IIFDA’s classOct 26, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 26, 2022ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant… Class IIFDA’s classOct 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SPEED 15X12X12mm Continuous Compression Implant, Product No The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant… Class IIFDA’s classOct 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SPEED 9X10X10mm Continuous Compression Implant, Product No The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant… Class IIFDA’s classOct 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001 The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant… Class IIFDA’s classOct 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia. Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affected product incorrectly displays a double lumen 5.5 French… Class IIFDA’s classOct 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 26, 2022ClassClass IIStatusTerminatedWhereNationwide, and Florida named
- Medical device recall Optima Coil System Product pouch label does not match up with carton label Class IIFDA’s classOct 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 26, 2022ClassClass IIStatusOngoingWhereNationwide, and Florida, Georgia, North Carolina and Pennsylvania named
- Medical device recall Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401 Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. Class IIFDA’s classOct 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Atellica CH Lithium (Li), Siemens Material Number 11097535 Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. Class IIFDA’s classOct 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545 One lot of chest tube insertion trays, containing a silk suture component that is restricted to 1 cycle of sterilization, was processed though 2 cycles. Class IIFDA’s classOct 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 26, 2022ClassClass IIStatusTerminatedWhereNationwide, and California and Texas named
- Medical device recall Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification Class IIFDA’s classOct 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE05 Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification Class IIFDA’s classOct 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2022ClassClass IIStatusOngoingWhereNationwide
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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