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 Professional Artificial Intrauterine Insemination Kit (SKU 636391205986) Device was distributed without a proper marketing authorization. Class IIFDA’s classApr 14, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 14, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Professional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205962, 636391206013) Device was distributed without a proper marketing authorization. Class IIFDA’s classApr 14, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 14, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Pro Series Fertility Device (SKU 644042788139) Device was distributed without a proper marketing authorization. Class IIFDA’s classApr 14, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 14, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Professional At Home Artificial Intrauterine Insemination Set (SKU 644042787811) Device was distributed without a proper marketing authorization. Class IIFDA’s classApr 14, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 14, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve Non-conformity (holes/punctures or deep creases) in the sterile barrier. Class IIFDA’s classApr 14, 2021in FDA’s Enforcement Report6 statesnamed in where it went PublishedApr 14, 2021ClassClass IIStatusTerminatedWhereArizona, Florida, Michigan, Ohio, Texas and Wisconsin
- Medical device recall Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick… There is a potential for the stainless steel locking plates on the device’s sternal retractor locking mechanism to fracture. Class IIFDA’s classApr 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedApr 14, 2021ClassClass IIStatusTerminatedWhereNationwide, and Maryland, New Hampshire, New Jersey, Nevada, Pennsylvania, Tennessee and Wisconsin named
- Medical device recall A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC There are two issues within this correction action: 1. Class IIFDA’s classApr 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 14, 2021ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Panther Fusion Tube Tray There is a potential for tube trays to leak which could potentially result in false positive results, false negative results or invalid patient results. Class IIFDA’s classApr 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedApr 14, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall MicroScan WalkAway-40 plus Instrument Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification… Class IIFDA’s classApr 14, 2021in FDA’s Enforcement Report15 statesnamed in where it went PublishedApr 14, 2021ClassClass IIStatusTerminatedWhereColorado, Florida, Illinois, Indiana, Kentucky, Maine, Michigan, Mississippi, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Virginia and Washington
- Medical device recall MicroScan WalkAway-96 plus Instrument Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification… Class IIFDA’s classApr 14, 2021in FDA’s Enforcement Report15 statesnamed in where it went PublishedApr 14, 2021ClassClass IIStatusTerminatedWhereColorado, Florida, Illinois, Indiana, Kentucky, Maine, Michigan, Mississippi, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Virginia and Washington
- Medical device recall MicroScan WalkAway-40 plus Reconditioned Instrument Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification… Class IIFDA’s classApr 14, 2021in FDA’s Enforcement Report15 statesnamed in where it went PublishedApr 14, 2021ClassClass IIStatusTerminatedWhereColorado, Florida, Illinois, Indiana, Kentucky, Maine, Michigan, Mississippi, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Virginia and Washington
- Medical device recall MicroScan WalkAway-96 plus Reconditioned Instrument Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification… Class IIFDA’s classApr 14, 2021in FDA’s Enforcement Report15 statesnamed in where it went PublishedApr 14, 2021ClassClass IIStatusTerminatedWhereColorado, Florida, Illinois, Indiana, Kentucky, Maine, Michigan, Mississippi, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Virginia and Washington
- Medical device recall Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy Difficulty inserting the biopsy ejector rod into the bone lesion biopsy cannula, preventing the biopsy sample from being collected. Class IIFDA’s classApr 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 14, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Regard, Item Number 830067009, custom cardiovascular procedure kit ROi CPS, LLC has become aware, through a vendor issued urgent medical device recall notice, that drapes contained within select Regard customer procedure trays… Class IIFDA’s classApr 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 14, 2021ClassClass IIStatusOngoingWhereNationwide, and Missouri named
- Medical device recall BD BBL Martin-Lewis Agar, 100 Ea - Product Usage: used for the isolation of pathogenic Neisseria from… Products show heavy growth of C. Class IIFDA’s classApr 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 14, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD BBL Martin-Lewis Agar 20 Ea - Product Usage: use for the isolation of pathogenic Neisseria from specimens… Products show heavy growth of C. Class IIFDA’s classApr 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 14, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System,… The posterior condyle of the Specialty Triathlon TS Trial Cutting Guide(s), sizes 1 through 8, (Left and Right) has the potential to fracture at the augment… Class IIFDA’s classApr 14, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedApr 14, 2021ClassClass IIStatusTerminatedWhereCalifornia, Georgia, North Carolina, New Jersey, Nevada, Oklahoma and Texas
- Medical device recall ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal… Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 7, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal… Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 7, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal… Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 7, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR, Evera S DR, Evera MRI XT DR,… A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 7, 2021ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viva family:… A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 7, 2021ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall BD Alaris Infusion Pump Module Pump Module keypad lifting, and Fluid ingress could result in 1) Unresponsive keys: module continues infusion, PC unit will not alarm and must be used for… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 7, 2021ClassClass IStatusOngoingWhereNationwide
- Medical device recall Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures. The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color. Class IIFDA’s classApr 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedApr 7, 2021ClassClass IIStatusTerminatedWhereNationwide, and Ohio, Oregon, Tennessee and Texas named
- Medical device recall Vertical Drain Tube Attachment Device (VTAD) (Gastrointestinal tube and accessories) - Product Usage:… The tube holder can separate from the barrier that secures the device to the patients’ body. Class IIFDA’s classApr 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedApr 7, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and West Virginia named
- Medical device recall Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of the… Two lots of test strips failed QC testing using blank buffer due to false positives. Class IIFDA’s classApr 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 7, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console An electrical component within the system controller module of certain Bio-Console 560 devices may exhibit electrical failure causing the device to stop… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 7, 2021ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. Class IIFDA’s classApr 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedApr 7, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of three… Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. Class IIFDA’s classApr 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedApr 7, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall The ATTUNE¿ Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple components… Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. Class IIFDA’s classApr 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedApr 7, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall EPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm),… It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. Class IIFDA’s classApr 7, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 7, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall EPIX Therapeutics DiamondTemp Unidirectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm),… It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. Class IIFDA’s classApr 7, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 7, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall EPIX Therapeutics DiamondTemp Bidrectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector… It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. Class IIFDA’s classApr 7, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 7, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector… It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. Class IIFDA’s classApr 7, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 7, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Small Curve, 7.5 French Size(2.48 mm),… It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. Class IIFDA’s classApr 7, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 7, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Large Curve, 7.5 French Size(2.48 mm),… It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. Class IIFDA’s classApr 7, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 7, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall PRECICE STRYDE - Product Usage: intended for limb lengthening, open and closed fracture fixation,… Due to complaints of adverse events potentially related to biological safety. Class IIFDA’s classApr 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 7, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Precice Bone Transport - Product Usage: intended for limb lengthening, open and closed fracture fixation,… Due to complaints of adverse events potentially related to biological safety. Class IIFDA’s classApr 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 7, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PRECICE PLATE - Product Usage: intended for limb lengthening, open and closed fracture fixation,… Due to complaints of adverse events potentially related to biological safety. Class IIFDA’s classApr 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 7, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring, recording and alarming… Fail to Comply with Chinese Standard YY1079-2008: Clauses 4.2.6 and 4.2.7.3. Class IIFDA’s classApr 7, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 7, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Stryker Sustainability Solutions Product was distributed without receiving regulatory clearance. Class IIFDA’s classApr 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 7, 2021ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall Alcon Custom Ophthalmic Surgical Procedure Packs Reports have been received concerning mold found on gowns included in custom ophthalmic surgery packages. Class IIFDA’s classApr 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 7, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall AngioDynamics SafeSheath ULTRALITE 10F Potential for open seal on sterile product Class IIFDA’s classApr 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 7, 2021ClassClass IIStatusTerminatedWhereNationwide, and New York named
- Medical device recall Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** The ultrasound system averages the Mean Sac Diameter (MSD) and Gestational Sac Diameter (GSD) into the Estimated Date of Delivery (EDD) calculation. Class IIFDA’s classApr 7, 2021in FDA’s Enforcement Report44 statesnamed in where it went PublishedApr 7, 2021ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument Their is a potential that the automated staining instrument with software version 3.5.3.1 may move with random speeds in random direction across its range of… Class IIFDA’s classApr 7, 2021in FDA’s Enforcement Report15 statesnamed in where it went PublishedApr 7, 2021ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Connecticut, Florida, Illinois, Massachusetts, Maryland, Minnesota, North Carolina, Ohio, Oregon, Pennsylvania, Washington and Wyoming
- Medical device recall CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to be used for gastroesophageal pH… The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the capsule. Class IIFDA’s classApr 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 7, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended to be used for gastroesophageal… The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the capsule. Class IIFDA’s classApr 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 7, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immunoassay (CLIA) intended for the… Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples. Class IIFDA’s classApr 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedApr 7, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Kentucky, Ohio and Pennsylvania 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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