Medical devices, 2020
Shortlist up to four to read them side by side.
3,055 medical device recalls FDA’s Enforcement Report published in 2020, 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.
3,055of 3,055 medical device recallsshown with your filters
The list
- Medical device recall FlexLab (FLX) with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10 Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has the potential to mis-associate sample IDs leading to incorrect… Class IIFDA’s classSep 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedSep 23, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Florida, Iowa, Louisiana, Massachusetts, Mississippi, Montana, North Carolina, Ohio, Texas and Virginia named
- Medical device recall Accelerator a3600 system with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10 Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has the potential to mis-associate sample IDs leading to incorrect… Class IIFDA’s classSep 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedSep 23, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Florida, Iowa, Louisiana, Massachusetts, Mississippi, Montana, North Carolina, Ohio, Texas and Virginia named
- Medical device recall Aptio Automation systems with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10 Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has the potential to mis-associate sample IDs leading to incorrect… Class IIFDA’s classSep 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedSep 23, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Florida, Iowa, Louisiana, Massachusetts, Mississippi, Montana, North Carolina, Ohio, Texas and Virginia named
- Medical device recall Model No:T-SPOT.TB8, Catalogue No.: TB.300 Incorrect expiration date included in test kit labeling and/or in Substrate component label. Class IIIFDA’s classSep 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedSep 23, 2020ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, Colorado, District of Columbia, Georgia, Idaho, Indiana, Maryland, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall Model No:T-SPOT.TB50, Catalogue No.: TB.50 Incorrect expiration date included in test kit labeling and/or in Substrate component label. Class IIIFDA’s classSep 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedSep 23, 2020ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, Colorado, District of Columbia, Georgia, Idaho, Indiana, Maryland, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem’s COVID-19 Interpretive Software v1.2 for 7500 RTPCR… COVID-19 Interpretive Software issues that may cause: 1) the risk of invalid or inconclusive tests/false negative and potentially increasing the retesting… Class IIFDA’s classSep 23, 2020in FDA’s Enforcement Report45 statesnamed in where it went PublishedSep 23, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, 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 and West Virginia
- Medical device recall The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem’s COVID-19 Interpretive Software v2.0 or v2.2 (used… COVID-19 Interpretive Software issues that may cause: 1) the risk of invalid or inconclusive tests/false negative and potentially increasing the retesting… Class IIFDA’s classSep 23, 2020in FDA’s Enforcement Report45 statesnamed in where it went PublishedSep 23, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, 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 and West Virginia
- Medical device recall The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer… As a result of the release of new software version to CareLink Personal website, the IOS app for the Continuous Monitoring Glucose system stopped automatically… Class IIFDA’s classSep 23, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 23, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602 Recent internal verification studies found the current RF interference claim to no longer be met for the assay on the cobas e 411, 601, and 602 analyzers. Class IIFDA’s classSep 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Alaris System The Alaris PC unit can display incorrect syringe type and/or syringe sizes. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 16, 2020in FDA’s Enforcement Report54 statesnamed in where it went PublishedSep 16, 2020ClassClass IStatusOngoingWhereAlaska, Alabama, Arkansas, American Samoa, 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, Northern Mariana Islands, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Alaris System PC Unit The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 16, 2020in FDA’s Enforcement Report52 statesnamed in where it went PublishedSep 16, 2020ClassClass IStatusOngoingWhereAlaska, 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, Northern Mariana Islands, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY CASE FRONT W/KEYPAD 8015LS, TC10010217 ASSY… The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 16, 2020in FDA’s Enforcement Report52 statesnamed in where it went PublishedSep 16, 2020ClassClass IStatusOngoingWhereAlaska, 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, Northern Mariana Islands, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall SINGLES Carbide US-No US-dates between the product package label and the bar code display. Class IIFDA’s classSep 16, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedSep 16, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Indiana, New York, Pennsylvania and Texas named
- Medical device recall QIAstat-Dx Respiratory SARS-CoV-2 Panel There is an increased rate of potential false positive results for the Influenza A (no subtype) target, which may lead to 1) inappropriate antiviral use, 2)… Class IIFDA’s classSep 16, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedSep 16, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, District of Columbia, Delaware, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Minnesota, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Texas and Washington named
- Medical device recall BD Alaris System PC Unit Pump Module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion or… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 16, 2020in FDA’s Enforcement Report54 statesnamed in where it went PublishedSep 16, 2020ClassClass IStatusOngoingWhereAlaska, 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, Northern Mariana Islands, 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 Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Kits were packaged with the incorrect size valve peelable introducer. Class IIFDA’s classSep 16, 2020in FDA’s Enforcement Report12 statesnamed in where it went PublishedSep 16, 2020ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, North Carolina, North Dakota, New Jersey, New York, Ohio, Pennsylvania, Virginia and Washington
- Medical device recall Talladium Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1, Shaded Zirconia Blend 2.0 50# A1 The linear shrinkage on the zirconia blank disc s part label is incorrect. Class IIFDA’s classSep 16, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedSep 16, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Kansas, Louisiana, Missouri and Pennsylvania named
- Medical device recall Merge PACS Measurements done on the Merge PACS generated MPR s may have incorrect measurements. Class IIFDA’s classSep 16, 2020in FDA’s Enforcement Report25 statesnamed in where it went PublishedSep 16, 2020ClassClass IIStatusTerminatedWhereArkansas, California, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Mexico, New York, Ohio, South Carolina, Texas, Utah, Virginia and Wisconsin
- Medical device recall EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicated for fracture fixation,… Multiple or incorrect expiration dates were provided on the affected designation labels. Class IIFDA’s classSep 16, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 16, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a… Label has the incorrect size for the tracheotomy tube. Class IIFDA’s classSep 16, 2020in FDA’s Enforcement ReportConnecticutthe one state its words name PublishedSep 16, 2020ClassClass IIStatusTerminatedWhereConnecticut
- Medical device recall PROFEMUR Titanium and Cobalt Chrome modular necks MicroPort Orthopedics Inc. Class IIFDA’s classSep 16, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedSep 16, 2020ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Missouri, Montana, North Carolina, New Hampshire, New Jersey, Nevada, Ohio, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845. One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating… Class IIFDA’s classSep 16, 2020in FDA’s Enforcement Report12 statesnamed in where it went PublishedSep 16, 2020ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Illinois, Massachusetts, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Texas and Virginia
- Medical device recall ION Reprocessing Accessories Kit, IF1000 (Part Number: 490024-03) UDI:00886874119129 One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating… Class IIFDA’s classSep 16, 2020in FDA’s Enforcement Report12 statesnamed in where it went PublishedSep 16, 2020ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Illinois, Massachusetts, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Texas and Virginia
- Medical device recall SICAT IMPLANT V2.0 A dentist found implant positions are not correctly exported from the implant planning software SICAT IMPLANT V2.0 - for the specific export format CMG.DXD. Class IIFDA’s classSep 16, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 16, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic,… GEHC Surgery became aware that some users of the 9800 and 9900 fluoroscopic mobile C-Arms (referred to as the system here on) within the United States had… Class IIFDA’s classSep 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Plastic Cannula HOLDEX Sample leaking from the sleeve covering the needle inside the cannula Class IIFDA’s classSep 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 9, 2020ClassClass IIStatusOngoingWhereNationwide, and Tennessee and Utah named
- Medical device recall PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage: This surgeon s glove is a disposable device… A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. Class IIFDA’s classSep 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2020ClassClass IIStatusCompletedWhereNationwide
- Medical device recall PROTEXIS Latex Micro Surgical Gloves Size 6.0 - Product Usage: This surgeon s glove is a disposable device… A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. Class IIFDA’s classSep 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2020ClassClass IIStatusCompletedWhereNationwide
- Medical device recall PROTEXIS Latex Micro Surgical Gloves Size 6.5 - Product Usage: This surgeon s glove is a disposable device… A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. Class IIFDA’s classSep 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2020ClassClass IIStatusCompletedWhereNationwide
- Medical device recall PROTEXIS Latex Micro Surgical Gloves Size 7.0 - Product Usage: This surgeon s glove is a disposable device… A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. Class IIFDA’s classSep 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2020ClassClass IIStatusCompletedWhereNationwide
- Medical device recall PROTEXIS Latex Micro Surgical Gloves Size 7.5 - Product Usage: This surgeon s glove is a disposable device… A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. Class IIFDA’s classSep 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2020ClassClass IIStatusCompletedWhereNationwide
- Medical device recall PROTEXIS Latex Micro Surgical Gloves Size 8.0 - Product Usage: This surgeon s glove is a disposable device… A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. Class IIFDA’s classSep 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2020ClassClass IIStatusCompletedWhereNationwide
- Medical device recall PROTEXIS Latex Micro Surgical Gloves Size 8.5 - Product Usage: This surgeon s glove is a disposable device… A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. Class IIFDA’s classSep 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2020ClassClass IIStatusCompletedWhereNationwide
- Medical device recall PROTEXIS Latex Micro Surgical Gloves Size 9.0 - Product Usage: This surgeon s glove is a disposable device… A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. Class IIFDA’s classSep 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2020ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Thermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Number: R30165501, UDI-DI:… Thermo Scientific” Remel” Bordetella pertussis Agglutinating Serum (R30165501/ZM10) is not performing, resulting in the potential for false negative results… Class IIFDA’s classSep 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 9, 2020ClassClass IIStatusTerminatedWhereNationwide, and California and Missouri named
- Medical device recall Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative… The connector linking the EtCO2 module to the HemoBox may break and become damaged, if the connector is re-attached to the HemoBox in this damaged state, under… Class IIFDA’s classSep 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pleur-evac Thoracic Catheters Potential sterility issue Class IIFDA’s classSep 9, 2020in FDA’s Enforcement Report27 statesnamed in where it went PublishedSep 9, 2020ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Michigan, Minnesota, Mississippi, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the quoted performance claims prior to expiry on 28th Sept 2020. Class IIFDA’s classSep 9, 2020in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 9, 2020ClassClass IIStatusTerminatedWhereMassachusetts, New Mexico and West Virginia
- Medical device recall Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked-pNPG7 Reagent Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the quoted performance claims prior to expiry on 28th Sept 2020. Class IIFDA’s classSep 9, 2020in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 9, 2020ClassClass IIStatusTerminatedWhereMassachusetts, New Mexico and West Virginia
- Medical device recall Cirq Arm System Holding force of the Positioning Arm can be reduced by prolonged non-use. Class IIFDA’s classSep 9, 2020in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 9, 2020ClassClass IIStatusTerminatedWhereDistrict of Columbia, Illinois and Ohio
- Medical device recall The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm. The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm, were found to have a labeling error. Class IIFDA’s classSep 9, 2020in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 9, 2020ClassClass IIStatusOngoingWhereColorado, Florida, Oklahoma and Pennsylvania
- Medical device recall Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the… Dimension Vista High Sensitivity Troponin I (TNIH) may exhibit a negative bias with patient samples Class IIFDA’s classSep 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall StimQ Peripheral Nerve Stimulator System (PNS) The product contains a non-functional component not referenced in product labeling. Class IIFDA’s classSep 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedSep 9, 2020ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall StimQ Peripheral Nerve Stimulator System (PNS) The product contains a non-functional component not referenced in product labeling. Class IIFDA’s classSep 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedSep 9, 2020ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall StimQ Peripheral Nerve Stimulator System (PNS) Models: 1 The product contains a non-functional component not referenced in product labeling. Class IIFDA’s classSep 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedSep 9, 2020ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US - Product Usage: is used for peripheral… The product contains a non-functional component not referenced in product labeling. Class IIFDA’s classSep 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedSep 9, 2020ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall StimQ Peripheral Nerve Stimulator System (PNS) The product contains a non-functional component not referenced in product labeling. Class IIFDA’s classSep 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedSep 9, 2020ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall StimQ Peripheral Nerve Stimulator System (PNS) Models: 1 The product contains a non-functional component not referenced in product labeling. Class IIFDA’s classSep 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedSep 9, 2020ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin 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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