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 6, 2026.
2,192of 2,192 medical device recallsshown with your filters
The list
- Medical device recall Tempus LS, Type DGE1, CAT 00-3010 Distribution of Defibrillators that are not approved or cleared for distribution US Market. Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 13, 2022ClassClass IIStatusTerminatedWhereNationwide, and Illinois and Kansas named
- Medical device recall Surgicare Neuro Pack - Neurological Kit The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit. Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedApr 13, 2022ClassClass IIStatusOngoingWhereNationwide, and Indiana, Pennsylvania and Texas named
- Medical device recall Lum Lam Custom Pack - Anesthesia Kit The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit. Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedApr 13, 2022ClassClass IIStatusOngoingWhereNationwide, and Indiana, Pennsylvania and Texas named
- Medical device recall Total Knee Pack - Surgical Kit The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit. Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedApr 13, 2022ClassClass IIStatusOngoingWhereNationwide, and Indiana, Pennsylvania and Texas named
- Medical device recall Anterior Hip Pack - Surgical Kit The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit. Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedApr 13, 2022ClassClass IIStatusOngoingWhereNationwide, and Indiana, Pennsylvania and Texas named
- Medical device recall Coryell Memorial Hosp Total, Joint Pack - Surgical Kit The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit. Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedApr 13, 2022ClassClass IIStatusOngoingWhereNationwide, and Indiana, Pennsylvania and Texas named
- Medical device recall MODEL: X-RAY R/F SYSTEM FLUOROspeed X1 It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to… Class IIFDA’s classApr 13, 2022in FDA’s Enforcement Report37 statesnamed in where it went PublishedApr 13, 2022ClassClass IIStatusOngoingWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Washington and West Virginia
- Medical device recall MODEL: X-RAY TV SYSTEM SONIALVISION G4 It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to… Class IIFDA’s classApr 13, 2022in FDA’s Enforcement Report37 statesnamed in where it went PublishedApr 13, 2022ClassClass IIStatusOngoingWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Washington and West Virginia
- Medical device recall MODEL: X-RAY TV SYSSTEM SONIALVISION safire17 It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to… Class IIFDA’s classApr 13, 2022in FDA’s Enforcement Report37 statesnamed in where it went PublishedApr 13, 2022ClassClass IIStatusOngoingWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Washington and West Virginia
- Medical device recall Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and… Cybersecurity Improvement Action-not equipped against potential cyber security threats Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ventilation neonatal patients from… Cybersecurity Improvement Action-not equipped against potential cyber security threats Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion… Due to a software defect, the Philips StentBoost Live R2.0 might not process X-ray images of the current run and instead show an image processed in a previous… Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events Class IIIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Cook Celect PlatinumVena Cava Filter Set IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events Class IIIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Panther Fusion GBS Assay Cartridges 96 Tests Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results. Class IIFDA’s classApr 13, 2022in FDA’s Enforcement Report21 statesnamed in where it went PublishedApr 13, 2022ClassClass IIStatusOngoingWhereArkansas, California, Connecticut, Florida, Illinois, Indiana, Massachusetts, Michigan, New Hampshire, New Jersey, Nevada, New York, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Virginia, Washington and West Virginia
- Medical device recall DeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic (chlorhexidine gluconate and… A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products. Class IIFDA’s classApr 13, 2022in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 13, 2022ClassClass IIStatusTerminatedWhereFlorida, New Jersey and Tennessee
- Medical device recall DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol)… A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products. Class IIFDA’s classApr 13, 2022in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 13, 2022ClassClass IIStatusTerminatedWhereFlorida, New Jersey and Tennessee
- Medical device recall DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl… A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products. Class IIFDA’s classApr 13, 2022in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 13, 2022ClassClass IIStatusTerminatedWhereFlorida, New Jersey and Tennessee
- Medical device recall Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS There is a potential for AED pads to experience gel separation from the foam/tin backing when peeled from the plastic liner. Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 13, 2022ClassClass IIStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS CARTRIDGE , (0-8 YEARS) <55… There is a potential for AED pads to experience gel separation from the foam/tin backing when peeled from the plastic liner. Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 13, 2022ClassClass IIStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Alinity m HBV Application Specification File (US and CE) There is a potential for misquantitation high results of negative samples. Class IIFDA’s classApr 13, 2022in FDA’s Enforcement Report14 statesnamed in where it went PublishedApr 13, 2022ClassClass IIStatusOngoingWhereArizona, California, Illinois, Indiana, Massachusetts, Michigan, Missouri, New Hampshire, New Jersey, New York, Ohio, South Dakota, Texas and Virginia
- Medical device recall Alinity m HBV AMP Kit (US and CE) There is a potential for misquantitation high results for negative samples. Class IIFDA’s classApr 13, 2022in FDA’s Enforcement Report14 statesnamed in where it went PublishedApr 13, 2022ClassClass IIStatusOngoingWhereArizona, California, Illinois, Indiana, Massachusetts, Michigan, Missouri, New Hampshire, New Jersey, New York, Ohio, South Dakota, Texas and Virginia
- Medical device recall SyncVision Systems If FFR measurement(s) are made prior to an iFR/FFR co-registration/pullback in the same procedural session, this could result in incorrect iFR/FFR… Class IIFDA’s classApr 13, 2022in FDA’s Enforcement Report45 statesnamed in where it went PublishedApr 13, 2022ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001 Potential for corrosion on the pins of the Ultima Activator II Reusable Drive Mechanism. Class IIFDA’s classApr 13, 2022in FDA’s Enforcement Report14 statesnamed in where it went PublishedApr 13, 2022ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Florida, Illinois, Kentucky, Louisiana, Missouri, Montana, New Mexico, Ohio, Pennsylvania, Texas and Wisconsin
- Medical device recall Brius Pontics (components in a set of custom metal orthodontic devices);BRIUS Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented,… Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedApr 13, 2022ClassClass IIStatusTerminatedWhereNationwide, and California, District of Columbia, Massachusetts, New Jersey, New York and Texas named
- Medical device recall Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices) Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented,… Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedApr 13, 2022ClassClass IIStatusTerminatedWhereNationwide, and California, District of Columbia, Massachusetts, New Jersey, New York and Texas named
- Medical device recall Customized Brius Appliances (custom metal orthodontic devices) Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented,… Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedApr 13, 2022ClassClass IIStatusTerminatedWhereNationwide, and California, District of Columbia, Massachusetts, New Jersey, New York and Texas named
- Medical device recall ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the… This calibrator lot did not meet acceptance criteria during ongoing stability testing. Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall First SIGN SARS-CoV-2 Antigen Test Frm became aware that a customer complaint was reported to US FDA that SARS-CoV-2 Antigen Tests were sold domestically by a pharmacy in California. Class IIFDA’s classApr 13, 2022in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 13, 2022ClassClass IIStatusTerminatedWhereCalifornia, Florida, Louisiana, Massachusetts and Texas
- Medical device recall Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue. Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 13, 2022ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BenchMark ULTRA and DISCOVERY ULTRA Instruments Potential for Fluid Leak inside a staining system that could cause an electrical short circuit of the General Purpose Input/ Output Board’s J1 Connector that… Class IIFDA’s classApr 13, 2022in FDA’s Enforcement Report52 statesnamed in where it went PublishedApr 13, 2022ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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 Amplatzer Steerable Delivery Sheath Instructions for use were updated. Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 13, 2022ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedApr 13, 2022ClassClass IIStatusTerminatedWhereNew York
- Medical device recall Cardiohelp-i Transport Guard with Transport Guard Potential for a loose cylindrical pin on the Transport Guard that may result in the jamming of the locking mechanism causing the Transport Guard to not open… Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedApr 13, 2022ClassClass IIStatusOngoingWhereNationwide, and Florida, Kentucky, New Hampshire, New Jersey, New York, Pennsylvania, Texas and Virginia named
- Medical device recall Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP Sterility failure of the exterior of the syringe which may impact the device’s ability to be laid on a sterile field. Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedApr 13, 2022ClassClass IIStatusTerminatedWhereNationwide, and Kentucky, Oklahoma and Texas named
- Medical device recall CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179 Retinal analysis system software has some features, based on artificial intelligence, that potentially lack appropriate market approval, so it is recommended… Class IIFDA’s classApr 6, 2022in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedApr 6, 2022ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808) Malfunction of the hand pendant controlling movement of the therapy couch and nozzle may result in unintentional motion. Class IIFDA’s classApr 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedApr 6, 2022ClassClass IIStatusOngoingWhereNationwide, and District of Columbia, Florida, Missouri, New Jersey, Ohio, Oklahoma and Utah named
- Medical device recall cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190 Roche has identified a small number of cobas Liat analyzer units that have consistently high noise levels (background signal) originating from the amber… Class IIFDA’s classApr 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedApr 6, 2022ClassClass IIStatusOngoingWhereNationwide, and Colorado, Illinois, Indiana, Kentucky, Michigan, North Carolina and Texas named
- Medical device recall Liko Universal Twinbar 670 QRH, an accessory that can be used together with most Liko lifts An incorrect center bolt was used in the assembly of the product which could result in a patient fall during use. Class IIFDA’s classApr 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedApr 6, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158 Dimension Vista Magnesium Flex reagent cartridge lots exhibiting imprecision and intermittent Abnormal Assay flags. Class IIFDA’s classApr 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedApr 6, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, 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, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall MiniCap Extended Life PD Transfer Set Devices distributed lacked regulatory clearance. Class IIFDA’s classApr 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedApr 6, 2022ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, District of Columbia, Delaware, Florida, Georgia, Illinois, Louisiana, Michigan, Missouri, New Mexico, New York, Ohio, Oklahoma, Pennsylvania and Texas named
- Medical device recall Nimbus PainPro Ambulatory Infusion Pumps with software version v4 An unreleased Version 4 Protocol Library was installed on Nimbus PainPro (H) infusion pumps in error that may impact patient safety if used on patients. Class IIFDA’s classApr 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 6, 2022ClassClass IIStatusOngoingWhereNationwide, and North Carolina and Ohio named
- Medical device recall (a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7”, 17.5 cm The finished device package did not contain the IFU. Class IIFDA’s classApr 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedApr 6, 2022ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Minnesota, Mississippi, Montana, North Carolina, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall FORE-SIGHT ELITE Absolute Tissue Oximeter The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor… Class IIFDA’s classApr 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedApr 6, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, 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, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall FORE-SIGHT ELITE Tissue Oximeter module The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor… Class IIFDA’s classApr 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedApr 6, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, 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, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories The photomultiplier tube, may have compromised functionality in some instruments. Class IIFDA’s classApr 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedApr 6, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Wisconsin and West Virginia named
- Medical device recall Regard Custom Procedure Kits containing BD Luer Lok Access Devices Recalled devices were packaged in convenience kits. Class IIIFDA’s classApr 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 6, 2022ClassClass IIIStatusTerminatedWhereNationwide, and Missouri named
- Medical device recall Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2 Transport company failed to stop at the border for required FDA inspection. Class IIFDA’s classApr 6, 2022in FDA’s Enforcement Report6 statesnamed in where it went PublishedApr 6, 2022ClassClass IIStatusOngoingWhereArizona, California, Nevada, Texas, Utah and Washington
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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