Medical devices, 2014
Shortlist up to four to read them side by side.
3,059 medical device recalls FDA’s Enforcement Report published in 2014, 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 7, 2026.
3,059of 3,059 medical device recallsshown with your filters
The list
- Medical device recall iLab Ultrasound Imaging System Specific iLab Ultrasound Imaging Systems using newest 3.0 (Polaris 1.0) software change the pullback speed from the default setting of 0.5 mm/sec to 1.0… Class IIFDA’s classApr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedApr 30, 2014ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Florida, North Carolina, New York and Pennsylvania named
- Medical device recall GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use in cardiac imaging. GE Healthcare has recently become aware of a potential safety issue where the probe power surveillance settings for 4 probes (C1-5-D, C2-9-D, IC5-9-D and… Class IIFDA’s classApr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedApr 30, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Georgia, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Montana, New Mexico, Nevada, New York, Ohio, Texas, Virginia and Wisconsin named
- Medical device recall ev3 EverCross 0.035” OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm Covidien is recalling 2 production lots of EverCross 0.035 PTA Balloon Catheter because of a product labeling error. Class IIFDA’s classApr 30, 2014in FDA’s Enforcement Report6 statesnamed in where it went PublishedApr 30, 2014ClassClass IIStatusTerminatedWhereIndiana, North Carolina, New York, Oklahoma, Texas and West Virginia
- Medical device recall VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168 Customers were unable to calibrate, or use previously calibrated, VITROS DT CRSC slides (REF/Product Code 6802721), GEN 82, on the VITROS DT II System, when… Class IIFDA’s classApr 30, 2014in FDA’s Enforcement Report10 statesnamed in where it went PublishedApr 30, 2014ClassClass IIStatusTerminatedWhereArkansas, Florida, Iowa, Illinois, Kentucky, Michigan, Minnesota, North Dakota, New York and Virginia
- Medical device recall The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is an Analyte Specific Reagent (ASR)… 20 kits of CEP 8 SG ASR Probe (list 06J37-018, lot 440023), contained Vysis CEP 4 (Alpha Satellite) SG Probe, 20u, (part 32-112004 lot 438814), instead of the… Class IIIFDA’s classApr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedApr 30, 2014ClassClass IIIStatusTerminatedWhereNationwide, and California, Colorado, Connecticut, Florida, Hawaii, Illinois, Indiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116 Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculation in case of beam line option other than Zero (0). Class IIFDA’s classApr 30, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedApr 30, 2014ClassClass IIStatusTerminatedWhereIllinois, New Jersey, Oklahoma and Washington
- Medical device recall Stryker PenAdapt” During packaging verification testing, a failure occurred due to cuts in the packaging potentially causing a breach in the sterile barrier. Class IIFDA’s classApr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedApr 30, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number CDC-35052-VPS, peripherally… Kits are packaged with the incorrect catheter. Class IIFDA’s classApr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for receiving,… Philips MDC PACS Release R2.x and Philips IntelliSpace PACS DCX R3.x, may have incorrect density measurement on Enhanced CT/MR examinations Class IIFDA’s classApr 30, 2014in FDA’s Enforcement Report7 statesnamed in where it went PublishedApr 30, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, New Jersey, Oklahoma, Puerto Rico and Washington
- Medical device recall TRABECULAR METAL MODULAR ACETABULAR SYSTEM, Shell with Cluster Holes, Porous 60mm The shell was missing the locking ring. Class IIFDA’s classApr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedApr 30, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Georgia, Illinois, Maine, North Carolina, New Jersey, New York, Pennsylvania, Texas and Wisconsin named
- Medical device recall Monofilament and Multifilament Non-absorbable Steel Suture The products are being recalled because they did not meet minimum diameter requirements. Class IIFDA’s classApr 30, 2014in FDA’s Enforcement Report8 statesnamed in where it went PublishedApr 30, 2014ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Indiana, Kentucky, Massachusetts, New Mexico and Pennsylvania
- Medical device recall Amo-O Herbal Stimulator, 2 fl Firm is not registered as a drug manufacturer. Class IIFDA’s classApr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedApr 30, 2014ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Kentucky, Louisiana, Michigan, North Carolina, Nebraska, Nevada, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah and Virginia named
- Medical device recall Mega-Gen His Personal Lubricant, 8 fl Firm is not registered as a drug manufacturer. Class IIFDA’s classApr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedApr 30, 2014ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Kentucky, Louisiana, Michigan, North Carolina, Nebraska, Nevada, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah and Virginia named
- Medical device recall Nice-En-Smooth Berry Burst, 4 oz. Firm is not registered as a drug manufacturer. Class IIFDA’s classApr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedApr 30, 2014ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Kentucky, Louisiana, Michigan, North Carolina, Nebraska, Nevada, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah and Virginia named
- Medical device recall Hot Ice, 1 fl Firm is not registered as a drug manufacturer. Class IIFDA’s classApr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedApr 30, 2014ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Kentucky, Louisiana, Michigan, North Carolina, Nebraska, Nevada, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah and Virginia named
- Medical device recall On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ’’Type 01” elbow motors Varian has identified a failure with the shaft of the Type 01 elbow motor for Exact arms used in the On-Board Imager (OBI) device due to belt over-tensioning. Class IIFDA’s classApr 30, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 30, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Digital Diagnost, stationary radiographic system The footboard of Patient support for stitching can be fixed in upper position. Class IIFDA’s classApr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedApr 30, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont and Wyoming named
- Medical device recall Siemens ACUSON X700 Ultrasound Systems with software version 1.0.00, 1.0.01, 1.0.02, 1.1.00 and 1.1.02 When fourSight 4D ultrasound imaging, 3-Scrape real time 3D imaging, or Anatomical M-mode are used during an Obstetric or Gynecology study, data from the… Class IIFDA’s classApr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MULTIX FUSION It was observed that the corrugated hose holder above the 3D rail on the Multix Fusion system became loose. Class IIFDA’s classApr 30, 2014in FDA’s Enforcement Report8 statesnamed in where it went PublishedApr 30, 2014ClassClass IIStatusTerminatedWhereAlaska, Florida, Kentucky, Michigan, New York, Ohio, Pennsylvania and Wisconsin
- Medical device recall Sengstaken Tube and Sengstaken-Blakemore Tube Sterility of the product cannot be guaranteed. Class IIFDA’s classApr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedApr 30, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalogue number AK-45854-CDC. Arrow is recalling the Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter due to a labeling inconsistency. Class IIFDA’s classApr 30, 2014in FDA’s Enforcement Report12 statesnamed in where it went PublishedApr 30, 2014ClassClass IIStatusTerminatedWhereArizona, Delaware, Georgia, Iowa, Illinois, Louisiana, Michigan, North Carolina, Oregon, Pennsylvania, Virginia and West Virginia
- Medical device recall ToxCup Drug Screen Cup, Catalogue Numbers: HT15, HT15A, PT11, PT11A, PT15A, PT23A, a screening device for the… May be labeled with incorrect result interpretation graphics on the ToxCup lid label. Class IIFDA’s classApr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Monodek Violet Synthetic Absorbable Surgical Sutures, MF 0 TC43/HR26 48 Product does not meet minimum knot tensile strength requirements. Class IIFDA’s classApr 30, 2014in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedApr 30, 2014ClassClass IIStatusTerminatedWhereMassachusetts
- Medical device recall SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 23, 2014ClassClass IStatusTerminatedWhereNationwide, and North Carolina and South Carolina named
- Medical device recall Pipeline Embolization Device (PED) Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 23, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Alligator Retrieval Device (ARD) Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 23, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Gambro Cartridge Blood Set, blood transport system for hemodialysis Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets. Class IIFDA’s classApr 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Synthes CMF Battery Powered Driver The CMF Battery Powered Driver graphic case contains outlines of the Battery Powered Driver, taps, screwdriver blades, and a screw holding sleeve. Class IIFDA’s classApr 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm Product Usage: Used to expose bone for… The Synthes Hohmann Retractor was mis-etched on the product and package as part number 399.24 instead of part number 399.22. Class IIFDA’s classApr 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedApr 23, 2014ClassClass IIStatusTerminatedWhereNationwide, and Indiana, Maryland, New Jersey, New York, Tennessee, Virginia and Washington named
- Medical device recall BIOMET 3i Endosseous Dental Implant. Due to residual machining fluid identified by discoloration (darker in appearance) on the external dental implant surface. Class IIFDA’s classApr 23, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 23, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SmartSite Extension Set Disconnections and leakages at the connection of the smallbore tubing and the SmartSite Y-port. Class IIFDA’s classApr 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedApr 23, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Idaho, Maryland, Michigan, North Carolina, Nevada, Oklahoma, Oregon, Pennsylvania, Texas, Virginia and Wisconsin named
- Medical device recall AXIOM Vertix MD Trauma systems radiographic X-ray There is a potential issue and possible hazard to patients when using the AXIOM Vertix MD Trauma systems. Class IIFDA’s classApr 23, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 23, 2014ClassClass IIStatusTerminatedWhereMissouri and Ohio
- Medical device recall Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology,… Block assembly-lock stop subframe of service latch was not manufactured to engineering specifications from the supplier, causing premature fracture of the… Class IIFDA’s classApr 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedApr 23, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Indiana, Kentucky, Maryland, South Carolina and Texas named
- Medical device recall The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic x-ray) is designed to provide… GE Healthcare has identified a potential safety issue related to the screws that attach the workstation monitor spring arm to the extension arm on certain OEC… Class IIFDA’s classApr 23, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 23, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures. Obsolete versions of the Laser Treatment Settings card for the Fraxel DUAL 1550/1927 Laser system may have contained incorrect indication for use for treatment… Class IIFDA’s classApr 23, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 23, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc. A customer reported that after upgrading to software version 3.5.5 from 3.5.4, reconstructions would intermittently not complete. Class IIFDA’s classApr 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedApr 23, 2014ClassClass IIStatusTerminatedWhereNationwide, and Michigan, Oregon, Pennsylvania, Texas and West Virginia named
- Medical device recall Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Incorrect customer notification label applied to the Tyvek lid of this specific lot of Terumo¿ Cardiovascular Procedure Kits Class IIFDA’s classApr 23, 2014in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedApr 23, 2014ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, 18 and 20 French,… Potential for separation of dilator tips. Class IIFDA’s classApr 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae with Duraflo Coating, arterial cannula sizes… Potential for separation of dilator tips. Class IIFDA’s classApr 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve… Ensuring all customers have the tools to assist in verifying the setting of the valve on x-ray images and the location and orientation of implanted CODMAN… Class IIFDA’s classApr 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Brainlab, Spine & Trauma 3D 2.0, Navigation Software The “fluoro match registration” function of the Navigation Software Spine & Trauma 3D 2.0 allows the user to intraoperatively match e.g., CT data sets to the… Class IIFDA’s classApr 23, 2014in FDA’s Enforcement Report15 statesnamed in where it went PublishedApr 23, 2014ClassClass IIStatusTerminatedWhereArizona, California, Georgia, Illinois, Indiana, Louisiana, Massachusetts, Michigan, North Carolina, New York, Ohio, Pennsylvania, Tennessee, Texas and Wisconsin
- Medical device recall VITROS Chemistry Products CRBM Slides The firm identified a potential for biased carbamazepine (CRBM) results to be generated when using VITROS CRBM Slides, Lot 3920-0080-8403. Class IIFDA’s classApr 23, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 23, 2014ClassClass IIStatusTerminatedWhereIndiana, Maryland and Tennessee
- Medical device recall 5X300 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curved Cannulae to become damaged during use. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall 5X300 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curved Cannulae to become damaged during use. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall 5X250 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curved Cannulae to become damaged during use. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall 5X250 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curved Cannulae to become damaged during use. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Playtex Nurser Deluxe Double Electric Breast Pump Some of the power adapters outer casings may become loose and separate, resulting in a potential for electric shock. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Syphilis Test Strip (Serum) LumiQuick, Santa Clara, CA 95054 Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
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.”
Your shortlist0 of 4
Add one more to compare.