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Recalls Medical devices 2019

Medical devices, 2019

Shortlist up to four to read them side by side.

2,801 medical device recalls FDA’s Enforcement Report published in 2019, 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.

2,801of 2,801 medical device recallsshown with your filters

By the year FDA published them20262,589 20252,908 20243,394 20232,477 20222,192 20212,303 20203,05520192,80120183,757 20172,615 20163,246 20152,495 20143,059 20132,249 20121,310

Filters

FDA’s class Class IClass IIClass III

FDA’s own classes: Class I is the most serious. Each recall’s page quotes FDA’s definition.

Status, in FDA’s file OngoingCompletedTerminated

Where it went, in FDA’s words FDA says nationwideAlabamaAlaskaAmerican SamoaArizonaArkansasCaliforniaColoradoConnecticutDelawareDistrict of ColumbiaFloridaGeorgiaGuamHawaiiIdahoIllinoisIndianaIowaKansasKentuckyLouisianaMaineMarylandMassachusettsMichiganMinnesotaMississippiMissouriMontanaNebraskaNevadaNew HampshireNew JerseyNew MexicoNew YorkNorth CarolinaNorth DakotaNorthern Mariana IslandsOhioOklahomaOregonPennsylvaniaPuerto RicoRhode IslandSouth CarolinaSouth DakotaTennesseeTexasUS Virgin IslandsUtahVermontVirginiaWashingtonWest VirginiaWisconsinWyoming

The states FDA’s words on where the product went name. “Nationwide” is its own choice: to FDA it means the fifty states or a significant portion, so a recall is never counted for a state its words don’t name.

The reason Sterility not assuredMay fail, or give wrong resultsChemicals, metals or drugs that shouldn’t be in itGerms: Listeria, Salmonella, E. coli and othersLabels that are wrong or missingStrength, purity or how it was madePieces of metal, glass or plastic

Grouped from FDA’s own reason for each recall, which every record shows in full.

Published in FDA’s report

Any

In FDA’s record Class IStill ongoing

The list

Filter by product, brand, reason or number

Order the list NewestNewest firstNameName

Medical device recallsPublishedClassStatusWhere

Medical device recall DigitalDiagnost C50, Stationary X-ray System During recent evaluations of the Philips DigitalDiagnost C50 system, Philips identified a missing label. Class IIFDA’s classOct 2, 2019in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedOct 2, 2019ClassClass IIStatusTerminatedWherePuerto Rico
Medical device recall QuickGraft¿ Model # 430PST Measurement listed on the label is not taken under tension, and this would cause possible extension of surgical time needed to complete the procedure. Class IIFDA’s classOct 2, 2019in FDA’s Enforcement Report6 statesnamed in where it went PublishedOct 2, 2019ClassClass IIStatusTerminatedWhereLouisiana, Missouri, North Carolina, New York, Ohio and Texas
Medical device recall Philips HeartStart Infant/Child SMART Pads Cartridge The recall is being initiated due to incorrect age range labeling (8+ yrs) on the foil packaging for infant/child pad cartridges. Class IIFDA’s classOct 2, 2019in FDA’s Enforcement Report51 statesnamed in where it went PublishedOct 2, 2019ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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 MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasma using respectively the… Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, catalogue number 8L25-30 and 08P5320 to prevent the potential for… Class IIFDA’s classOct 2, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2019ClassClass IIStatusTerminatedWhereNationwide
Medical device recall Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in serum or plasma using respectively… Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, catalogue number 8L25-30 and 08P5320 to prevent the potential for… Class IIFDA’s classOct 2, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2019ClassClass IIStatusTerminatedWhereNationwide
Medical device recall Gold Cup Leadwire and Snap Leadwire with the following component descriptions: 1. 24” Snap Leadwire, Blue The electrode lead connector has a protruding conductor beyond insulation of approximately 0.1 mm. Class IIFDA’s classOct 2, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedOct 2, 2019ClassClass 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, 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 named
Medical device recall Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following… Customers who utilize PharmGuard¿ Server Software (PGS) with Medfusion¿ 4000 pumps manufactured prior to November 10, 2017, may experience wireless network… Class IIFDA’s classOct 2, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedOct 2, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
Medical device recall 8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Catheters Product Code:… Products may contain the incorrect banner card within the kit Class IIFDA’s classOct 2, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2019ClassClass IIStatusTerminatedWhereNationwide
Medical device recall Arrow 8.5 Fr Products may contain the incorrect banner card within the kit Class IIFDA’s classOct 2, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2019ClassClass IIStatusTerminatedWhereNationwide
Medical device recall Randox Urinalysis Control Level 2 (IVD) Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. Class IIIFDA’s classOct 2, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 2, 2019ClassClass IIIStatusTerminatedWhereNationwide, and Indiana and West Virginia named
Medical device recall V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an… Instrument stopped working due to a software lockup, and no patient results are produced. Class IIFDA’s classOct 2, 2019in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedOct 2, 2019ClassClass IIStatusOngoingWhereNew York
Medical device recall The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour polyester graft… Based on an internal incident report, Getinge/Intervascular SAS has identified that the one (1) HEMASHIELD GOLD Knitted Microvel Double Velour Vascular… Class IIFDA’s classOct 2, 2019in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedOct 2, 2019ClassClass IIStatusTerminatedWhereNew Jersey
Medical device recall Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used… It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation. Class IIFDA’s classOct 2, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 2, 2019ClassClass IIStatusOngoingWhereNationwide, and Iowa, Indiana, New York, Ohio, Texas and Wisconsin named
Medical device recall Monaco RTP System, 5.50/5.51, radiation treatment planning system Product Usage: The Monaco system is used to… It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation. Class IIFDA’s classOct 2, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 2, 2019ClassClass IIStatusOngoingWhereNationwide, and Iowa, Indiana, New York, Ohio, Texas and Wisconsin named
Medical device recall Accu-Chek Connect Diabetes Management App Users with Android OS 8.0 and above may be unable to transfer values obtained on their meter to the App. Class IIFDA’s classOct 2, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2019ClassClass IIStatusTerminatedWhereNationwide
Medical device recall Atellica IM anti-CCP IgG (aCCP) Assay Siemens Material Number: 10732998 Atellica IM anti-CCP IgG (aCCP) Test Definition (TDef) Mitigation Failure-reagent carryover mitigation for the Testosterone II (TSTII) assay is unable to be… Class IIFDA’s classOct 2, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 2, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Kentucky, New Hampshire and Texas named
Medical device recall APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product The firm identified customer sites where modules which the safety pacemaker label is missing. Class IIFDA’s classOct 2, 2019in FDA’s Enforcement Report21 statesnamed in where it went PublishedOct 2, 2019ClassClass IIStatusTerminatedWhereArizona, California, Connecticut, Florida, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Minnesota, North Carolina, North Dakota, New Jersey, Nevada, New York, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Washington
Medical device recall MEDLINE ELECTRIC SURGICAL CLIPPER AND BASE The recall is being conducted due to a potential defective component on the circuit board causing the charger base to overheat which could result in a charger… Class IIFDA’s classOct 2, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2019ClassClass IIStatusOngoingWhereNationwide
Medical device recall Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0 The sets are configured with quick connectors that have been assembled in reverse on the arterial and venous lines, resulting in blue (venous) to red… Class IIFDA’s classSep 25, 2019in FDA’s Enforcement Report17 statesnamed in where it went PublishedSep 25, 2019ClassClass IIStatusTerminatedWhereArkansas, California, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, North Carolina, Nebraska, New Mexico, Nevada, New York, Ohio, Oregon, Tennessee and Wisconsin
Medical device recall Hemospray Endoscopic Hemostat Potential for Hemospray device to be unable to spray powder due to misassembly of devices. Class IIFDA’s classSep 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedSep 25, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Connecticut, Florida, Illinois, Indiana, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Dakota, Texas, Virginia and Washington named
Medical device recall Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL) - earlier than expected due to compromised performance of an… Class IIFDA’s classSep 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedSep 25, 2019ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin and Wyoming named
Medical device recall Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse… Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL) - earlier than expected due to compromised performance of an… Class IIFDA’s classSep 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedSep 25, 2019ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin and Wyoming named
Medical device recall AD-TECH Drill Sleeve Guides, used with Ad-Tech Placement Kits: (a) The inner diameter of the drill sleeve guide raw material was found to be under tolerance, potentially resulting in the drill bit seizing in the guide during… Class IIFDA’s classSep 25, 2019in FDA’s Enforcement Report18 statesnamed in where it went PublishedSep 25, 2019ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Illinois, Massachusetts, Maryland, Michigan, Minnesota, New Hampshire, New York, Ohio, Oregon, Pennsylvania, Texas, Utah, Washington and Wisconsin
Medical device recall LEEP Return Patient Pads Discrepancy between the correct expiration dates on the individual pouches inside the boxes and incorrect expiration dates on the outer boxes, where the month… Class IIIFDA’s classSep 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedSep 25, 2019ClassClass IIIStatusTerminatedWhereNationwide, and Alaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
Medical device recall IntelliVue 1.4 GHz Remote Antenna Used with Philips MX4O Monitors-The affected product is a 74 foot Remote Antenna Cable Used with Philips MX4O Monitors Does Not Have the Required Rating for Some Installations Class IIFDA’s classSep 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2019ClassClass IIStatusTerminatedWhereNationwide
Medical device recall Hudson RCI Sheridan LTS: a) 4.0 mm Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2019ClassClass IStatusTerminatedWhereNationwide
Medical device recall Hudson RCI Sheridan/CF: a) 3.0 mm Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2019ClassClass IStatusTerminatedWhereNationwide
Medical device recall Hudson RCI Sheridan EZ-ENDO: a) 5.0 mm Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2019ClassClass IStatusTerminatedWhereNationwide
Medical device recall Hudson RCI Sheridan Preformed: a) 3.0 mm Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2019ClassClass IStatusTerminatedWhereNationwide
Medical device recall Hudson RCI Sheridan Uncuffed: a) 2.0 mm Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2019ClassClass IStatusTerminatedWhereNationwide
Medical device recall Hudson RCI Sheridan/HVT: a) 5.0 mm Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2019ClassClass IStatusTerminatedWhereNationwide
Medical device recall Sheridan/CF Novaplus 7.0 mm Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2019ClassClass IStatusTerminatedWhereNationwide
Medical device recall Sheridan/HVT Novaplus: a) 7.0 mm Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2019ClassClass IStatusTerminatedWhereNationwide
Medical device recall Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style… The action was initiated following notification by the U.S. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedSep 18, 2019ClassClass IStatusOngoingWhereNationwide, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Washington, Wisconsin, West Virginia and Wyoming named
Medical device recall Natrelle 410, Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant Biocell Low Height Low… The action was initiated following notification by the U.S. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedSep 18, 2019ClassClass IStatusOngoingWhereNationwide, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Washington, Wisconsin, West Virginia and Wyoming named
Medical device recall Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers: Style TRL:… The action was initiated following notification by the U.S. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedSep 18, 2019ClassClass IStatusOngoingWhereNationwide, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Washington, Wisconsin, West Virginia and Wyoming named
Medical device recall Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following… The action was initiated following notification by the U.S. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedSep 18, 2019ClassClass IStatusOngoingWhereNationwide, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Washington, Wisconsin, West Virginia and Wyoming named
Medical device recall Natrelle 133 Tissue Expanders (also named style 133 BIOSPAN Tissue Expander and Mcghan Magna-Site Tissue… The action was initiated following notification by the U.S. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedSep 18, 2019ClassClass IStatusOngoingWhereNationwide, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Washington, Wisconsin, West Virginia and Wyoming named
Medical device recall Natrelle133 Plus Tissue Expander With/Without Suture Tabs, BioCell Full Height Variable Projection with… The action was initiated following notification by the U.S. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedSep 18, 2019ClassClass IStatusOngoingWhereNationwide, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Washington, Wisconsin, West Virginia and Wyoming named
Medical device recall Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Projection with MAGNA-FINDEr Xact &… The action was initiated following notification by the U.S. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedSep 18, 2019ClassClass IStatusOngoingWhereNationwide, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Washington, Wisconsin, West Virginia and Wyoming named
Medical device recall McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intended for temporary subcutaneous… The action was initiated following notification by the U.S. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedSep 18, 2019ClassClass IStatusOngoingWhereNationwide, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Washington, Wisconsin, West Virginia and Wyoming named
Medical device recall McGhan BioDIMENSIONAL silicone-Filled Breast Implants, style 153 Product Usage: Breast augmentation and… The action was initiated following notification by the U.S. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedSep 18, 2019ClassClass IStatusOngoingWhereNationwide, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Washington, Wisconsin, West Virginia and Wyoming named
Medical device recall Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implant, Styles LL, LM, LF, ML, MM, MF, FL, FM,… The action was initiated following notification by the U.S. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedSep 18, 2019ClassClass IStatusOngoingWhereNationwide, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Washington, Wisconsin, West Virginia and Wyoming named
Medical device recall Natrelle 510, TruForm, Dual-Gel, BIOCELL, Styles LX, MX, FX Product Usage: Breast augmentation and Breast… The action was initiated following notification by the U.S. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedSep 18, 2019ClassClass IStatusOngoingWhereNationwide, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Washington, Wisconsin, West Virginia and Wyoming named
Medical device recall Natrelle and McGhan Silicone-Filled Breast Implants, TruForm 2 (Soft Touch), BIOCELL, Styles 110 Soft Touch… The action was initiated following notification by the U.S. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedSep 18, 2019ClassClass IStatusOngoingWhereNationwide, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Washington, Wisconsin, West Virginia and Wyoming named
Medical device recall Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styles KML, KMM, KLL, KLM Product… The action was initiated following notification by the U.S. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedSep 18, 2019ClassClass IStatusOngoingWhereNationwide, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Washington, Wisconsin, West Virginia and Wyoming named
Medical device recall RITZ PRINCESS, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles RML, RMM, RFL, RFM Product Usage:… The action was initiated following notification by the U.S. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedSep 18, 2019ClassClass IStatusOngoingWhereNationwide, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Washington, Wisconsin, West Virginia and Wyoming named
Medical device recall Natrelle 150 Full Height and Short Height Implants, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant,… The action was initiated following notification by the U.S. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedSep 18, 2019ClassClass IStatusOngoingWhereNationwide, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Washington, Wisconsin, West Virginia and Wyoming named

Before these 913 to 960 of 2,801 After these

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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.”

Medical devices, 2019

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How to read a record

Four things every record does, shown on an example record made up for this guide.

An example record, made up for this guide

An example nursing home

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Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

This home 11

State average 14.3

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

From the homeNone yet. Replies and paid listings aren’t open, and when they open they will sit here, below the record.

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