Medical devices, 2013
Shortlist up to four to read them side by side.
2,249 medical device recalls FDA’s Enforcement Report published in 2013, 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.
2,249of 2,249 medical device recallsshown with your filters
The list
- Medical device recall Microscan plus Negative Combo 3 Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedSep 18, 2013ClassClass IStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Maryland, Minnesota, Missouri, South Carolina, South Dakota, Texas and Wisconsin named
- Medical device recall Microscan plus Negative Urine Combo 4 Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedSep 18, 2013ClassClass IStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Maryland, Minnesota, Missouri, South Carolina, South Dakota, Texas and Wisconsin named
- Medical device recall Microscan plus Negative Breakpoint Combo 4 Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedSep 18, 2013ClassClass IStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Maryland, Minnesota, Missouri, South Carolina, South Dakota, Texas and Wisconsin named
- Medical device recall MicroscanrapID/S panels NC3.11 Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedSep 18, 2013ClassClass IStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Maryland, Minnesota, Missouri, South Carolina, South Dakota, Texas and Wisconsin named
- Medical device recall Microscan rapID/S panels NC3.12 Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedSep 18, 2013ClassClass IStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Maryland, Minnesota, Missouri, South Carolina, South Dakota, Texas and Wisconsin named
- Medical device recall Microscan rapID/S panels NC3.33 Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedSep 18, 2013ClassClass IStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Maryland, Minnesota, Missouri, South Carolina, South Dakota, Texas and Wisconsin named
- Medical device recall Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer GE Healthcare has recently become aware of a potential safety issue involving the pre-operative check, low pressure leak test at 1% dial setting of the Tec 6… Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Tempa DOT Single-Use Clinical Thermometer Medical Indicators TempaDot products may have been mislabeled. Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Indiana, Nevada, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall Outlook ES pump is intended for use with B B. Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Outlook ES pump is intended for use with B This notice is being provided in follow up to the field correction initiated by B. Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Baxa Vial Adapter, 14mm - Luer Lock, Order No Baxter Healthcare Corporation is voluntarily recalling one lot of Baxa Vial Adapters, 14mm - Luer Lock, due to incorrect expiry date. Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNorth Carolina
- Medical device recall Outlook Safety Infusion System Burette Set Reports were received of an incorrectly assembled Outlook Safety Infusion System Burette Set (Product Code 375038), and the investigation determined that one… Class IIFDA’s classSep 18, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereFlorida, New Jersey, New York and Texas
- Medical device recall Xlumena brand NAVIX Access Device A complaint investigation has found that product fractures can occur at the distal end of the catheter under load. Class IIFDA’s classSep 18, 2013in FDA’s Enforcement Report11 statesnamed in where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Indiana, New York, Pennsylvania, South Carolina and Washington
- Medical device recall OPERON D850 Surgical Table Product Usage: Surgical Table Table was not lowering. Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont and Wisconsin named
- Medical device recall ADVIA Centaur Folate Calibration failures and/or significant negative shifts in quality control (QC) and patient results. Class IIFDA’s classSep 18, 2013in FDA’s Enforcement Report46 statesnamed in where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereAlabama, 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, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall ADVIA Centaur Folate Calibration failures and/or significant negative shifts in quality control (QC) and patient results. Class IIFDA’s classSep 18, 2013in FDA’s Enforcement Report46 statesnamed in where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereAlabama, 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, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall ADVIA Centaur Folate Calibration failures and/or significant negative shifts in quality control (QC) and patient results. Class IIFDA’s classSep 18, 2013in FDA’s Enforcement Report46 statesnamed in where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereAlabama, 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, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall ADVIA Centaur Folate Calibration failures and/or significant negative shifts in quality control (QC) and patient results. Class IIFDA’s classSep 18, 2013in FDA’s Enforcement Report46 statesnamed in where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereAlabama, 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, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080 US highway 202 South… During an internal investigation, a formulation error that occurred was identified during the manufacture of the cobas¿ 4800 HPV Master Mix reagent that was… Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall STERRAD 100NX Cassettes The recall of the STERRAD 100NX Cassettes was initiated because Advanced Sterilization Products (ASP) does not have adequate data to support the effectiveness… Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Outlook ES pump is intended for use with B B. Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Surgical microscope The device is used to improve the visibility of objects through magnification and… The brake in the Z axis and/or brakes in the AB and C axes failed during installation. Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, Colorado, New York and Oregon named
- Medical device recall Surgical microscope The device is used to improve the visibility of objects through magnification and… The brake in the Z axis and/or brakes in the AB and C axes failed during installation. Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, Colorado, New York and Oregon named
- Medical device recall Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill Product ID: 8881570121 Product… Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 3 mL Fill Product ID: 8881570123 Product… Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 5 mL Fill Product ID: 8881570125 Product… Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Product ID:8881580121 Product Usage:… Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881580123 Product Usage:… Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881580125 Product Usage:… Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Product ID: 8881590121 Product Usage:… Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881590123 Product Usage:… Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881590125 Product Usage:… Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall StaXx¿ IB Convex Expandable Implant A component Superior endplate manufactured from a different polymer than specified Class IIFDA’s classSep 18, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereFlorida and Oregon
- Medical device recall “***Flo Trac Sensor The Edwards Lifesciences FloTrac Sensor is being recalled due to a manufacturing non-conformance related to incorrect packaging configuration where the IFU was… Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide, and Michigan and Missouri named
- Medical device recall HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack pouches. Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vision One Laser System Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user. Class IIFDA’s classSep 18, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereIllinois, New Jersey and Pennsylvania
- Medical device recall BD Microtainer Quikheel Lancet 1.0 mm incision Depth 2.5 mm Incision Length The Lancet will not retract after activation thus creating a potential for exposure to a used sharp. Class IIFDA’s classSep 18, 2013in FDA’s Enforcement Report7 statesnamed in where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereConnecticut, Illinois, Kentucky, New York, Pennsylvania, Texas and Virginia
- Medical device recall *** 1) Cat. 4341B Catheters included in Thoracentesis Tray and Safe-T Thoracentesis Tray - Drug Free may occlude, preventing drainage of excessive fluid from the pleural cavity… Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Brand Name: Vector TAS 8mm Screw Ormco Corporation is voluntarily recalling one lot of 8 MM Vector TAS Screws because some screws of this lot were machined undersized at the top of the threads… Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal devices The firm initiated the recall of AOA Mini RPE Screw Assembly, because it may be missing a complete weld joining one side of the arm with the screw body. Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall WASP (Walk Away Specimen Process) The recall of the WASP (Walk Away Specimen Process) instrument was initiated because Copan Italia SpA has upgraded the software concerning the broth… Class IIIFDA’s classSep 11, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 11, 2013ClassClass IIIStatusTerminatedWhereCalifornia and Oregon
- Medical device recall CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to… Class IIFDA’s classSep 11, 2013in FDA’s Enforcement Report33 statesnamed in where it went PublishedSep 11, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, West Virginia and Wyoming
- Medical device recall CONFIDENCE SPINAL CEMENT SYSTEM 11CC PLUS KIT During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to… Class IIFDA’s classSep 11, 2013in FDA’s Enforcement Report33 statesnamed in where it went PublishedSep 11, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, West Virginia and Wyoming
- Medical device recall CONFIDENCE SPINAL CEMENT SYSTEM KIT During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to… Class IIFDA’s classSep 11, 2013in FDA’s Enforcement Report33 statesnamed in where it went PublishedSep 11, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, West Virginia and Wyoming
- Medical device recall ADVIA Chemistry A1c_3 Calibrators Siemens confirmed that the ADVIA¿ Chemistry Systems HbA1c method exhibits a positive bias of up to 12% for patient and CAP survey samples due to over-recovery… Class IIFDA’s classSep 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 11, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall SC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis, osteonecrosis,… The firm became aware of an incident relating to a breach of sterility in the sterility barrier packaging of SC2316, Distal Femoral Augment with Screw. Class IIFDA’s classSep 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedSep 11, 2013ClassClass IIStatusTerminatedWhereNationwide, and Oklahoma, Pennsylvania, Texas and Virginia named
- Medical device recall Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irradiation: The Peripheral Cutting… Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cutting Balloon (Monorail and Over-the-Wire) Microsurgical… Class IIFDA’s classSep 11, 2013in FDA’s Enforcement Report43 statesnamed in where it went PublishedSep 11, 2013ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Boston Scientific, FlextomeTM Cutting BalloonTM, Sterilized using irradiation: 1) 4.00mm x 15mm FlextomeTM… Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cutting Balloon (Monorail and Over-the-Wire) Microsurgical… Class IIFDA’s classSep 11, 2013in FDA’s Enforcement Report43 statesnamed in where it went PublishedSep 11, 2013ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
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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