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 Dade(R) Actin(R) FSL Activated PTT Reagent Siemens has observed that the listed lot numbers show an increase in Heparin sensitivity over the shelf life which is demonstrated by testing with Dade(R)… Class IIFDA’s classApr 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedApr 17, 2013ClassClass IIStatusTerminatedWhereNationwide, and 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 and West Virginia named
- Medical device recall G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole… The Beta-thalessemia Mode of the G7 Analyzer-Beta Thalassemia Mode is an automated High Performance Liquid Chromatography (HPLC) system that separates and… Class IIIFDA’s classApr 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedApr 17, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Kerr Maxcem Elite, self-etch/self-adhesive resin cement Kerr Corporation is initiating this recall because raw material used to produce the Maxcem Elite is causing the material to prematurely polymerize in the… Class IIFDA’s classApr 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 17, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of the SIEMENS branded ARTISTE and… A potential safety risk with the MOSAIQ Oncology Information System that has been identified by the manufacturer IMPAC Medical Systems, Inc. Class IIFDA’s classApr 17, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 17, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dual-Head Variable… Accelerated fatigue of the lateral axis motion subsystem of the Infinia Computed Emission Tomography System could result in mechanical failure causing the… Class IIFDA’s classApr 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 17, 2013ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall CO2 Incubators (General Purpose Incubator) Incubators manufactured prior to mid 2009 have coated metal hinges that have reportedly failed in the field. Class IIFDA’s classApr 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedApr 17, 2013ClassClass IIStatusTerminatedWhereNationwide, and 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, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Siemens brand ACUSON SC2000 Ultrasound System When using the V5M transducer, the display of the temperature on the ACUSON SC2000 system can be lower than the actual temperature of the V5M transducer. Class IIFDA’s classApr 17, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 17, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators LIFEPAK CR Plus or LIFEPAK Express Automated External Defibrillators (AEDs) are recalled due to the potential to experience an early internal battery depletion… Class IIFDA’s classApr 17, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 17, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall VMX, VMX Plus Mobile Radiographic Unit with the following models: 45296139 GE Healthcare has become aware of an issue associated with the base casting for the articulated arm of your VMX and VMX Plus Mobile X-ray systems that may… Class IIFDA’s classApr 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedApr 17, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Georgia, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Minnesota, Montana, New York, Ohio, Pennsylvania, Texas and Virginia named
- Medical device recall Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracket Buccal Tubes are intended to hold… Ormco Corporation is voluntarily recalling one (1) lot of Bracket Buccal Tubes as a result of a packaging error. Class IIFDA’s classApr 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 17, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic MiniMed Paradigm Insulin Infusion Pumps Medtronic is recalling the Medtronic Paradigm Insulin Pump because the pump’s drive support cap may become detached from the pump case and protrude from the… Class IIFDA’s classApr 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 17, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LHB, Type I First Aid Kit Perishable, Non-Aspirin 4/pg, Aspirin 4/pg and Povidone Iodine, antiseptic towelette The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm’s distributor. Class IIIFDA’s classApr 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedApr 17, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wyoming named
- Medical device recall LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm’s distributor. Class IIIFDA’s classApr 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedApr 17, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wyoming named
- Medical device recall LHB, First Aid Type I Individual Kit, NSN: 6545-00-656-1092, antiseptics, Kit number: 2114002 The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm’s distributor. Class IIIFDA’s classApr 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedApr 17, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wyoming named
- Medical device recall LHB, Perishable Items Pack Type I , Kit Number: 2114002-100 The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm’s distributor. Class IIIFDA’s classApr 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedApr 17, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wyoming named
- Medical device recall LHB, First Aid Type III, NSN # 6545-00-656-1094, Kit number: 2114011 The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm’s distributor. Class IIIFDA’s classApr 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedApr 17, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wyoming named
- Medical device recall LHB, Perishable Item Pack Type III The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm’s distributor. Class IIIFDA’s classApr 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedApr 17, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wyoming named
- Medical device recall LHB, First Aid Type IV Belt Type, NSN #6545-01-010-7754 The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm’s distributor. Class IIIFDA’s classApr 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedApr 17, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wyoming named
- Medical device recall LHB, Perishable Items Pack Type IV The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm’s distributor. Class IIIFDA’s classApr 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedApr 17, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wyoming named
- Medical device recall GE Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ S7 (with software revisions… GE Healthcare has become aware of a potential safety issue due to the S4-10-D Ultrasound Probe used in conjunction with the LOGIQ S8 and LOGIQ S7 Ultrasound… Class IIFDA’s classApr 17, 2013in FDA’s Enforcement Report40 statesnamed in where it went PublishedApr 17, 2013ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fusion or… Siemens has become aware of a potential malfunction and possible hazard to patients and staff when using the Iconos R200 C20, Iconos R200 T20, Iconos R100,… Class IIFDA’s classApr 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedApr 17, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Iowa, Indiana, Kansas, Louisiana, Maine, Michigan, Missouri, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Washington named
- Medical device recall Torrent” irrigation tubing The firm was notified by their customers that there was a water leakage from the white tubing connector. Class IIFDA’s classApr 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedApr 17, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall GE Healthcare, Discovery MR750w 3.0T System GE Healthcare has recently become aware of a potential issue due to image flip in frequency encoding direction associated with a specific workflow of your… Class IIFDA’s classApr 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedApr 17, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Illinois, Maryland, New Jersey, New York, Ohio, Oklahoma and Texas named
- Medical device recall MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System Product Usage: MRI System. It was found that there is a problem with the LCD monitor used in the console. Class IIFDA’s classApr 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedApr 17, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Idaho, Illinois, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania and Puerto Rico named
- Medical device recall Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous… Animas has identified a component issue affecting a small supply of the Animas(R) 2020 insulin pumps. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedApr 10, 2013ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, 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, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Smiths Medical, BCI¿ Remote Alarm Cable (Normally Open & Normally Closed), Reorder Numbers: WW3398NO &… In rare instances, the BCI¿ Remote Alarm Cables (BCI¿ Cable) are not transferring alarms when used with some remote nurse alarm systems. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedApr 10, 2013ClassClass IStatusTerminatedWhereNationwide, and Colorado, Illinois, Indiana, Massachusetts, South Carolina and Wisconsin named
- Medical device recall Z-800 Volumetric Infusion System Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer software to monitor accumulative fluid volume infused by the pump Class IIFDA’s classApr 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark paper and plastic items around… Dual Tip Marker has inconsistent ink flow on the black permanent ink side. Class IIIFDA’s classApr 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a… The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems may emit an… Class IIFDA’s classApr 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization System is a general… The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems may emit an… Class IIFDA’s classApr 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir Certain lots of Reagent reservoirs, may not have a separation in the lower part of the reservoir. Class IIFDA’s classApr 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedApr 10, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Kansas, Kentucky, Louisiana, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall Ingenuity TF PET/CT Issues have been detected in the Ingenuity TF PET/CT currently running software version 4.0.60605.0 that if they were to re-occur, could cause a risk for… Class IIFDA’s classApr 10, 2013in FDA’s Enforcement ReportOhiothe one state its words name PublishedApr 10, 2013ClassClass IIStatusTerminatedWhereOhio
- Medical device recall Integra Ojemann Cortical Stimulator If the headphone jack is in use during a surgical procedure with the OCS2 and a non-intended voltage (such as static electricity) comes in contact with the… Class IIFDA’s classApr 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic Prostiva RF Therapy Generator Medtronic has found through device testing that if the optional footswitch is not connected to the Model 8930 RF generator during use, an electrostatic… Class IIFDA’s classApr 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 10, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Access Immunoassay System Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt pulley that may rub against the light shield, which causes the… Class IIFDA’s classApr 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Access 2 Immunoassay System Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt pulley that may rub against the light shield, which causes the… Class IIFDA’s classApr 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Synchron LXi 725 Clinical System Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt pulley that may rub against the light shield, which causes the… Class IIFDA’s classApr 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall UniCel DxC 600i Synchron Access Clinical System Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt pulley that may rub against the light shield, which causes the… Class IIFDA’s classApr 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B Siemen’s issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. Class IIFDA’s classApr 10, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 10, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B Siemen’s issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. Class IIFDA’s classApr 10, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 10, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B Siemen’s issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. Class IIFDA’s classApr 10, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 10, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B Siemen’s issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. Class IIFDA’s classApr 10, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 10, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B Siemen’s issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. Class IIFDA’s classApr 10, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 10, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B Siemen’s issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. Class IIFDA’s classApr 10, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 10, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B Siemen’s issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. Class IIFDA’s classApr 10, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 10, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B Siemen’s issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. Class IIFDA’s classApr 10, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 10, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B Siemen’s issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. Class IIFDA’s classApr 10, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 10, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Zimmer NexPosure, retractor portals of the NexPosure MIS Access System Possibility that the inner pouch may be compromised. Class IIFDA’s classApr 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedApr 10, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Colorado, Delaware, Florida, Idaho, Michigan, New Hampshire, New Jersey, New Mexico, Pennsylvania, Rhode Island, Texas and Virginia named
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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