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 Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890) Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in System Check failures due to high System Check LOCI… Class IIIFDA’s classApr 10, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 10, 2013ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall Siemens Dimension(R) EXL(TM) LM STM (Siemens Material Number 106393377) Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in System Check failures due to high System Check LOCI… Class IIIFDA’s classApr 10, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 10, 2013ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall Siemens Dimension(R) EXL(TM) 200 (Siemens Material Number 10636929) Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in System Check failures due to high System Check LOCI… Class IIIFDA’s classApr 10, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 10, 2013ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61) The Phosphorus (PHOS) method used on… Siemens Healthcare Diagnostics has initiated a voluntary field action for Dimension(R) PHOS Flex(R) Reagent due to reagent interaction causing falsely… Class IIFDA’s classApr 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedApr 10, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management System consists of the IM2 Data… Horiba Medical is recalling ABX Micros IM2 Data Management System because it may display incorrect patient test results under unanticipated operating… Class IIIFDA’s classApr 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Procedure, a thin, low-voltage electrified… LEEP RediKit Products (for use in Loop Electrosurgical Excision Procedures) have Xylocaine (Lidocaine) HCL (2%) listed on the tray lid label but this is not… 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 LeMaitre Stent Guide: 1102-00 Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised. Class IIFDA’s classApr 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Glow ‘N Tell 20 cm Tape: 1100-00 Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised. Class IIFDA’s classApr 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Vacutainer C&S Transfer Straw Kit C&S Preservative Plus Urine Tube. 4.0 ml, 13 X 75 mm STERILE The BD Vacutainer Urinalysis Transfer Straw Kit #364991, Lot 1335484 has preprinted polybags which are incorrectly labeled as Catalog #364953. Class IIIFDA’s classApr 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedApr 10, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographic Balloon Catheter The product specifications sheet, part of the Instructions for Use (IFU), for the specified product numbers, reference Renografin-76 contrast medium (viscosity… Class IIFDA’s classApr 10, 2013in FDA’s Enforcement Report50 statesnamed in where it went PublishedApr 10, 2013ClassClass IIStatusTerminatedWhereAlaska, 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, 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
- Medical device recall Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid, qualitative… The test strips in the affected product lots of the OC Light immunological fecal occult blood test are being recalled because they may not be stable through… 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 Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. For the rapid, qualitative… The test strips in the affected product lots of the OC Light immunological fecal occult blood test are being recalled because they may not be stable through… 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 Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit The firm was notified by a customer that there was a burr on the inside end of the drill bit resulting in the drill bit not fitting over the associated guide… Class IIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Illinois, Maryland, Michigan, North Carolina, New Mexico, Ohio, Oklahoma, Pennsylvania, South Dakota, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall BD MAX PCR Cartridges Cartridges are not sealing properly during PCR testing and may cause false results, indeterminates and/or invalid runs. Class IIFDA’s classApr 3, 2013in FDA’s Enforcement Report11 statesnamed in where it went PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Indiana, Kansas, New York, Ohio, Oregon, Pennsylvania, Texas and Wisconsin
- Medical device recall BS-200 Chemistry Analyzer Designed for clinical laboratory use. An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate. Class IIFDA’s classApr 3, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereNorth Carolina and Texas
- Medical device recall Needle Counters Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. Class IIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Needle Counters with Blade Disarmer Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. Class IIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Needle Counters with Blade Disarmer Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. Class IIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Needle Counters Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. Class IIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Needle Counters with Blade Disarmer Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. Class IIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Needle Counters Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. Class IIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Needle Counters Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. Class IIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Needle Counters with Blade Disarmer Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. Class IIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Needle Counters with Blade Disarmer Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. Class IIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Qualitative Confirmatory Assay, List… Abbott has identified that assay files for the ARCHITECT HBsAg Qualitative and HBsAg Qualitative Confirmatory assays (LNs 4P53 and 4P54) on the ARCHITECT… Class IIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Hawaii, Louisiana, Massachusetts, Maryland, Missouri, New Jersey, New York, Pennsylvania, Rhode Island, Tennessee, Texas, Utah and Washington named
- Medical device recall Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitro diagnostic… Correlation slope bias and accuracy shift Class IIIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedApr 3, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington and West Virginia named
- Medical device recall VITEK 2 60 computer system when equipped with the following Hewlett-Packard PC models There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS. Class IIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITEK 2 XL computer system when equipped with the following Hewlett-Packard PC models There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS. Class IIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITEK 2 Compact computer system when equipped with the following Hewlett-Packard PC models There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS. Class IIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 in conjunction with specific… In the course of the firm’s product monitoring activities, a potential risk for patient or operators was determined during the operation of an Artis zeego… Class IIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Louisiana, Maryland, Michigan, Missouri, North Carolina, New Hampshire, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Toshiba Infinix-i X-Ray System Lost and incorrect images. Class IIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall KIMGUARD Container Filters, 7.5in Some individual container filter units might contain thin areas that may potentially compromise the ability of the filter to maintain a sterile barrier. Class IIFDA’s classApr 3, 2013in FDA’s Enforcement Report36 statesnamed in where it went PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in critical care areas for… An issue with the plunger rod seal was identified where the seal had the potential to migrate inside the pump case top during slow rate/ high back pressure… Class IIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNew Hampshirethe one state its words name PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereNew Hampshire
- Medical device recall Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed The firm has become aware of a potential issue on Artis systems with the software Artis VC20x/VC21A/VD10x that have a DSA license installed. Class IIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, South Carolina, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall STERRAD 200 System Carriage, P/N 10208 Advanced Sterilization Products (ASP) is recalling the STERRAD 200 System Carriage because it can potentially become dislodged when an excessive load is… Class IIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sepp, Compound Benzoin Tincture An internal review of CareFusion’s labeling for preoperative skin prep product codes was recently conducted. Class IIIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version… Vital Images has found a potential error in measurement generated through the software which affects all versions of Vitrea Enterprise Suite, Vitrea,… Class IIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Cooper Surgical Incontinence Ring Flexible Pessary #4, 2 3/4”, 70mm Pessary mislabeled outer package may not reflect the size of the product contained in the package Class IIIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Cooper Surgical Incontinence Dish w/ Support Pessary #5, 80mm Pessary mislabeled outer package may not reflect the size of the product contained in the package Class IIIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Cooper Surgical Incontinence Dish w/ Support Pessary #0, 55mm Pessary mislabeled outer package may not reflect the size of the product contained in the package Class IIIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm Pessary mislabeled outer package may not reflect the size of the product contained in the package Class IIIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm Pessary mislabeled outer package may not reflect the size of the product contained in the package Class IIIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Cooper Surgical Gellhorn Flexible Pessary -2 3/4”, 70mm Pessary mislabeled outer package may not reflect the size of the product contained in the package Class IIIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Cooper Surgical Gellhorn Flexible Pessary 3”, 76mm Pessary mislabeled outer package may not reflect the size of the product contained in the package Class IIIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Cooper Surgical Cube Pessary 1 5/8””, 41mm Pessary mislabeled outer package may not reflect the size of the product contained in the package Class IIIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Cooper Surgical Cube Pessary w/Drainage Holes #0”1”, 25mm Pessary mislabeled outer package may not reflect the size of the product contained in the package Class IIIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements. Class IIFDA’s classApr 3, 2013in FDA’s Enforcement ReportHawaiithe one state its words name PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereHawaii
- Medical device recall Pyxis Anesthesia System The recall was initiated because Carefusion has confirmed that when the PAS 2000 drawers due to inaccessability of drawers caused by system down time or… Class IIFDA’s classApr 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2013ClassClass IIStatusTerminatedWhereNationwide
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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