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 Dimension TSH Flex Reagent Cartridge (REF RF412) A rare variant of TSH, identified in a small cluster of patients, is not detected. Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612) A rare variant of TSH, identified in a small cluster of patients, is not detected. Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dimension Vista System TSH Flex Reagent Cartridge (REF K6412) A rare variant of TSH, identified in a small cluster of patients, is not detected. Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T, L2KTS6 - 600T) A rare variant of TSH, identified in a small cluster of patients, is not detected. Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IMMULITE Systems Rapid TSH (REF LKRT1 - 100T, LKRT5 - 500 T, L2KRT2 - 200T, L2KRT6 - 600T) A rare variant of TSH, identified in a small cluster of patients, is not detected. Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Correction to provide clarification and additional labeling to minimize likelihood on implanting filter backwards. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedAug 14, 2013ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, 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, 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 CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide, and Florida, Iowa, Illinois, Michigan, North Carolina, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Texas, Washington and Wisconsin named
- Medical device recall Discount Drug Mart Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide, and Florida, Iowa, Illinois, Michigan, North Carolina, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Texas, Washington and Wisconsin named
- Medical device recall Duane Reade (DR) Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide, and Florida, Iowa, Illinois, Michigan, North Carolina, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Texas, Washington and Wisconsin named
- Medical device recall HEB Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide, and Florida, Iowa, Illinois, Michigan, North Carolina, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Texas, Washington and Wisconsin named
- Medical device recall Leader Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide, and Florida, Iowa, Illinois, Michigan, North Carolina, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Texas, Washington and Wisconsin named
- Medical device recall Meijer Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide, and Florida, Iowa, Illinois, Michigan, North Carolina, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Texas, Washington and Wisconsin named
- Medical device recall Premier Value Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide, and Florida, Iowa, Illinois, Michigan, North Carolina, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Texas, Washington and Wisconsin named
- Medical device recall TopCare Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide, and Florida, Iowa, Illinois, Michigan, North Carolina, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Texas, Washington and Wisconsin named
- Medical device recall Walgreens (“W” and “Well at Walgreens”) Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide, and Florida, Iowa, Illinois, Michigan, North Carolina, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Texas, Washington and Wisconsin named
- Medical device recall bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Nestle Nutrition, Compat, Enteral Feeding Tube, sterile, 8 French (REF 08310400), 10 French (REF 08310600),… Nestle HealthCare Nutrition, Inc. Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall BD Vacutainer Multiple Sample and Direct Draw Luer Adapter BD Franklin Lakes, NJ 07417 USA A sterile… BD Vacutainer Multiple Sample and Direct Draw Luer Adapter may have blood leakage and low draw volume. Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107) Product Usage: The TACR… Siemens initiated a recall due to confirmed complaints of low patient sample recovery with Dimension TACR Flex Reagent cartridge (DF107) lot BB4087 and its… Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, District of Columbia, Florida, Georgia, Indiana, Louisiana, Maryland, Michigan, Missouri, North Carolina, New Hampshire, New Jersey, New Mexico, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia and Wisconsin named
- Medical device recall Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass Creatine Kinase MB isozyme… Siemens Healthcare Diagnostics has received complaints that the lyophilized cake is not fully dissolved after the stated time in the MMB calibrator… Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Guam, 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, West Virginia and Wyoming named
- Medical device recall Rev E PedFuse Return Screw Inserter Inserters have a set screw that fixes a collar to the inserter. Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportTexasthe one state its words name PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereTexas
- Medical device recall Invue Split Driver, Assembly with Handle Device design. Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide, and Missouri, Ohio and Texas named
- Medical device recall R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and one batch of 62 mm 20o R3 XLPE liner may be laser etched and… Class IIFDA’s classAug 14, 2013in FDA’s Enforcement Report13 statesnamed in where it went PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereFlorida, Iowa, Indiana, Kentucky, Michigan, Missouri, New York, Oregon, Pennsylvania, Tennessee, Texas, Washington and Wisconsin
- Medical device recall R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, QTY One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and one batch of 62 mm 20o R3 XLPE liner may be laser etched and… Class IIFDA’s classAug 14, 2013in FDA’s Enforcement Report13 statesnamed in where it went PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereFlorida, Iowa, Indiana, Kentucky, Michigan, Missouri, New York, Oregon, Pennsylvania, Tennessee, Texas, Washington and Wisconsin
- Medical device recall TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Br¿nsh¿j, Denmark,… RADIOMETER became aware that the TCM4 series Base Unit does not comply with IEC 60601-1 Sub Clause 15B. Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier Software anomaly: Mitsubishi Heavy Industries, Ltd. Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide, and Florida and Texas named
- Medical device recall T-Handle, Strike Plate, Push Connection During an operation the strike plate of a T-Handle loosened and separated from the T-Handle. Class IIFDA’s classAug 14, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereMassachusetts, Nevada and Texas
- Medical device recall Indus Invue Screw Caddy Difficulty removing screws from the Invue caddies. Class IIFDA’s classAug 14, 2013in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereColorado, Connecticut, Florida, Massachusetts, Mississippi, Texas and Virginia
- Medical device recall BD Affirm VPIII Microbial Identification Tests In vitro diagnostic test kit may exhibit invalid internal negative control results. Class IIFDA’s classAug 7, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Potential to electrostatic discharged (ESD) Class IIFDA’s classAug 7, 2013in FDA’s Enforcement Report29 statesnamed in where it went PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Picis ED Pulsecheck - EMR Software Application - 2125, Software Versions: 5.2 and 5.3 Notes associated with prescription are not printed to the prescription or to the patient chart. Class IIFDA’s classAug 7, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Idaho, Indiana, Massachusetts, Maryland, Missouri, New Hampshire, New Jersey, Ohio, Oregon, South Carolina, Tennessee, Washington and West Virginia named
- Medical device recall Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor for the following… The Instruction for Use 1v9 Ref F and all previous versions specify incorrect dimensions for the Ready To Use (RTU) bottles from other suppliers than Leica. Class IIFDA’s classAug 7, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp It was discovered internally that there was a discrepancy between the insert provided with the Tube to Tube Clamp and what was called for in the Bill of… Class IIFDA’s classAug 7, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedAug 7, 2013ClassClass IIStatusOngoingWhereCalifornia, Minnesota, North Carolina and Tennessee
- Medical device recall ViSi Mobile Monitor Sotera Wireless, Inc. Class IIFDA’s classAug 7, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereCalifornia and Utah
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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