Medical devices, 2012
Shortlist up to four to read them side by side.
1,310 medical device recalls FDA’s Enforcement Report published in 2012, 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 5, 2026.
1,310of 1,310 medical device recallsshown with your filters
The list
- Medical device recall OSS Reamer Sleeve REF132-472662 KNEE REAMER SLEEVE 13.0 thru 20.0 STAINLESS STEEL The OSS Knee Reamer Sleeves… Biomet has initiated this action following an investigation which identified that the thin shaft reamer may get stuck and not slide into the sleeve. Class IIFDA’s classDec 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cobas 8000 Modular Analyzer Series On cobas c 701 and cobas c 702 modules of the Cobas 8000 series analyzer, a mismatch between the reagent probe positioning and the aspirated reagent volumes… Class IIFDA’s classDec 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Virginia, Washington and Wisconsin named
- Medical device recall Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant) Product Usage: The OSS Knee… The items in this lot are missing the ion implantation feature. Class IIFDA’s classDec 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereNationwide, and Wisconsin named
- Medical device recall Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray… With Digital Diagnost R2.0.2 a mirrored “R in a circle” is burnt into the image (if mirrored) in the lower right corner of the image. Class IIFDA’s classDec 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens Mobilette Mira, intended use as Mobile x-ray system. There is a risk of lost images during examination. Class IIFDA’s classDec 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereNationwide, and Georgia, Iowa, Idaho, Illinois, North Carolina, Nebraska, Ohio, South Dakota, Texas and Wisconsin named
- Medical device recall Medpro Elastomeric Infusion Pump Please be aware that this is not a new recall. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 5, 2012ClassClass IStatusTerminatedWhereNationwide, and Illinois named
- Medical device recall 100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated… Terumo Cardiovascular System (TCVS) has received reports of a situation where users experienced a total loss of functionality for some System 1 units. Class IIFDA’s classDec 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedDec 5, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall 220/240V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated… Terumo Cardiovascular System (TCVS) has received reports of a situation where users experienced a total loss of functionality for some System 1 units. Class IIFDA’s classDec 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedDec 5, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall NexGen CompleteKnee Solution Stemmed Nonaugmentable Tibial component The NexGen¿¿ system is a… Zimmer is initiating a lot specific recall of the NexGen¿ Stemmed Nonaugmentable Tibial Component due to the devices being processed through a manufacturing… Class IIFDA’s classDec 5, 2012in FDA’s Enforcement Report13 statesnamed in where it went PublishedDec 5, 2012ClassClass IIStatusTerminatedWhereArizona, California, Florida, Iowa, Illinois, Indiana, Missouri, Nebraska, New Jersey, New York, Ohio, Pennsylvania and Washington
- Medical device recall IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com Product Event Reports revealed a broken reamer experienced intra-operatively. Class IIFDA’s classDec 5, 2012in FDA’s Enforcement Report22 statesnamed in where it went PublishedDec 5, 2012ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Florida, Georgia, Iowa, Illinois, Indiana, Massachusetts, Maryland, Michigan, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circumstances, cause the internal steel rod of the tip to protrude… Class IIFDA’s classDec 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 5, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circumstances, cause the internal steel rod of the tip to protrude… Class IIFDA’s classDec 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 5, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370) Medtronic is recalling certain Vertex Max Drill Tubes which are used with the StealthStation System due to a defect related to the internal threading for… Class IIFDA’s classDec 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedDec 5, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Louisiana, Massachusetts and Michigan named
- Medical device recall Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem (Orthopedic Implant)… It was reported that the surgeon noticed that the Echo 11mm hip stem had an etching indicating it was 13mm stem. Class IIFDA’s classDec 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 5, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Kansas and Maryland named
- Medical device recall Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI) Parks Medical Electronics, Inc. Class IIFDA’s classDec 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 5, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pentron Clinical Metrex Research The firm initiated the recall due to a labeling error. Class IIFDA’s classDec 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 5, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diamedix Is-anti-Sm Test Kit is an EIA… Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification. Class IIFDA’s classDec 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedDec 5, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Idaho, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island, Tennessee and Texas named
- Medical device recall The brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set Iradimed Corporation is recalling MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001 because a section of the device does not… Class IIFDA’s classDec 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedDec 5, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Kentucky, Massachusetts, Maryland, New Jersey, New York, Pennsylvania and Texas named
- Medical device recall GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo… GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR22Oamx and Optima XR200amx with Digital… Class IIFDA’s classDec 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 5, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo… GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR22Oamx and Optima XR200amx with Digital… Class IIFDA’s classDec 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 5, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GE Healthcare Optima XR 200 amx with Digital Upgrade GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR22Oamx and Optima XR200amx with Digital… Class IIFDA’s classDec 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 5, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Kimberly-Clark Patient Warming System Error 85 alarm on the Model 1000 Control Unit was occasionally triggered inappropriately. Class IIFDA’s classDec 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedDec 5, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Wisconsin and West Virginia named
- Medical device recall GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose radiographic imaging of the human… It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GE Healthcare Optima XR 220amx Mobile general purpose radiographic imaging of the human head and body. It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GE Healthcare Optima 200amx Mobile general purpose radiographic imaging of the human head and body. It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of the human head and body. It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Mindray A3 Anesthesia Delivery System Mindray has identified the potential for a system leak resulting an issue related to the carbon dioxide absorber canister gasket on A3/A5 Anesthesia Delivery… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 28, 2012ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Mindray A5 Anesthesia Delivery System Mindray has identified the potential for a system leak resulting an issue related to the carbon dioxide absorber canister gasket on A3/A5 Anesthesia Delivery… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 28, 2012ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin SURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix Kit with Thrombin have an issue within the packing process where a cut could potentially breach the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IStatusTerminatedWhereNationwide
- Medical device recall ETHICON SURGIFLO HEMOSTATIC MATRIX SURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix Kit with Thrombin have an issue within the packing process where a cut could potentially breach the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Product is Full OSSEOTITE 2 Tapered Certain Implant Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Certain Implant due to a manufacturing condition where the depth… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, Connecticut, Florida, Georgia, Hawaii, Illinois, Kentucky, Louisiana, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee and Virginia named
- Medical device recall Product is Full OSSEOTITE Parallel Walled Certain Implant Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Certain Implant due to a manufacturing condition where the depth… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, Connecticut, Florida, Georgia, Hawaii, Illinois, Kentucky, Louisiana, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee and Virginia named
- Medical device recall bioMerieux BacT/ALERT Control Module The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement Report19 statesnamed in where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Kansas, Louisiana, Maryland, Minnesota, Montana, North Carolina, Nevada, New York, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia and Washington
- Medical device recall bioMerieux BacT/ALERT Combo Module The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement Report19 statesnamed in where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Kansas, Louisiana, Maryland, Minnesota, Montana, North Carolina, Nevada, New York, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia and Washington
- Medical device recall bioMerieux BacT/ALERT 3D 60 The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement Report19 statesnamed in where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Kansas, Louisiana, Maryland, Minnesota, Montana, North Carolina, Nevada, New York, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia and Washington
- Medical device recall bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML01, Clinical instrument software, English, Spanish, Italian The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement Report19 statesnamed in where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Kansas, Louisiana, Maryland, Minnesota, Montana, North Carolina, Nevada, New York, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia and Washington
- Medical device recall bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML 02, Clinical instrument software, English, Spanish,… The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement Report19 statesnamed in where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Kansas, Louisiana, Maryland, Minnesota, Montana, North Carolina, Nevada, New York, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia and Washington
- Medical device recall bioMerieux Kit, Instrument & Update, 3D B.40 BTA3D-ZH01, Clinical instrument software, Chinese The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement Report19 statesnamed in where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Kansas, Louisiana, Maryland, Minnesota, Montana, North Carolina, Nevada, New York, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia and Washington
- Medical device recall bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML03, Clinical instrument software, Danish, Greek, Polish,… The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement Report19 statesnamed in where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Kansas, Louisiana, Maryland, Minnesota, Montana, North Carolina, Nevada, New York, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia and Washington
- Medical device recall bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML04, Clinical instrument software, Czech, Estonian,… The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement Report19 statesnamed in where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Kansas, Louisiana, Maryland, Minnesota, Montana, North Carolina, Nevada, New York, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia and Washington
- Medical device recall bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML05, Clinical instrument software, Lithuanian, Latvian,… The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement Report19 statesnamed in where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Kansas, Louisiana, Maryland, Minnesota, Montana, North Carolina, Nevada, New York, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia and Washington
- Medical device recall bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML06, Clinical instrument software, Japanese, Korean,… The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement Report19 statesnamed in where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Kansas, Louisiana, Maryland, Minnesota, Montana, North Carolina, Nevada, New York, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia and Washington
- Medical device recall bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML01, Clinical instrument software, English, Spanish, Italian The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement Report19 statesnamed in where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Kansas, Louisiana, Maryland, Minnesota, Montana, North Carolina, Nevada, New York, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia and Washington
- Medical device recall bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML02, Clinical instrument software, German, French, Swedish The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement Report19 statesnamed in where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Kansas, Louisiana, Maryland, Minnesota, Montana, North Carolina, Nevada, New York, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia and Washington
- Medical device recall bioMerieux Kit, USB HDW, BTA3D60-B-B.40, Clinical instrument software, USB update and mounting… The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement Report19 statesnamed in where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Kansas, Louisiana, Maryland, Minnesota, Montana, North Carolina, Nevada, New York, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia and Washington
- Medical device recall bioMerieux Kit, USB HDW, BTA3D COMBO-B-B.40, Clinical instrument software, USB update and mounting… The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement Report19 statesnamed in where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Kansas, Louisiana, Maryland, Minnesota, Montana, North Carolina, Nevada, New York, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia and Washington
- Medical device recall bioMerieux Kit, USB HDW, BTA3D CONTROL-B-B.40, Clinical instrument software, USB update and mounting… The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement Report19 statesnamed in where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Kansas, Louisiana, Maryland, Minnesota, Montana, North Carolina, Nevada, New York, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia and Washington
- Medical device recall bioMerieux Kit, USB Instrument & Update, 3D B.40 USB-ML03, Clinical instrument software, Danish, Greek,… The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement Report19 statesnamed in where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Kansas, Louisiana, Maryland, Minnesota, Montana, North Carolina, Nevada, New York, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia and Washington
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Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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