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 Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX The intended use of… Internal audio cable may have diminished retention force due to damaged contacts, which could lead to intermittent or loss of audible alarms. Class IIFDA’s classDec 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18 Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance of the SynchroMed infusion pump system. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2012ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Medtronic SynchroMed II Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance of the SynchroMed infusion pump system. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2012ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the… Class IIFDA’s classDec 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedDec 19, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Massachusetts, Minnesota and South Dakota named
- Medical device recall Reusable, Self-Adhering TENS/NMES/FES electrodes Single Patient Use Only Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the… Class IIFDA’s classDec 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedDec 19, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Massachusetts, Minnesota and South Dakota named
- Medical device recall Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes, A cutaneous electrode is an… Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the… Class IIFDA’s classDec 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedDec 19, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Massachusetts, Minnesota and South Dakota named
- Medical device recall Empi STIMC RE Self Adhesive electrodes Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the… Class IIFDA’s classDec 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedDec 19, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Massachusetts, Minnesota and South Dakota named
- Medical device recall WANG Transbronchial Aspiration Needles ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration Needles would not insert properly through the instrument… Class IIFDA’s classDec 19, 2012in FDA’s Enforcement Report14 statesnamed in where it went PublishedDec 19, 2012ClassClass IIStatusTerminatedWhereCalifornia, Florida, Iowa, Indiana, Massachusetts, Maryland, Maine, Missouri, Mississippi, North Carolina, New Mexico, Ohio, Pennsylvania and Texas
- Medical device recall WANG Transbronchial Aspiration Needles ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration Needles would not insert properly through the instrument… Class IIFDA’s classDec 19, 2012in FDA’s Enforcement Report14 statesnamed in where it went PublishedDec 19, 2012ClassClass IIStatusTerminatedWhereCalifornia, Florida, Iowa, Indiana, Massachusetts, Maryland, Maine, Missouri, Mississippi, North Carolina, New Mexico, Ohio, Pennsylvania and Texas
- Medical device recall WANG Transbronchial Aspiration Needles ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration Needles would not insert properly through the instrument… Class IIFDA’s classDec 19, 2012in FDA’s Enforcement Report14 statesnamed in where it went PublishedDec 19, 2012ClassClass IIStatusTerminatedWhereCalifornia, Florida, Iowa, Indiana, Massachusetts, Maryland, Maine, Missouri, Mississippi, North Carolina, New Mexico, Ohio, Pennsylvania and Texas
- Medical device recall WANG Transbronchial Aspiration Needles ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration Needles would not insert properly through the instrument… Class IIFDA’s classDec 19, 2012in FDA’s Enforcement Report14 statesnamed in where it went PublishedDec 19, 2012ClassClass IIStatusTerminatedWhereCalifornia, Florida, Iowa, Indiana, Massachusetts, Maryland, Maine, Missouri, Mississippi, North Carolina, New Mexico, Ohio, Pennsylvania and Texas
- Medical device recall Siemens Healthcare BNP Operating range of the ADVIA Centaur systems is 18¿C to 30¿C (64.4¿F to 86.0¿F), a change in room temperature may increase or decrease assay results, depending… Class IIFDA’s classDec 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens Healthcare BR Assay for CA 27.29 250 Test Kits 03896216 50 Test Kit 02419937 Operating range of the ADVIA Centaur systems is 18¿C to 30¿C (64.4¿F to 86.0¿F), a change in room temperature may increase or decrease assay results, depending… Class IIFDA’s classDec 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens Healthcare ADVIA Centaur CA 19-9 250 Test 10491244 50 Test 10491379 Intended Use The ADVIA Centaur CA… Operating range of the ADVIA Centaur systems is 18C to 30¿C (64.4¿F to 86.0¿F), a change in room temperature may increase or decrease assay results, depending… Class IIFDA’s classDec 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens Healthcare ADVIA Centaur DHEA-504 (DHEAS) 50 Test 06489701 The ADVIA Centaur DHEAS assay is an in… Operating range of the ADVIA Centaur systems is 18C to 30¿C (64.4¿F to 86.0¿F), a change in room temperature may increase or decrease assay results, depending… Class IIFDA’s classDec 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens Healthcare ADVIA Centaur Digitoxin (DGTN) 250 Test 09046419 50 Test 08861968 Intended Use For in… Operating range of the ADVIA Centaur systems is 18¿C to 30¿C (64.4¿F to 86.0¿F), a change in room temperature may increase or decrease assay results, depending… Class IIFDA’s classDec 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens Healthcare ADVIA Centaur Folate (FOL) 500 Test 06891541 100 Test 06367974 Operating range of the ADVIA Centaur systems is 18C¿ to 30¿C (64.4¿F to 86.0¿F), a change in room temperature may increase or decrease assay results, depending… Class IIFDA’s classDec 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens Healthcare ADVIA Centaur Theophylline 2 (THE02) 250 Test 08838753 50 Test 03009619 Intended Use For… Operating range of the ADVIA Centaur systems is 18¿C to 30¿C (64.4¿F to 86.0¿F), a change in room temperature may increase or decrease assay results, depending… Class IIFDA’s classDec 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DPM 6/7 Patient Monitor There is an issue with the DPM 6 and DPM 7 monitors where the following features may be unavailable : Full Disclosure, Drug, Hemodynamic Calculations, Renal… Class IIFDA’s classDec 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedDec 19, 2012ClassClass IIStatusTerminatedWhereNationwide, and Florida, Iowa, Illinois, Louisiana, Michigan, Minnesota, Nebraska, Nevada, Pennsylvania, South Carolina, Tennessee, Texas and Washington named
- Medical device recall MAVIG PORTEGRA 2 system operated in conjuction with a Siemens AX system Ceiling mounted surgical light A particular component may not have been fitted during the installation of some MAVIG PORTEGRA 2 systems. Class IIFDA’s classDec 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Baby Quasar (LAB-001-D, BQ101) and Baby Quasar Pink (LAB-046-A BQ101-P) are infrared LED lamps that are… Quasar Bio-Tech is recalling their Baby Quasar, Baby Quasar Pink, Quasar Power Pack, and Quasar MD because the device is unapproved. Class IIFDA’s classDec 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedDec 19, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Kansas, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oregon, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall Quasar MD is an infrared LED lamp that is labeled in part: “***QUASAR MD***Bringing the Spa Home***Radiant… Quasar Bio-Tech is recalling their Baby Quasar, Baby Quasar Pink, Quasar Power Pack, and Quasar MD because the device is unapproved. Class IIFDA’s classDec 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedDec 19, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Kansas, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oregon, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall Quasar Power Pack contains a Baby Quasar and a Baby Blue Quasar Bio-Tech is recalling their Baby Quasar, Baby Quasar Pink, Quasar Power Pack, and Quasar MD because the device is unapproved. Class IIFDA’s classDec 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedDec 19, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Kansas, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oregon, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324 Advanced Sterilization Products (ASP) is recalling all lots of Sterrad Cyclesure 24 Biological Indicator (BI) manufactured between February 2008 and December… Class IIFDA’s classDec 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase Staining Reagent RTU-TdT-339 is not stable up to the expiry date on the product labeling, affecting the staining intensity. Class IIFDA’s classDec 19, 2012in FDA’s Enforcement Report14 statesnamed in where it went PublishedDec 19, 2012ClassClass IIStatusTerminatedWhereArkansas, California, Florida, Illinois, Maryland, Michigan, Minnesota, Missouri, North Carolina, Oregon, Rhode Island, Tennessee, Texas and Wisconsin
- Medical device recall Cobas b 123 POC system cobas b 123 POC system is fully automated POC system for whole blood in vitro… It has been determined that cobas b 123 Fluid Pack COOX cuvettes for lot numbers 21426121 and 21426171, exhibit a significant increase in the out-of-box… Class IIFDA’s classDec 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 19, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arizona and Nebraska named
- Medical device recall BD BBL Taxo XV Factor Strips In vitro diagnostic test kit was not manufactured according to specifications and may cause false negatives or misidentification of Hemophilus species present… Class IIFDA’s classDec 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The product has the Catalogue/Part number 60010 The Olympic Cool-Cap’s Control Module has experienced a frozen screen during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedDec 12, 2012ClassClass IStatusTerminatedWhereNationwide, and Alaska, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah and Washington named
- Medical device recall Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085) The IRON method is an in vitro diagnostic test for… Siemens Healthcare Diagnostics has confirmed the potential for falsely elevated results with IRON Flex(R) reagent cartridges when tests are processed from a… Class IIFDA’s classDec 12, 2012in FDA’s Enforcement Report46 statesnamed in where it went PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use Failure of glue joint, allowed a portion of the single use device to shift inside, may separate and fall into the patient Class IIFDA’s classDec 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Florida, Massachusetts, New York, Ohio and Oregon named
- Medical device recall Neptune¿ 2 Rover - ULTRA ~120V ~ 60 Hz 12A Beginning May 24, 2011 Stryker Neptune 2 (N2) Waste Management Systems castors were replaced with a new castor design because investigation found the old… Class IIFDA’s classDec 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Neptune¿ 2 Rover - ULTRA ~230V ~ 50 Hz 12A Beginning May 24, 2011 Stryker Neptune 2 (N2) Waste Management Systems castors were replaced with a new castor design because investigation found the old… Class IIFDA’s classDec 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 24 Fr 8mm Sft Flow Str Wire W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending… The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. Class IIFDA’s classDec 12, 2012in FDA’s Enforcement Report28 statesnamed in where it went PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall 24 Fr 8mm Sft Flow Straight Wir The Sarns Aortic Cannula is indicated for use in perfusion of the ascending… The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. Class IIFDA’s classDec 12, 2012in FDA’s Enforcement Report28 statesnamed in where it went PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall 24 Fr 8mm Sft Flow Straight The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta… The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. Class IIFDA’s classDec 12, 2012in FDA’s Enforcement Report28 statesnamed in where it went PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall 18 Fr 6mm Sft Flow Angled Wire The Sarns Aortic Cannula is indicated for use in perfusion of the ascending… The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. Class IIFDA’s classDec 12, 2012in FDA’s Enforcement Report28 statesnamed in where it went PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall 18 Fr 6mm Sft Flow Ang Wire W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending… The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. Class IIFDA’s classDec 12, 2012in FDA’s Enforcement Report28 statesnamed in where it went PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall 24 Fr 8mm Soft Flow Ang Wire W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending… The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. Class IIFDA’s classDec 12, 2012in FDA’s Enforcement Report28 statesnamed in where it went PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall 24 Fr 8mm Soft Flow Ang W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta… The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. Class IIFDA’s classDec 12, 2012in FDA’s Enforcement Report28 statesnamed in where it went PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of… Spectrolyse PAI-1 activity assay, producing lower than expected absorbance values 0 IU/ml standard reducing the slope of the standard curve requiring more… Class IIFDA’s classDec 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereNationwide, and Florida, Indiana, North Carolina, Ohio, Utah and Washington named
- Medical device recall Custom Procedural Trays: Merit’s Custom Total Hip Pack, K12T-05537, Merit’s Total Knee Pack, K12T05538 A… Custom Procedural trays contain Stryker Hytrel Togas which are being recalled because the clear tape that is intended to aid in the prevention of patient’s… Class IIFDA’s classDec 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereNationwide, and Nebraska and South Dakota named
- Medical device recall Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Processing System Firm has become aware of an unintended behavior when using syngo.plaza and issued an Update Instruction. Class IIFDA’s classDec 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Massachusetts, Minnesota, Missouri, New Jersey, New York, Ohio and Wisconsin named
- Medical device recall NeuViz 16 Multi-Sliced CT Scanner System The four screws that secure the patient table top to the carrier pulled out and caused the table top to detach. Class IIFDA’s classDec 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereNationwide, and North Carolina, Ohio, Puerto Rico and Texas named
- Medical device recall BiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium Battery Charger Battery may over-heat during charging and smoke Class IIFDA’s classDec 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereNationwide, and North Carolina, New York and Ohio named
- Medical device recall Invivo Corporation Expression MRI Patient Monitoring System Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling the Expression MRI Patient Monitoring System because during transport of… Class IIFDA’s classDec 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, 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, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Stryker Orthopaedics FEMORAL OFFSET BUSHING TRITHION REVISION INSTRUMENTS Offset Bushings associated with the lots identified were mismarked: the rotational reference numbers on the Tibial Offset Bushing were marked counterclockwise… Class IIFDA’s classDec 12, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Stryker Orthopaedics TIBIAL OFFSET BUSHING TRIATHLON REVISION INSTRUMENTS Offset Bushings associated with the lots identified were mismarked: the rotational reference numbers on the Tibial Offset Bushing were marked counterclockwise… Class IIFDA’s classDec 12, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall OSS Reamer Sleeve REF132-472661 KNEE REAMER SLEEVE 8.0 THRU 12.5 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
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.”
Your shortlist0 of 4
Add one more to compare.