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 The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative… Beckman Coulter Inc. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SOL SYS 8IN CALCAR SZ12 Packaging: Product is An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall SOL SYS F 8 CALC 13.5MM LG Packaging: Product is An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall SOL SYS 8IN CALC 1.5/15.0 Packaging: Product is An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall SOL SYS 8IN CALC 1.5/16.5 Packaging: Product is An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall SOL SYS 8IN CALC 1.5/18.0 Packaging: Product is An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall SOL SYS 8IN CALC 1.5/19.5 Packaging: Product is An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall SOL SYS F 9 CALC L 13.5MM LG Packaging: Product is An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall SOL SYS L 9IN CALC 2.25/15.0 Packaging: Product is An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall SOL SYS L 9IN CALC 2.25/16.5 Packaging: Product is An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall SOL SYS L 9IN CALC 2.25/18 Packaging: Product is An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall SOL SYS L 9IN CALC 2.25/19.5 Packaging: Product is An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall SOL SYS L 9IN CALC 2.25/21 Packaging: Product is An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall SOL SYS L 9IN CALC 2.25/22.5 Packaging: Product is An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall SOL SYS F 9 CALC L 13.5MM LG Packaging: Product is An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall SOL SYS R 9IN CALC 2.25/15.0 Packaging: Product is An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall SOL SYS R 9IN CALC 2.25/16.5 Packaging: Product is An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall SOL SYS R 9IN CALC 2.25/18 Packaging: Product is An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall SOL SYS R 9IN CALC 2.25/19.5 Packaging: Product is An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall SOL SYS R 9IN CALC 2.25/21 Packaging: Product is An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall SOL SYS R 9IN CALC 2.25/22.5 Packaging: Product is An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM) Posterior fluidics modules installed in the system may need to be recalibrated. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Medrad(R) Continuum MR Infusion Pump Peristaltic Pump System designed for patients who require medications… Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153,… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medrad(R) Continuum MR Infusion System Standard Administration Kit Peristaltic Pump System designed for… Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153,… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medrad(R) Continuum MR Infusion System Secondary Administration Kit Peristaltic Pump System designed for… Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153,… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medrad(R) Continuum MR Infusion System Primary Set Peristaltic Pump System designed for patients who require… Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153,… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medrad(R) Continuum MR Infusion System Primary VSA Stopcock Set Peristaltic Pump System designed for patients… Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153,… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medrad(R) Continuum MR Infusion System Primary VSA Set Peristaltic Pump System designed for patients who… Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153,… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medrad(R) Continuum MR Infusion System Primary Spike Set Peristaltic Pump System designed for patients who… Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153,… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medrad(R) Continuum MR Infusion System Secondary Set Peristaltic Pump System designed for patients who… Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153,… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medrad(R) Continuum MR Infusion System Secondary Spike Set Peristaltic Pump System designed for patients who… Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153,… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medrad(R) Continuum MR Infusion System Secondary VSA Set Peristaltic Pump System designed for patients who… Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153,… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medrad(R) Continuum MR Infusion System Side Step Set Peristaltic Pump System designed for patients who… Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153,… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Segmented Cervix Applicator Set The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect from cervical sleeve. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereGeorgia
- Medical device recall The GlideScope Video Laryngoscope (GVL) is a video laryngoscope that incorporates a high-resolution color… Re-usable video laryngoscope blades of the GlideScope GVL3, GVL4, and GVL5 were recalled due to potential cracking. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedDec 19, 2012ClassClass IStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall Plum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that provide wired Ethernet and wireless… The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating… Class IIFDA’s classDec 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 19, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Plum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet Software and a Connectivity Engine… The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating… Class IIFDA’s classDec 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 19, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Plum A+ Single Channel Infusion Pumps with Hospira Mednet Software and a Connectivity Engine peripheral… The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating… Class IIFDA’s classDec 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 19, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS¿… Roche Molecular Systems, Inc. Class IIFDA’s classDec 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler… Roche Molecular Systems, Inc. Class IIFDA’s classDec 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation of… Roche Molecular Systems, Inc. Class IIFDA’s classDec 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quantification… Roche Molecular Systems, Inc. Class IIFDA’s classDec 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection and/or… Roche Molecular Systems, Inc. Class IIFDA’s classDec 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully automated, random-access,… Roche Molecular Systems, Inc. Class IIFDA’s classDec 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry… Roche Molecular Systems, Inc. Class IIFDA’s classDec 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry /… Roche Molecular Systems, Inc. Class IIFDA’s classDec 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DataCara GM is an information management system that provides data management functionality for managing… Roche Molecular Systems, Inc. Class IIFDA’s classDec 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DataCare POC is an information management system that provides data management functionality for managing… Roche Molecular Systems, Inc. Class IIFDA’s classDec 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 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.”
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