Medical devices, 2016
Shortlist up to four to read them side by side.
3,246 medical device recalls FDA’s Enforcement Report published in 2016, 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 7, 2026.
3,246of 3,246 medical device recallsshown with your filters
The list
- Medical device recall Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce… Siemens is initiating this recall due to a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM… Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Washington named
- Medical device recall Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce… Siemens is initiating this recall due to a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM… Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Washington named
- Medical device recall Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce… Siemens is initiating this recall due to a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM… Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Washington named
- Medical device recall Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce… Siemens is initiating this recall due to a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM… Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Washington named
- Medical device recall Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce… Siemens is initiating this recall due to a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM… Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Washington named
- Medical device recall Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce… Siemens is initiating this recall due to a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM… Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Washington named
- Medical device recall Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce… Siemens is initiating this recall due to a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM… Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Washington named
- Medical device recall VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Accelerator MHI-TM2000 Linear… In rare cases the VERO/MHI-TM2000 Operator Console could set an incorrect Gantry angle for the first beam of an IMRT treatment if certain specific conditions… Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Florida, New York, Ohio and Texas named
- Medical device recall MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the… When editing the isocenter or the couch position of the plan while in the treatment workflow (in the Points screen) and re-optimizing, the software will not… Class IIFDA’s classApr 6, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereCalifornia, Florida, Missouri and Wisconsin
- Medical device recall AXIOM Artis (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional… Possible leak in the cooling system, fluids could potentially seep into the equipment cabinet. Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedApr 6, 2016ClassClass 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, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Artis zee/zeego (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional… Possible leak in the cooling system, fluids could potentially seep into the equipment cabinet. Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedApr 6, 2016ClassClass 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, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Synthes Interlocking Bolt, 151 mm (General and Plastics Surgery Devices) Guide, Surgical Instrument DePuy Synthes is initiating a voluntary medical device recall of certain lots of the Interlocking Bolt which are a part of the Synthes 4.5 mm LCP Proximal… Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000¿ is intended for use with the… When a user performed radiography using the wireless FPD, a message window appeared on the monitor stating that imaging transmission was not completed with no… Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide, and Florida, Louisiana, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah, Wisconsin and West Virginia named
- Medical device recall Universal Clamp¿ System (IFU reference: SNA027-N-90001) Zimmer Biomet is initiating a Medical Device Correction Notice to provide updated cleaning and disinfecting instructions for use of the Instinct¿ Java¿ System… Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Instinct¿ Java¿ System (IFU reference: 046WAN0000T) Zimmer Biomet is initiating a Medical Device Correction Notice to provide updated cleaning and disinfecting instructions for use of the Instinct¿ Java¿ System… Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touchpad Recalled by FDA on Mar 30, 2016 Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Algostim LLC, Algovita Implanted Pulse Generator stimulator The implantable pulse generator (IPG) model 2408 had suboptimal performance establishing a connection to the external devices unless they were brought into… Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Algostim LLC, Algovita Implanted Pulse Generator stimulator The implantable pulse generator (IPG) model 2408 had suboptimal performance establishing a connection to the external devices unless they were brought into… Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Algostim LLC, Algovita External Pulse Generator, Trial Stimulator The implantable pulse generator (IPG) model 2408 had suboptimal performance establishing a connection to the external devices unless they were brought into… Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Arthrex IBalance TKA Tibial Tray Size 2 Devices reported to have a smooth texture to the outer surface of the metal, which differed from a previous that had a textured outer surface. Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Covidien Dover CATCH KIT SOAP Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Dover 4.5OZ MIDSTREAM W/CASTILE TOWL Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Dover 7 OZ MIDSTREAM W/CAST SOAP Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Dover EASY CATCH MIDSTREAM KT W/CAST Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Dover MIDSTREAM KIT CASTILE SOAP Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Dover MIDSTREAM KIT CASTILE SOAP Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Dover MIDSTREAM KIT RING CASTILE Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Dover KIT/STERILE PRESERVE CULT Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Dover PREM U/M 14FR SIL FLY Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Dover PREM U/M 14FR TMP SNS CSD Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Dover PREM U/M 14FR SLVR FLY Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Dover P400 PREM U/M 16FR SIL COUDE CATH SECURE Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Dover P400 UM 16FR SIL COUDE SECURE Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Dover P400 PREM U/M 16FR SIL FLY Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Dover P400 PREM U/M 16FR TMP SNS CSD Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Dover P400 PREM U/M 16FR UL FOLY CSD Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Dover P400 PREM U/M 16FR SLVR FLY Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Dover P400 PREM UM 16FR SILV TMP CSD Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Dover P400 PREM U/M 18FR SIL COUDE CATH SECURE Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Dover P400 UM 18FR SIL COUDE SECURE Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Dover P400 PREM U/M 18FR SIL FLY Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Dover P400 PREM U/M 18FR UL FOLY CSD Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Dover ¿18 FR/CH SILVER-HYDROGEL COATED SILICONE FOLEY CATHETER WITH COUD¿ TIP PRE-CONNECTED TO 400… Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Dover 400 PREM U/M 18FR SLVR FLY Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Dover PRECSION PRM 14FR SIL FLY Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Dover PREC PRM 14FR SILVER FLY TY Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Dover PRECISION PRM 16FR SIL COUDE CATH SECURE Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Dover PRECSION PRM 16FR SIL FLY Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2016ClassClass 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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