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 8, 2026.
3,246of 3,246 medical device recallsshown with your filters
The list
- Medical device recall Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD Otto Bock HealthCare GmbH is recalling Modular Polycentric EBS Knee Joint that were serviced between 27 April 2015 and 17 November 2015 due to a service error… Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac troponin I in… Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitative measurement of N-terminal… Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens Acute Care DDMR TestPak Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens Acute Care” MYO TestPak-in vitro diagnostic test for the quantitative measurement of myoglobin in… Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measurement of the MB isoenzyme of creatine… Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens Acute Care” CCRP TestPak-in vitro diagnostic product intended to be used for calibration of the CCRP… Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be used for calibration of the… Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens Acute Care CCRP CalPak-in vitro diagnostic product intended to be used for calibration of the CCRP… Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be used for calibration of the… Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens Acute Care MYO DilPak Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be used in conjunction with the… Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Merge Hemo with software versions 10.0 LA The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house. Class IIFDA’s classJan 6, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereIllinois, North Carolina and Vermont
- Medical device recall Merge Cardio with software version 10.1 LA. The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house. Class IIFDA’s classJan 6, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereIllinois, North Carolina and Vermont
- Medical device recall Granada Biphasic Broth The product is a selective medium for the screening and identification of… FDA has determined that the product requires 510(k) clearance to continue marketing/distribution in the United States. Class IIFDA’s classJan 6, 2016in FDA’s Enforcement Report9 statesnamed in where it went PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Indiana, Massachusetts, Minnesota, Missouri, New York, Ohio and Pennsylvania
- Medical device recall MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for… Incorrect drug dosage due to “Age Limit” and patient weight data item issue. Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, 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, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall MicroScan Pos Combo Panel Type 21 Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture… Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MicroScan Pos Combo Panel Type 33 Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture… Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MicroScan Pos Combo Panel Type 34 Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture… Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MicroScan Pos Breakpoint Combo Panel Type 20 Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture… Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MicroScan Pos Breakpoint Combo Panel Type 23 Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture… Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5 The firm has received 15 complaints over ten years related to the connection of the spring arm to the top horizontal arm of the lighting system that while… Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedJan 6, 2016ClassClass IIStatusCompletedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Maine, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall Radiographic Transparency for Certain and External Connection Tapered Implants Images contained within radiographic transparency ART 1036 are undersized. Class IIFDA’s classJan 6, 2016in FDA’s Enforcement Report16 statesnamed in where it went PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Hawaii, Illinois, Massachusetts, Michigan, Missouri, New York, Ohio, Puerto Rico, South Carolina, Texas, Virginia, Wisconsin and West Virginia
- Medical device recall RenovoCath RC 120 Incorrect version of Instructions for Use were shipped to two US customers. Class IIFDA’s classJan 6, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereCalifornia and Florida
- Medical device recall Valve XS Atrium Retractor FC429R 52154756 The Valve XS Atrium Lift Retractor is used in heart surgery AAG received a customer complaint that corrosion had been found by a hospitals central sterile service department on the ball joint of an FC424R blade. Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereNew York
- Medical device recall BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray… Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additive. Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray… Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additive. Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 3.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray… Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additive. Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 3.0 mL (Tan) BD Hemogard Additive: K2EDTA (spray… Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additive. Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 6, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 4.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray… Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additive. Class IIFDA’s classJan 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 6, 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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