Others titles
- FDA Medical Devices Recalls 2015
- FDA Medical Devices Recalls
Keywords
- Devices Recalls
- FDA Recalls
- Medical Devices
- Medical Devices Recalls
- Medical Device Recalled Products
- Devices Recalls
- FDA Recalls
Medical Devices Recalls
The Food and Drug Administration Medical Devices Recalls dataset contains a complete list of recalls that were issued since 2015.
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Description
The FDA posts consumer information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could cause serious health problems or death. FDA works with industry and our state partners to publish press releases and other public notices about recalls that may potentially present a significant or serious risk to the consumer or user of the product. Full details about each recall reasons are available in the related link under “Information_Link” Column.
About this Dataset
Data Info
Date Created | 2015-01-08 |
---|---|
Last Modified | 2022-06-07 |
Version | 2022-06-07 |
Update Frequency |
Irregular |
Temporal Coverage |
2015-01 to 2024-16 |
Spatial Coverage |
United States |
Source | John Snow Labs; U.S. Food and Drug Administration (FDA); |
Source License URL | |
Source License Requirements |
N/A |
Source Citation |
N/A |
Keywords | Devices Recalls, FDA Recalls, Medical Devices, Medical Devices Recalls, Medical Device Recalled Products, Devices Recalls, FDA Recalls |
Other Titles | FDA Medical Devices Recalls 2015, FDA Medical Devices Recalls |
Data Fields
Name | Description | Type | Constraints |
---|---|---|---|
Device_Name | Name of recalled Device | string | - |
Device_Description | Description of the recalled Device | string | required : 1 |
Recall_Posted_Date | Date of recall | date | required : 1 |
Company_Name | Name of the manufactoring company. | string | required : 1 |
Recall_Reason | Reason of the recall. | string | required : 1 |
Information_Link | The link contains more details about the product and recall reasons. | string | required : 1 |
Data Preview
Device Name | Device Description | Recall Posted Date | Company Name | Recall Reason | Information Link |
The AMS 700 Inflatable Penile Prosthesis | The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system containing saline. The system is made out of silicone and consists of 4 main components: a pump, two cylinders, a fluid reservoir and kink-resistant tubing that is used to connect the pump to the cylinders and fluid reservoir. By pumping the fluid within the system from the reservoir via the pump and into the cylinders, the product creates an erection in men who have chronic, organic, erectile dysfunction. Part Number: 720185-01, 72404156 | 2021-04-16 | Boston Scientific Corporation | An AMS 700 100 mL Spherical Reservoir with InhibiZone was incorrectly labeled as a 100 mL Conceal Reservoir with InhibiZone. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=186737 |
Bard Clean-Cath Intermittent Catheter | Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological use only. | 2021-04-16 | C.R. Bard, Inc. | The device catheter tip was cut off (no tip) and the product packaging was not fully sealed. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=185461 |
HeartWare HVAD System | Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system components:HVAD Sterile Implant Kit, Model Numbers: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, MCS1705PUHVAD Controller Kit, Model Numbers: 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, 1420JPHVAD AC Adapter Controller, Model Numbers: 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, 1430USHVAD DC Adapter Controller: Model Number: 1440HVAD DATA CABLE 1575- MONITOR, Model Number: 1575HVAD Battery Pack, Model Numbers: 1650, 1650CA-CLIN, 1650DEHeartWare Patient Pack, Model Number: 1475HeartWare Waist Pack, Model Numbers: 2050, 2050IL, 2050OUSHeartWare Shoulder Pack, Model Numbers: 2060, 2060IL, 2060OUSThe HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned. | 2021-04-16 | Heartware, Inc. | Medtronic HeartWare HVAD System Instructions for Use (IFU) and Patient Manual (PM) updates regarding: Carrying Cases, Driveline Cover Orientation, and Controller Power Up Sequence issues. The PM is being updated to clarify use of the support strap and wear instructions in addition to cleaning instructions of the carrying cases. The IFU and PM are being updated to add a useful life for the carrying cases. The PM is being updated to inform users to keep the driveline cover on when disconnecting and reconnecting the driveline. The IFU and PM are being updated to clarify the power-up sequence that causes the alarm indicator LEDs and both sets of battery LEDs to turn red for 2.5 seconds while the LCD displays the power-on message. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87603 and 87604 | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=186062 |
Fastep and Ecotest (authorized brand names for Assure COVID-19 IgG/IgM Rapid Test Device) | Assure COVID-19 IgG/IgM Rapid Test Devicethat include:1) Pouch Label - FaStep Rapid Diagnostic Test *** Rapid Reliable Simple *** COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) *** For Emergency Use Authorization Only,Box Label - FaStep Rapid Diagnostic Test *** COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) *** For Emergency Use Authorization Only *** For in vitro diagnostic use only,and 2) Pouch Label - ECOTEST RAPID DIAGNOSTIC TEST *** /Rapid / Reliable / Simple/ *** COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) *** For Emergency Use Authorization Only,Box Label - ECOTEST RAPID DIAGNOSTIC TEST *** Rapid Reliable Simple *** COVID-19 IgG/IgM Rapid Test Device *** For Professional in vitro diagnostic use only *** For Emergency Use Authorization Only. | 2021-04-16 | AZURE BIOTECH INC | Due to Products being incorrect labeling "for diagnostic use" and labelled with an unsupported 24 month expiration dating. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=186253 |
MAMBA Microcatheter | MAMBA Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to the carton. | 2021-04-15 | Boston Scientific Corporation | The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=186251 |
MAMBA Flex 135 Microcatheter | MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to the carton. | 2021-04-15 | Boston Scientific Corporation | The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=186250 |
Stryker Video Processor/Illuminator (VPI) | Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical Device, UDI: (01) 00858701006049 - Product Usage: used with both the SPY-PHI and PINPOINT systems, the intended use for both imaging systems are being documented here. | 2021-04-15 | Stryker Corporation | Their is a potential that Video Processor/Illuminators may exhibit flickering, loss of image or unintended reboots. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=186249 |
RayStation | RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B (10.1.0.613) | 2021-04-15 | RAYSEARCH LABORATORIES AB | Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat. | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=186723 |
Covidien | Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system. Staple line reinforcement has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures, and for transection and resection of pancreas.Product Number: SIGTRSB60AMT | 2021-04-13 | Covidien Llc | Potential for the pouch to contain an extra laminate layer, creating the potential for the device sterility to be compromised. The inclusion of an additional laminate layer in the package may also impact complete de-gassing of the sterilization gas, Ethylene Oxide and may result in a potentially increased risk for patient infection and/or potential exposure to Ethylene Oxide retained in the pouch | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=186407 |
Disposable Sampling Tube | Dasky Disposable Sampling Tube, REF VSM02, Contents: Transport Media - 50, Nasal swab - 50, Package Insert - 1, IVD, CE | 2021-04-13 | Krishe Inc | Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=186378 |