Medical Device Recalls
The most recent FDA medical-device recalls affecting healthcare technology, gathered from the openFDA device enforcement database.
Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction req
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction req
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction req
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction req
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130 (Upgrade);
Class IIA software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction req
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction req
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction req
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction req
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction req
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction req
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction req
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction req
Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU).
Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under delivery
The proximal thread depth of the spinal device is out of design specification.
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
Class IIPotential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm,
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
Reusable access port system may crack or seperate during use.
Reusable access port system may crack or seperate during use.
Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation.
Reusable access port system may crack or seperate during use.
Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.
REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM
Class IIReusable access port system may crack or seperate during use.
Reusable access port system may crack or seperate during use.
Reusable access port system may crack or seperate during use.
There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved pro
There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved pro
There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved pro
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP).
A small number of lenses within the affected lot are of the incorrect power.
The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
GM Helix Implant, REF: 109.984;
Class IIThere is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pre
Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables.
Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pre
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the