Medical Devices Recalls

Hazard: The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.

Hazard: Lack of redundant interlocks, missing required labels and certification labels as required by 21 1010.2.

Hazard: The terminal block used to secure the power supply cable for the gradient coil of the MRI system was not secured as designed, which could cause cable disconnection, which could lead to arcing, followed by melting of the cable, ignition, smoke, and fire.

Hazard: There is a potential issue regarding the service handles for the internal lead (Pb) covers in that the handles could loosen or release which could cause a cover to drop potentially resulting in injury to service personnel due to the weight of the cover.

Hazard: Quarantined product was inadvertently distributed

Hazard: Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms.

Hazard: The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.

Hazard: The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.

Hazard: The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.

Hazard: Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.

Hazard: Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.

Hazard: Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.

Hazard: Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.

Hazard: Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.

Hazard: System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, Distorted text, blanks, or zeroes in place of values, Unresponsive buttons where the user is unable to initiate a command, which may lead to anxiety /inconvenience, hemodynamic compromise, extended surgical time, and Pump Stop command may be selected

Hazard: The required leakage test was not performed following of a re-work for a non-conformity. This could potentially result in liquid ingress into the eyepiece and cause a foggy image.

Hazard: Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the same patient may cause electrical noise or interference, which may lead to distortions of the ECG signal; distortions may lead to no or ineffective pacing, or no or inappropriate defibrillation pulse.

Hazard: Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements.

Hazard: Potential for an electrical component of the O-arm" O2 Imaging System to intermittently shut off,failure can cause the potential for surgical delay, additional imaging, cancellation and rescheduling of surgery, or completion of surgery without the benefit of image guidance.

Hazard: Due to software issue the device may give false "SpO2 Probe Failure" alarm

Hazard: There is the potential of the tip protector to fall off 4.5" sterile, curved, Iris Scissors

Hazard: Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing.

Hazard: Due to software issues, their is the potential for loss of image or a degradation of the image when using the monitor with other connectable devices.

Hazard: Due to software issues, their is the potential for loss of image or a degradation of the image when using the monitor with other connectable devices.

Hazard: The results generated by the VITROS Immunodiagnostic Products Vitamin B12 Range Verifier Lot# 1200 RV Level 2 may cause range verification failure. The issue is detectable by the user when the product fails to meet the required range during processing of RV Level 2 of this lot. There is a potential for a delay in patient test results should the user have a need to switch to an alternate method of range verification including use of an alternate lot. As this issue affects the upper limit range verification, there is no impact to VITROS Immunodiagnostic Products Vitamin B12 assay performance. Were the assay to not perform as expected, the failure would be detectable by Quality Control. Past patient sample results are unaffected, and no review of reported results is required.

Hazard: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.

Hazard: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.

Hazard: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.

Hazard: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.

Hazard: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.