Medical device recalls

Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.

Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.

Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.

Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.

intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calibration attempt following the 15-minute warm-up period. The control sliders on the Central Control Monitor (CCM) are disabled and the gas system can only be controlled by the local control knobs

Weld failure- the bracket attaches the tabletop tilting actuator to the tabletop frame. If the bracket weld fails, the tabletop tilting action is non-functional

Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement

Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury

Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury

Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury

Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury

Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury

Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury

Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury

Complaints received concerning Balloon Catheter leakage from the guidewire lumen and the y-hub during preparation resulting in either insufficient inflation or an inability to inflate.

There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of Federal Regulations section 21CFR801.437.

There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of Federal Regulations section 21CFR801.437.

There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of Federal Regulations section 21CFR801.437.

Product label intended for the European community was distributed to the USA market via their US distribution organization

The kit contains the wrong vial tray in the package.

510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles.

Complaints have been received for performance issues related to high background and staining. this issues is related to a manufacturing process error that can potentially cause a false positive staining due to contamination with another antibody.

There is a potential that the data management system may add additional cells to the patient request which could lead to erroneous patient result.

Complaints have been received concerning the humeral stem failing to mate with the broach handles for a shoulder device. This could result in delay of procedure or revision surgery.

Scope tube tip may detach from the telescoping tube, which is attached to a single-use handpiece, a component of an aquablation robotic system. Both tip detachment and entire tip separation form the handpiece may lead to procedural delay for handpiece exchange. Tip detachment can be seen cystoscopically and tip separation from the handpiece may necessitate tip removal from the bladder or prostate.

Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.

Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.

Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.

The internal profile of the Triathlon Prim (Baseplate) is potentially oversized; there may be a witness mark (taper) at the bottom of the internal profile of the baseplate, which prevents the insert from locking on the baseplate.

Potential for leaks and loosening at the patient catheter connection