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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.
Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.
Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with frame. This may cause loss of deformity correction and/or disruption of bone regeneration.
Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and Bactec bottle plastic both have an expiration date that does not match the date listed on the kit.
Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and Bactec bottle plastic both have an expiration date that does not match the date listed on the kit.
Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and Bactec bottle plastic both have an expiration date that does not match the date listed on the kit.
Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and Bactec bottle plastic both have an expiration date that does not match the date listed on the kit.
Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and Bactec bottle plastic both have an expiration date that does not match the date listed on the kit.
An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking component material properties and certain use conditions. Unsuccessful clip procedure can lead to recurrence of severe mitral regurgitation, device embolization, or tissue injury.
An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking component material properties and certain use conditions. Unsuccessful clip procedure can lead to recurrence of severe mitral regurgitation, device embolization, or tissue injury.
An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking component material properties and certain use conditions. Unsuccessful clip procedure can lead to recurrence of severe mitral regurgitation, device embolization, or tissue injury.
Product pouch label does not match up with carton label
Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irrigation path with cellulose fibers that can cause 1) Failure of initial flushing inspection, 2) Insufficient irrigation causing catheter tip temperature increase, limiting the ability to deliver ablation, or 3) particles flushed through the catheter irrigation may have thrombogenic/toxic effect.
Device may intermittently fail to produce audio. Turning the unit off and on does not resolve the issue; disconnecting and reconnecting to AC power does not reliably resolve the issue.
No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
COVID test kit shelf life was periodically extended, as real-time stability test timepoints passed, without FDA concurrence.