Medical Devices Recalls

16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.

Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.

The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which could result in a risk of hypoglycemia or hyperglycemia due to inaccuracies in insulin delivery (either under-delivery, over-delivery, or cessation of delivery).

The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.

16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.

The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set is connected to the body, when it should instead direct users to confirm that the infusion set is not connected to the body. Following this instruction could result in unintended insulin delivery, potentially leading to a hypoglycemic event.

The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.

If heating pad is folded while in use, the power density increases in the folded area causing excessive temperatures, which can also be caused by placing pad under the body, then the high limit device is unable to sense the higher temperature so power is not terminated. May cause a burning smell prior to melting/burning potentially causing burns to persons and property.

The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.