Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
All Recalls
95,114 total recalls in our database
🏥 Medical Devices Class I - Dangerous
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.
🏥 Medical Devices Class I - Dangerous
Probes may rupture/burst during activation
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C
Merit Medical Systems
🏥 Medical Devices Class I - Dangerous
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.
🏥 Medical Devices Class I - Dangerous
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.
Philips S4-1 Ultrasound Transducer
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP
GE Medical Systems
🏥 Medical Devices Class I - Dangerous
There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
Philips Respironics
🏥 Medical Devices Class I - Dangerous
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.
Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
🏥 Medical Devices Class I - Dangerous
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
Philips X3-1 Ultrasound Transducer
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips OMNI II TEE Ultrasound Transducer
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Product Description: An assembly of devices intended to generate and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure.
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
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.
🏥 Medical Devices Class I - Dangerous
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).
Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
Waldemar Link GmbH & Co. KG (Mfg Site)
🏥 Medical Devices Class I - Dangerous
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 (bulk, non-sterile), REF: FCL-174-00/B
Merit Medical Systems
🏥 Medical Devices Class I - Dangerous
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.
🏥 Medical Devices Class I - Dangerous
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.