Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS C...
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 L12-5 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips OMNI II TEE Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-...
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.
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component L...
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
Tandem pumps are battery-operated infusion pumps capable of both basal and bolus...
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.
Philips Mini Multi TEE Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Brand Name: Humeral Head Plate with Angular Stability, with the following descri...
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H7...
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.
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuo...
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.
16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-0...
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.
Philips X3-1 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Claviculaplate with Angular Stability, with the below descriptions and associate...
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
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
Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with t...
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Nin...
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.
Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product ...
Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as consistently as expected.
Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027...
A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.
I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions a...
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENF...
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.
Philips L17-5 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.