April 1, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 92000
Hazard: 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.
April 1, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK Prod
Hazard: 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.
April 1, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HA
Hazard: 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.
April 1, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Pro
Hazard: 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.
April 1, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar Cutting Forceps Mo
Hazard: 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.
April 1, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Ca
Hazard: 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.
April 1, 2026Medical DevicesFDA
Tandem Diabetes Care, Inc. recalls Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize
Hazard: 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.
April 1, 2026Medical DevicesFDA
Medtronic MiniMed, Inc. recalls MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61
Hazard: 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).
April 1, 2026Medical DevicesFDA
AMO Puerto Rico Manufacturing, Inc. recalls Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Sim
Hazard: 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.
April 1, 2026Medical DevicesFDA
Straumann USA LLC recalls Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;
Hazard: 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.
April 1, 2026Medical DevicesFDA
Straumann USA LLC recalls Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
Hazard: 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.
April 1, 2026Medical DevicesFDA
Koven Technology, Inc. recalls Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: E
Hazard: Product labeling includes a fetal indication for use that is not cleared under its 510(k).
April 1, 2026Medical DevicesFDA
Orthalign, Inc recalls Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System
Hazard: Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
April 1, 2026Medical DevicesFDA
Orthalign, Inc recalls Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System
Hazard: Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
April 1, 2026Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips X7-2 Ultrasound Transducer
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
April 1, 2026Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips X3-1 Ultrasound Transducer
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
April 1, 2026Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips S5-2 Ultrasound Transducer
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
April 1, 2026Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips S4-1 Ultrasound Transducer
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
April 1, 2026Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips OMNI III TEE Ultrasound Transducer
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
April 1, 2026Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips OMNI II TEE Ultrasound Transducer
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
April 1, 2026Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips Mini Multi TEE Ultrasound Transducer
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
April 1, 2026Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips L17-5 Ultrasound Transducer
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
April 1, 2026Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips L12-5 Ultrasound Transducer
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
April 1, 2026Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips C9-4 Ultrasound Transducer
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
April 1, 2026Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips 3D6-2 Ultrasound Transducer
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
April 1, 2026Medical DevicesFDA
Philips Respironics, Inc. recalls Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
Hazard: 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.
April 1, 2026Medical DevicesFDA
Philips Respironics, Inc. recalls Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
Hazard: 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.
April 1, 2026Medical DevicesFDA
Philips Respironics, Inc. recalls Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
Hazard: 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.
April 1, 2026Medical DevicesFDA
Philips Respironics, Inc. recalls Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
Hazard: 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.
April 1, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
Hazard: The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.