April 8, 2026Medical DevicesFDA
Intuitive Surgical, Inc. recalls Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instru
Hazard: Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
April 8, 2026Medical DevicesFDA
Intuitive Surgical, Inc. recalls Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum Forceps Instrument Mode
Hazard: Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
April 8, 2026Medical DevicesFDA
Intuitive Surgical, Inc. recalls Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping Retractor Instrument Mo
Hazard: Due to increased complaints for broken/frayed grip cables for reusable instruments.
April 8, 2026Medical DevicesFDA
Intuitive Surgical, Inc. recalls Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument Mo
Hazard: Due to increased complaints for broken/frayed grip cables for reusable instruments.
April 8, 2026Medical DevicesFDA
Intuitive Surgical, Inc. recalls Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, Si Double Fenestrated Graspe
Hazard: Due to increased complaints for broken/frayed grip cables for reusable instruments.
April 8, 2026Medical DevicesFDA
Intuitive Surgical, Inc. recalls Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scisso
Hazard: Due to increased complaints for broken/frayed grip cables for reusable instruments.
April 8, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog
Hazard: Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.
April 8, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/
Hazard: Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.
April 8, 2026Medical DevicesFDA
Medline Industries, LP recalls Sterile Radiology Procedure Kits, Model Number DYNDH1491B
Hazard: There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility.
April 8, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Vue Motion V12. Product Number: 1017979.
Hazard: Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence.
April 8, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE KIT 2. SKU ENFITDISCKIT ENFIT DISCH
Hazard: Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in delayed care and fluid loss. Additional consequences may also occur if user over-tightens the connector to stop the leakage, including additional clinical intervention, risk of infection, patient discomfort, and prolonged recovery process.
April 8, 2026Medical DevicesFDA
Medline Industries, LP recalls ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC
Hazard: Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in delayed care and fluid loss. Additional consequences may also occur if user over-tightens the connector to stop the leakage, including additional clinical intervention, risk of infection, patient discomfort, and prolonged recovery process.
April 8, 2026Medical DevicesFDA
Ultradent Products, Inc. recalls Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.
Hazard: Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment.
April 8, 2026Medical DevicesFDA
Stryker Communications recalls Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001
Hazard: Surgical light assembly may not adequate support the weight of the ceiling cover.
April 8, 2026Medical DevicesFDA
Mentor Texas, LP. recalls Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth
Hazard: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
April 8, 2026Medical DevicesFDA
Mentor Texas, LP. recalls Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-1
Hazard: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
April 8, 2026Medical DevicesFDA
Mentor Texas, LP. recalls Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150
Hazard: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
April 8, 2026Medical DevicesFDA
Mentor Texas, LP. recalls CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH Sm
Hazard: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
April 8, 2026Medical DevicesFDA
Mentor Texas, LP. recalls CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-127MH, SCPX-135MH, SCP
Hazard: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
April 8, 2026Medical DevicesFDA
Mentor Texas, LP. recalls CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650
Hazard: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
April 8, 2026Medical DevicesFDA
Mentor Texas, LP. recalls CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tis
Hazard: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
April 8, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);
Hazard: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
April 8, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 5 M12; System Code: (1)722227, (2)722231;
Hazard: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
April 8, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
Hazard: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
April 8, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
Hazard: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
April 8, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
Hazard: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
April 8, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;
Hazard: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
April 8, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);
Hazard: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
April 8, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;
Hazard: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
April 8, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD20/15 OR Table; System Code: 722059;
Hazard: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.