All recalls
- 2026-04-08FDA-DeviceIntuitive Surgical, Inc.Class IIBrand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument Model/Catalog Number: 420179 Software Version: N/A Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, c
Due to increased complaints for broken/frayed grip cables for reusable instruments.
- 2026-04-08FDA-DeviceOlympus Corporation of the AmericasClass IIBrand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog Number: TFL-SLS containing TFL-CSLU Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate soft tissue with moderate hemostasis, little charring, and a thin zone of necrosis. Component: No
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.
- 2026-04-08FDA-DeviceOlympus Corporation of the AmericasClass IIBrand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/Catalog Number: TFL-PLS containing TFL-CPLU Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate soft tissue with moderate hemostasis, little charring, and a thin zone of necrosis. Component: No
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.
- 2026-04-08FDA-DeviceMedline Industries, LPClass IISterile Radiology Procedure Kits, Model Number DYNDH1491B
There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility.
- 2026-04-08FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIVue Motion V12. Product Number: 1017979.
Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence.
- 2026-04-08FDA-DeviceMedline Industries, LPClass IIMedline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE KIT 2. SKU ENFITDISCKIT ENFIT DISCHARGE KIT
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.
- 2026-04-08FDA-DeviceMedline Industries, LPClass IIENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC
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.
- 2026-04-08FDA-DeviceUltradent Products, Inc.Class IIJiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.
Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment.
- 2026-04-08FDA-DeviceStryker CommunicationsClass IIStryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001
Surgical light assembly may not adequate support the weight of the ceiling cover.
- 2026-04-08FDA-DeviceMentor Texas, LP.Class IIArtoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth Ultra High Profile Tissue Expander, 350cc, 455cc, 535cc, 650cc, 700cc, 850cc
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
- 2026-04-08FDA-DeviceMentor Texas, LP.Class IIArtoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-155H Smooth High Profile Tissue Expander, 225cc, 300cc, 375cc, 475cc, 500cc, 600cc, 750cc, 850cc
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
- 2026-04-08FDA-DeviceMentor Texas, LP.Class IIArtoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH Textured, High & Ultra High Profile, Integral Injection Dome, 300cc, 375cc, 535cc, 475cc, 500cc, 600cc, 750cc,
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
- 2026-04-08FDA-DeviceMentor Texas, LP.Class IICPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH Smooth Tall Height Tissue Expander, 350cc, 450cc, 650cc, 750cc
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
- 2026-04-08FDA-DeviceMentor Texas, LP.Class IICPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-127MH, SCPX-135MH, SCPX-146MH, SCPX-156MH Smooth Medium Height Tissue Expander, 275cc, 350cc, 450cc, 550cc, 650cc, 800cc
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
- 2026-04-08FDA-DeviceMentor Texas, LP.Class IICPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
- 2026-04-08FDA-DeviceMentor Texas, LP.Class IICPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
- 2026-04-08FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIAzurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- 2026-04-08FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIAzurion 5 M12; System Code: (1)722227, (2)722231;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- 2026-04-08FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIAzurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- 2026-04-08FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIAzurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- 2026-04-08FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIAzurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- 2026-04-08FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIAzurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- 2026-04-08FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIAzurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- 2026-04-08FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIAzurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- 2026-04-08FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIAllura Xper FD20/15 OR Table; System Code: 722059;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- 2026-04-08FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIAllura Xper FD20/15; System Code: 722058;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- 2026-04-08FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIAllura Xper FD20/20 OR Table; System Code: 722039;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- 2026-04-08FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIAllura Xper FD20/20; System Code: 722038;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- 2026-04-08FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIAllura Xper FD20/10; System Code: 722029;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- 2026-04-08FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.