Class IIOngoingZ-1700-2026
Intuitive Surgical, Inc. recalls Brand Name: da Vinci S
Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
Intuitive Surgical, In…CAApr 8, 2026
Recalls: Process change control
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 49–60 of 185 recalls
Class IIOngoingZ-1691-2026
Medline Industries, LP recalls Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE 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.…
Medline Industries, LPILApr 8, 2026
Class IIOngoingZ-1690-2026
Medline Industries, LP recalls ENFIT G-TUBE CONNECTOR
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.…
Medline Industries, LPILApr 8, 2026
Class IIOngoingZ-1636-2026
Tandem Diabetes Care, Inc. recalls Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delive…
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 di…
Tandem Diabetes Care,…CAApr 1, 2026
Class IIOngoingZ-1585-2026
Diagnostica Stago, Inc. recalls Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF…
After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.
Diagnostica Stago, Inc…NJMar 25, 2026
Class IIOngoingZ-1355-2026
Intuitive Surgical, Inc. recalls da Vinci 5 Surgeon Console Viewer Display
Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete…
Intuitive Surgical, In…CAFeb 18, 2026
Class IIOngoingZ-1318-2026
Philips North America LLC recalls Spectral CT 7500 on Rails
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification.…
Philips North America…MAFeb 18, 2026
Class IIOngoingZ-1317-2026
Philips North America LLC recalls Spectral CT
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification.…
Philips North America…MAFeb 18, 2026
Class IIOngoingZ-1316-2026
Philips North America LLC recalls IQon Spectral CT
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification.…
Philips North America…MAFeb 18, 2026
Class IIOngoingZ-1315-2026
Philips North America LLC recalls Brilliance iCT
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification.…
Philips North America…MAFeb 18, 2026
Class IIOngoingZ-1139-2026
Community Products, LLC recalls Rifton Equipment
Potential for fraying on the body support strap.
Community Products, LL…NYJan 28, 2026
Class IIOngoingZ-1138-2026
Community Products, LLC recalls Rifton Equipment
Potential for fraying on the body support strap.
Community Products, LL…NYJan 28, 2026