Class IIOngoingZ-1756-2026
Burlington Medical, LLC recalls Burlington Medical
Potential for attenuation degradation over time, decreasing the lifespan.
Burlington Medical, LL…VAApr 8, 2026
Recalls: Process change control
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 97–108 of 117 recalls
Class IIOngoingZ-1755-2026
Burlington Medical, LLC recalls Burlington Medical
Potential for attenuation degradation over time, decreasing the lifespan.
Burlington Medical, LL…VAApr 8, 2026
Class IIOngoingZ-1754-2026
Burlington Medical, LLC recalls Burlington Medical
Potential for attenuation degradation over time, decreasing the lifespan.
Burlington Medical, LL…VAApr 8, 2026
Class IIOngoingZ-1753-2026
Burlington Medical, LLC recalls Burlington Medical
Potential for attenuation degradation over time, decreasing the lifespan.
Burlington Medical, LL…VAApr 8, 2026
Class IIOngoingZ-1703-2026
Synthes (USA) Products LLC recalls 2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US.
A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread.
Synthes (USA) Products…PAApr 8, 2026
Class IIOngoingZ-1702-2026
Synthes (USA) Products LLC recalls 2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.
A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread.
Synthes (USA) Products…PAApr 8, 2026
Class IIOngoingZ-1701-2026
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
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
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