Class IIOngoingZ-1219-2026
LSL Healthcare Inc. recalls LSL Healthcare
BD ChloraPrep Triple Swabsticks, a component within the kits, exhibit an open seal on the packaging of the applicators.
LSL Healthcare Inc.ILFeb 4, 2026
Recalls: Under Investigation by firm
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 421–432 of 1,125 recalls
Class IIOngoingZ-1217-2026
CareFusion 303, Inc. recalls BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM Syste…
Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue with hospital networks.…
CareFusion 303, Inc.CAFeb 4, 2026
Class IIOngoingZ-1202-2026
Zimmer Surgical Inc recalls Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 3200TS Tourniquet Systems…
Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternate device is located.
Zimmer Surgical IncOHFeb 4, 2026
Class IIOngoingZ-1201-2026
Zimmer Surgical Inc recalls Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet Systems…
Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternate device is located.
Zimmer Surgical IncOHFeb 4, 2026
Class IIOngoingZ-1185-2026
NIPRO Technical Services, Inc. recalls Conductivity Standard Solution Catalog/Model Numbers: 10001
due to a defect associated with the conductivity values of the solution used to calibrate meters and result in the reporting of incorrect conductivity values for dialysate.
NIPRO Technical Servic…AZFeb 4, 2026
Class IIOngoingZ-1122-2026
Mazor Robotics Ltd recalls Mazor X robotic guidance system REF: TPL0059
Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
Mazor Robotics LtdJan 28, 2026
Class IIOngoingZ-1110-2026
RAYSEARCH LABORATORIES AB recalls Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs).…
RAYSEARCH LABORATORIES…Jan 28, 2026
Class IIOngoingZ-1109-2026
RAYSEARCH LABORATORIES AB recalls Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0…
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs).…
RAYSEARCH LABORATORIES…Jan 28, 2026
Class IIOngoingZ-1108-2026
RAYSEARCH LABORATORIES AB recalls Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs).…
RAYSEARCH LABORATORIES…Jan 28, 2026
Class IIOngoingZ-1107-2026
RAYSEARCH LABORATORIES AB recalls Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1…
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs).…
RAYSEARCH LABORATORIES…Jan 28, 2026
Class IIOngoingZ-1106-2026
RAYSEARCH LABORATORIES AB recalls Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs).…
RAYSEARCH LABORATORIES…Jan 28, 2026
Class IIOngoingZ-1105-2026
RAYSEARCH LABORATORIES AB recalls Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.…
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs).…
RAYSEARCH LABORATORIES…Jan 28, 2026