Class IOngoingZ-0939-2026
Alcon Research LLC recalls Brand Name: Alcon Laboratories
Ophthalmic procedure packs may have incomplete seals affecting sterility.
Alcon Research LLCTXDec 31, 2025
2025 device recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 37–48 of 2,908 recalls
Class IOngoingZ-0934-2026
Draeger, Inc. recalls Draeger Vapor 3000. Unheated
A certain component of affected devices was not delivered within specification and contained impurities.
Draeger, Inc.PADec 31, 2025
Class IOngoingZ-0933-2026
Draeger, Inc. recalls Draeger Vapor 2000. Unheated
A certain component of affected devices was not delivered within specification and contained impurities.
Draeger, Inc.PADec 31, 2025
Class IIOngoingZ-0923-2026
AGFA Healthcare Corp. recalls Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common N…
It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on the NX workstation when ABS is not enabled.
AGFA Healthcare Corp.SCDec 31, 2025
Class IIOngoingZ-0961-2026
Abbott Laboratories recalls Alinity ci-series System Control Module (SCM)
Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction.…
Abbott LaboratoriesTXDec 24, 2025
Class IIOngoingZ-0960-2026
Cepheid recalls Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
CepheidCADec 24, 2025
Class IIOngoingZ-0959-2026
Cepheid recalls Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
CepheidCADec 24, 2025
Class IIOngoingZ-0958-2026
Medtronic MiniMed, Inc. recalls InPen App
When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't choose to allow notifications to override phone settings when on mute/Do…
Medtronic MiniMed, Inc…CADec 24, 2025
Class IIOngoingZ-0957-2026
Smith & Nephew, Inc. recalls BIOSURE HA SCREW
Removal of affected lot of screws due to labeling error.
Smith & Nephew, Inc.MADec 24, 2025
Class IIOngoingZ-0956-2026
Myofunctional Research Company USA recalls Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/L…
Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.
Myofunctional Research…CADec 24, 2025
Class IIOngoingZ-0955-2026
Rocket Medical Plc recalls Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray Model/…
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Rocket Medical PlcDec 24, 2025
Class IIOngoingZ-0954-2026
Rocket Medical Plc recalls Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray Model/…
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Rocket Medical PlcDec 24, 2025