Class IIOngoingZ-0851-2026
Philips North America LLC recalls IntelliVue MP20. Product Number: M8001A.
Potential issue where the IntelliVue monitors did not alarm.
Philips North America…MADec 10, 2025
Recalls: Use error
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 25–36 of 44 recalls
Class IIOngoingZ-0850-2026
Philips North America LLC recalls IntelliVue MP5. Product Number: M8105A.
Potential issue where the IntelliVue monitors did not alarm.
Philips North America…MADec 10, 2025
Class IIOngoingZ-0849-2026
Philips North America LLC recalls IntelliVue MP2. Product Number: M8102A.
Potential issue where the IntelliVue monitors did not alarm.
Philips North America…MADec 10, 2025
Class IIOngoingZ-0211-2026
Cardinal Health 200, LLC recalls Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" PVC Gastrod…
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
Cardinal Health 200, L…ILOct 29, 2025
Class IIOngoingZ-0210-2026
Cardinal Health 200, LLC recalls Salem Sump PVC Tubes: Product Code/Product Name: 266122 Salem Sump" Stomach Tube
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
Cardinal Health 200, L…ILOct 29, 2025
Class IIOngoingZ-0209-2026
Cardinal Health 200, LLC recalls Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Val…
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
Cardinal Health 200, L…ILOct 29, 2025
Class IIOngoingZ-0208-2026
Cardinal Health 200, LLC recalls Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Silicone Dua…
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
Cardinal Health 200, L…ILOct 29, 2025
Class IIOngoingZ-0207-2026
Cardinal Health 200, LLC recalls Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stomach Tube
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
Cardinal Health 200, L…ILOct 29, 2025
Class IIOngoingZ-0206-2026
Cardinal Health 200, LLC recalls Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" P…
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
Cardinal Health 200, L…ILOct 29, 2025
Class IIIOngoingZ-2321-2025
CareFusion 303, Inc. recalls Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137
Reports of delayed access to medication in automated dispensing cabinets because of the override/Add Item workflow.
CareFusion 303, Inc.CAAug 20, 2025
Class IIOngoingZ-2166-2025
CooperVision, Inc. recalls Biofinity Toric Multifocal Contact Lens
Lens blisters may have an incomplete or leaking seal which may render them unsterile.
CooperVision, Inc.NYJul 30, 2025
Class IIOngoingZ-2165-2025
CooperVision, Inc. recalls Biofinity XR Toric Contact Lens
Lens blisters may have an incomplete or leaking seal which may render them unsterile.
CooperVision, Inc.NYJul 30, 2025