The Guardian System The Guardian recall — FDA Z-1140-2025
Device reaching End of Service prematurely.
Complete FDA and NHTSA recall records dated in February 2025.
These records include useful source details for the selected month.
Device reaching End of Service prematurely.
Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.
A premature failure condition was identified with the L2050R pulse oximeter SpO2 sensor that connects to the L2050G Vios chest sensor device. When a failure occurs, a Pulse Ox Sensor Off…
Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device potentially resulting in minor and…
Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong therapy (dose, item, timing, etc.), or 3) unauthorized access and/or compliance…
Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.
Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted in the release of products that should have failed and been…
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted in the release of products that should have failed and been…
Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Potential that the induction seal is not completely sealed to the device tube packaging.
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Volvo Car USA, LLC (Volvo) is recalling certain 2025 S90 vehicles. The windows may be improperly secured and detach.
may contain metal pieces
may contain metal pieces
Undeclared Red #40 and Potassium Sorbate.
Undeclared Red #40 and Potassium Sorbate
may contain metal pieces
Improper storage temperature.
Undeclared allergen (Milk) in Shirakiku brand Curvee Puffs Corn Puff Snack
Foreign material appears to be white nylon or other plastic thread was found in product.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.