Philips SmartPath to dStream for 3.0T recall — FDA Z-1789-2025
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Complete FDA and NHTSA recall records dated in 2025, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
AI-powered bacterial culture plate interpretation and workup software does not have Premarket Approval or pre-market notification (510(k)/de novo), so there is potential risk that the…
Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with…
Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Imaging system data may be displayed with an incorrect orientation (sidedness) where the patient side is not correct (left, right, superior, inferior, anterior or posterior). This may lead…
Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.
Salsa products are recalled due to potential contamination with wood particles.
Salsa products are recalled due to potential contamination with wood particles.
Salsa products are recalled due to potential contamination with wood particles.
Salsa products are recalled due to potential contamination with wood particles.
Undeclared allergen (soy) due to mislabeling. Product is labeled as Brown Sugar Molasses Baked Beans, but contains Beef and BBQ Baked Beans. The Beef and BBQ Baked Beans contain soy, which…
Salsa products are recalled due to potential contamination with wood particles.
Product contains undeclared almond and cashew.
Salsa products are recalled due to potential contamination with wood particles.
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.