Complete FDA and NHTSA recall records dated in April 2024.
These records include useful source details for the selected month.
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for…
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for…
Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry guide manipulator assembly/instrument arm joints, that may cause the following, 1) Top…
The positive control material (Rhizopus stolonifer) within the KWIK-STIK assembly was contaminated with another fungal organism (Aspergillus brasiliensis). As a result, users may observe A.…
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for…
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for…
Patient lift hanger bar may come loose, which could potentially pose risks to patients.
Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.
Medical device components were marketed without FDA clearance
The product does not meet sterility assurance level.
Insufficient welding leads to the heater cable becoming brittle and present with an error: ERROR 3481 HEATER UNABLE TO REACH TEMPERATURE; the instrument may stop, and the sample being…
Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for…
During an inspection by NCDA, the firm was notified that the label fails list any sub ingredients.
During an inspection by NCDA, the firm was notified that the product label fails to list any sub ingredients.
During an inspection by NCDA, the firm was notified that the label does not list the ingredients for their products.
During an inspection by NCDA, the firm was notified that the label does not list the ingredients for their products.
During an internal investigation the firm discovered that product labeled as Zero Sugar contains full sugar product.
During an inspection by NCDA, the firm was notified that the label fails to declare the allergen egg as an ingredient or in the allergen statement. The firm was also notified that the label…
During an inspection by NCDA, the firm was notified that the product label fails to list any ingredients.
The firm did not complete a hazard analysis for potential C. botulinum growth and toxin production of its processing, storage and shipping of raw onions into vacuum sealed bags.
Undeclared Allergen (peanuts, milk, soy, wheat, and sesame).
The firm was notified that the label did not list any sub ingredients. The product contains pimento cheese which is made with mayonnaise which may include eggs. Undeclared eggs.
During an inspection by NCDA, the firm was notified that the product contains undeclared milk and eggs. The label fails to list any sub ingredients and the contain statement does not list…
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.
