Complete FDA and NHTSA recall records dated in October 2024.
These records include useful source details for the selected month.
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious patient harm or death.
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm…
Products expire prior to the expiration date printed on the product labeling
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data…
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm…
Undeclared allergen (Fish) Ingredient
Products contain undeclared sub ingredient: wheat.
Undeclared soy lecithin and soybean oil on label
Products contain undeclared sub ingredient: wheat.
Products contain undeclared sub ingredients: wheat and milk
Allergen not listed in the Contains statement: Fish
Products contain undeclared sub ingredients: wheat and milk
Undeclared soy lecithin and soybean oil on label
Undeclared allergen (Fish) Ingredient
Products contain undeclared sub ingredients: wheat and milk
BMW of North America, LLC. (BMW) is recalling certain 2023-2024 X1, X5, X6, X7, XM, 530i, i5, 740i, 760i, i7, and 750e vehicles. Please see the recall report for a complete list of models…
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Microbial Contamination of Non-Sterile Product
Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
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.
