Complete FDA and NHTSA recall records dated in October 2024.
These records include useful source details for the selected month.
Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the…
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the…
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.
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…
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…
GE HealthCare has become aware that complete electrical safety testing was not conducted during manufacturing of certain Giraffe and Panda iRes Warmers. There are multiple electrical safety…
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.
During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that may not have been fully evaluated in the…
Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the…
Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the…
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…
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.
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…
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Reports have been received regarding open seals on the packaging.
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…
The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.
Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD Phoenix" 100, may lead to misdiagnosis and inappropriate treatment of…
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Products expire prior to the expiration date printed on the product labeling
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.
