🏥 Medical Devices Class I - Dangerous
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
All Recalls
95,075 total recalls in our database
🏥 Medical Devices Class I - Dangerous
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
🏥 Medical Devices Class I - Dangerous
Products expire prior to the expiration date printed on the product labeling
Hand Pack, AKHD97C; Medical convenience kit
American Contract Systems
🏥 Medical Devices Class I - Dangerous
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 product sterilization assurance requirements were met.
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
Fresenius Kabi USA
🏥 Medical Devices Class I - Dangerous
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.
🏥 Medical Devices Class I - Dangerous
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
🏥 Medical Devices Class I - Dangerous
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
🏥 Medical Devices Class I - Dangerous
Products expire prior to the expiration date printed on the product labeling
🏥 Medical Devices Class I - Dangerous
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
🏥 Medical Devices Class I - Dangerous
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 infections caused by E. coli,
The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.
Vaginal Delivery, ASDV25B; Medical convenience kit
American Contract Systems
🏥 Medical Devices Class I - Dangerous
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 product sterilization assurance requirements were met.
Reports have been received regarding open seals on the packaging.
🏥 Medical Devices Class I - Dangerous
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
IR Procedure Pack, CEAT19W; Medical convenience kit
American Contract Systems
🏥 Medical Devices Class I - Dangerous
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 product sterilization assurance requirements were met.
🏥 Medical Devices Class I - Dangerous
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Custom Procedure Kit, REF: K12T-11077
Merit Medical Systems
🏥 Medical Devices Class I - Dangerous
7F sheath introducers labeled as 7.5F
🏥 Medical Devices Class I - Dangerous
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Nasal Sinus Pack, MTSN26B; Medical convenience kit
American Contract Systems
🏥 Medical Devices Class I - Dangerous
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 product sterilization assurance requirements were met.
🏥 Medical Devices Class I - Dangerous
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 horizontal tabletop. May lead to delay in diagnosis and/or may include anxiety of a patient is left on the tabletop inside the bore for a longer duration than anticipated. movement.