🏥 Medical Devices Class I - Dangerous
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
All Recalls
95,018 total recalls in our database
🏥 Medical Devices Class I - Dangerous
The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
🏥 Medical Devices Class I - Dangerous
The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically removed while the battery is being charged. This occurs during a very specific set of conditions.
Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultrasound procedures.
Accelerated Care Plus
🏥 Medical Devices Class I - Dangerous
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health
BF-P60 OES Bronchofiberscope, Model No. BF-P60
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU
Aesculap Implant Systems
🏥 Medical Devices Class I - Dangerous
Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery
DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set
Deroyal Industries, Inc. Lafollette
🏥 Medical Devices Class I - Dangerous
DeRoyal manufactured procedure packs containing a Smiths Medical NORMOFLO Irrigation Warming System which is recalled due to the potential for aluminum ions leaching into warming fluids.
🏥 Medical Devices Class I - Dangerous
The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
🏥 Medical Devices Class I - Dangerous
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
🏥 Medical Devices Class I - Dangerous
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
Outlook Pump Add-On Set-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: V7400
B. Braun Medical
🏥 Medical Devices Class I - Dangerous
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
BF-Q180-AC EVIS EXERA II Bronchovideoscope, Model No. BF-Q180-AC
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
🏥 Medical Devices Class I - Dangerous
Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is lost the patient can slide backwards and potentially may fall out of the Oct lift sheet back onto the surface it is being lifted from.
VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged
Greiner Bio-One North America
🏥 Medical Devices Class I - Dangerous
Blood collection tubes may experience a clotting issue.
uMI 550 System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.
Shanghai United Imaging Healthcare Co.
🏥 Medical Devices Class I - Dangerous
The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.
🏥 Medical Devices Class I - Dangerous
Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is lost the patient can slide backwards and potentially may fall out of the Oct lift sheet back onto the surface it is being lifted from.
🏥 Medical Devices Class I - Dangerous
The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13
Aesculap Implant Systems
🏥 Medical Devices Class I - Dangerous
Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery
AMX Navigate Mobile X-Ray System
GE Healthcare
🏥 Medical Devices Class I - Dangerous
An unexpected column motion while attempting to park the column on the AMX Navigate mobile X-ray system.
Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, and nutrients; the sampling of blood; and for power injection of contrast media. Catalog Number: 60M701995
Angiodynamics Inc. (Navilyst Medical Inc.)
🏥 Medical Devices Class I - Dangerous
Mislabeled: The product is labeled as 5F (55cm; Maximum Flow Rate 3.5 mL/Sec) and the product is actually 4F (55cm; Maximum Flow Rate 3.5 mL/Sec).