🏥 Medical Devices Class I - Dangerous
The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.
All Recalls
95,018 total recalls in our database
SmartPath to dStream for XR and 3.0T, Magnetic Resonance System.
Philips North America
🏥 Medical Devices Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Ingenia 1.5T, Magnetic Resonance System.
Philips North America
🏥 Medical Devices Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Dr¿ger Perseus A500 Anesthesia Workstation
Draeger Medical
🏥 Medical Devices Class I - Dangerous
Unexpected shutdown while operating on battery power.
Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion Model 3010A, c. Protege UK Model 3010E
Smiths Medical ASD
🏥 Medical Devices Class I - Dangerous
Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.
🏥 Medical Devices Class I - Dangerous
Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
GYROSCAN T10-NT, Magnetic Resonance System.
Philips North America
🏥 Medical Devices Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Intera 3.0T Quasar Dual, Magnetic Resonance System.
Philips North America
🏥 Medical Devices Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Ingenia 3.0T, Magnetic Resonance System.
Philips North America
🏥 Medical Devices Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Ingenia Ambition S, Magnetic Resonance System.
Philips North America
🏥 Medical Devices Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
🏥 Medical Devices Class I - Dangerous
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing Product Number: 66803140
Smith & Nephew Medical
🏥 Medical Devices Class I - Dangerous
Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
🏥 Medical Devices Class I - Dangerous
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
🏥 Medical Devices Class I - Dangerous
Retrospective engineering analysis against current ISO standards for hoists has determined: 1. The device cannot physically perform at maximum documented weight specifications when a factor of safety of two times the maximum load is applied. 2. The device is not equipped with a safety device to ensure a person with disability would not fall in the event of a single-fault condition of the lifting device.
Intera 1.5T Master/Nova, Magnetic Resonance System.
Philips North America
🏥 Medical Devices Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Ingenia 3.0T CX, Magnetic Resonance System.
Philips North America
🏥 Medical Devices Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Sant and Abel Children's Two-Piece Pajama Sets
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The children's pajamas fail to meet the flammability standards for children's sleepwear, posing a burn hazard to children.
Gossamer Pro AGX+ cranksets
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The bicycle's crank arms can loosen and/or detach from the crank/spindle, posing fall and injury hazards.
Gasaciods Children's Multi-Purpose Helmets
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The helmets do not comply with the positional stability, dynamic strength of retention system, impact attenuation, and certification requirements in violation of the CPSC federal safety regulation for bicycle helmets. The helmets can fail to protect in the event of a crash, posing a risk of head injury.
Randder 2-Pack Liquid Fuel Bottles
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The portable fuel containers do not meet the child-resistant requirements for closures under the Children's Gasoline Burn Prevention Act (CGBPA). The closure for the products is not child resistant, posing a risk of burns and poisoning to children.