💊 Drugs Class I - Dangerous
cGMP Deviations
All Recalls
95,018 total recalls in our database
Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
Medtronic Neuromodulation
🏥 Medical Devices Class I - Dangerous
Specific PINs of the Vectris SureScan MRI lead kits contain the incorrect lead electrode spacing information printed on the shelf box and the sterile pack labeling.
🏥 Medical Devices Class I - Dangerous
There is a potential for the Anti-free flow clip of the administration set to be inverted which may cause unintended free flow if the user fails to follow on screen prompt to close the roller clamp prior to set removal from the pump.
Proteus 235-Proton Therapy System
Ion Beam Applications S.A.
🏥 Medical Devices Class I - Dangerous
if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated as prescribed, the treatment field may be delivered with an error in position
SPECSAVERS UMERE TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blocker
CooperVision
🏥 Medical Devices Class I - Dangerous
Misaligned placement of an axis mark can cause the patient to experience blurred vision
🏥 Medical Devices Class I - Dangerous
Out of Specification
AQUATECH PLUS 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker
CooperVision
🏥 Medical Devices Class I - Dangerous
Misaligned placement of an axis mark can cause the patient to experience blurred vision
FRESH DAY 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blocker
CooperVision
🏥 Medical Devices Class I - Dangerous
Misaligned placement of an axis mark can cause the patient to experience blurred vision
CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
CooperVision
🏥 Medical Devices Class I - Dangerous
Misaligned placement of an axis mark can cause the patient to experience blurred vision
CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
CooperVision
🏥 Medical Devices Class I - Dangerous
Misaligned placement of an axis mark can cause the patient to experience blurred vision
🏥 Medical Devices Class I - Dangerous
During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.
Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extracorporeal circulation and for blankets with which patients can be warmed or cooled.
Maquet Medical Systems USA
🏥 Medical Devices Class I - Dangerous
There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including Mycobacteria species.
🏥 Medical Devices Class I - Dangerous
There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplete early causing the system to become inoperable.
Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
🏥 Medical Devices Class I - Dangerous
The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.
Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
CLARITI 1 DAY TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blocker
CooperVision
🏥 Medical Devices Class I - Dangerous
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016. Hyperthermic Perfusion System intended to raise the temperature of the thoracic or peritoneal cavity to a target temperature.
Eight Medical International BV
🏥 Medical Devices Class I - Dangerous
The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.
CARESCAPE PDM-Masimo SpO2. Physiological data monitor.
GE Healthcare
🏥 Medical Devices Class I - Dangerous
Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down.
basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.
Merit Medical Systems
🏥 Medical Devices Class I - Dangerous
Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.