95,094 total recalls in our database
Amneal Pharmaceuticals of New York
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
Amring Pharmaceuticals
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Jarman's Midwest Cleaning Systems
CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of methanol in other products.
Jarman's Midwest Cleaning Systems
Chemical Contamination: FDA testing found Presence of methanol
Jarman's Midwest Cleaning Systems
Chemical Contamination: FDA testing found Presence of methanol
Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer connection portion of the dilator hub that cracks or dislodges during use, which renders the dilator component unusable, and can require the use of a replacement device.
Apothecary Products
Potential for glass dropper to have glass particulate on the outside surface of the dropper bulb.
Remote Diagnostic Technologies
Defibrillator/pacemaker module (DPM) may encounter a problem causing communication from the Mainboard to the DPM to fail, leading to no or ineffective pacing with displayed error message "HW failure DPM".
Merit Medical Systems
There is a potential that valve assemblies will not open. preventing fluid from draining.
p-Chip
The laser operation might fall under a higher laser class.
Fails Post-Sterilization Sterile Swabs Cantilever (Bend) Testing and may be more susceptible to breakage. If the swab breaks in the nasal cavity of a patient may cause injury or medical intervention to remove part of the swab
Merit Medical Systems
There is a potential that valve assemblies will not open. preventing fluid from draining.
Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer connection portion of the dilator hub that cracks or dislodges during use, which renders the dilator component unusable, and can require the use of a replacement device.
Apothecary Products
Potential for glass dropper to have glass particulate on the outside surface of the dropper bulb.
The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU.
Merit Medical Systems
There is a potential that valve assemblies will not open. preventing fluid from draining.
Merit Medical Systems
There is a potential that valve assemblies will not open. preventing fluid from draining.
A mechanical lock used to connect and release a locking liner into a prosthetic socket have an attachment pin and lock that can wear down faster than expected, leading to the potential for the pin to disengage from the lock, leading to loss of suspension of the external prosthetic system that replaces a missing lower limb, which can lead to falling and injury.
Merit Medical Systems
There is a potential that valve assemblies will not open. preventing fluid from draining.