Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
All Recalls
95,102 total recalls in our database
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
💊 Drugs Class I - Dangerous
Failed impurities/Degradation specifications: out of specification results for individual unknown and total impurity at the 12th month room temperature stability test station
🏥 Medical Devices Class I - Dangerous
Recall being initiated in response to three reports of "Burst Watchdog Timeout" events occurring with the Model 106 AspireSR Generator, resulting in a device reset condition where stimulation output is disabled.
🏥 Medical Devices Class I - Dangerous
One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip are being recalled due to a lowered reaction rate in the reagent pad for glucose. The affected lots will display a result of approximately 300 to 400 mg/dL for any glucose value that exceeds the upper limit of 416 mg/dL.
🏥 Medical Devices Class I - Dangerous
Potential for the female luer component of the InVision-Plus IV connector to crack during use.
🏥 Medical Devices Class I - Dangerous
The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.
🏥 Medical Devices Class I - Dangerous
The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.
🏥 Medical Devices Class I - Dangerous
Software Error: The effect of setup on overall navigation accuracy could potentially intensify small inaccuracies arising from individual steps of a complex navigation procedure that may cause an inaccurate display of instruments by the navigation system compared to the actual patient anatomy.
🏥 Medical Devices Class I - Dangerous
Potential for the female luer component of the InVision-Plus IV connector to crack during use.
🏥 Medical Devices Class I - Dangerous
When not used correctly, Accusorb MRI products may overheat and lead to patient injury.
🏥 Medical Devices Class I - Dangerous
When not used correctly, Accusorb MRI products may overheat and lead to patient injury.
Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for long term attachment to an Implantable Cardioverter Defibrillator (ICD).
St Jude Medical Cardiac Rhythm Management Division
🏥 Medical Devices Class I - Dangerous
Leads may have been compromised during the manufacturing process, with cuts in the insulation layer of the SVC shock coil.
🏥 Medical Devices Class I - Dangerous
When not used correctly, Accusorb MRI products may overheat and lead to patient injury.
The e.cam Dual Signature Gamma Camera system. Used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
To provide operator instruction manuals for the e.cam Dual Signature; Gamma Camera that were not sent in its entirety when the e.cam systems were refurbished and shipped to the customer.
Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator, SPAG-2 6000 series. Model No. SPAG-2. A nebulizer pneumatic flow system for the administration of Virazole (ribavirin) aerosol.
Valeant Pharmacueticals International
🏥 Medical Devices Class I - Dangerous
The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is incorrect or out of date, including references to accessories that are no longer available.
IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2
Iba Dosimetry Gmbh
🏥 Medical Devices Class I - Dangerous
When the electric lift table is connected to the mains power, in a very rare occasion, the table may start to move up in an uncontrolled manner.
🏥 Medical Devices Class I - Dangerous
When not used correctly, Accusorb MRI products may overheat and lead to patient injury.
FMS neXtra¿ 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
DePuy Mitek, Inc., a Johnson & Johnson
🏥 Medical Devices Class I - Dangerous
Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
Accusorb MRI MAC7030 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
MWT Materials
🏥 Medical Devices Class I - Dangerous
When not used correctly, Accusorb MRI products may overheat and lead to patient injury.