💊 Drugs Class I - Dangerous
Failed Dissolution Specifications
All Recalls
92,900 total recalls in our database
💊 Drugs Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date
💊 Drugs Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Aloe Up Sport Performance Sunscreen Lotion SPF 30, 1 FL OZ (30 mL) per tube, Mfd. for: ALOE UP, 9700 W. 76th St., Ste 112, Eden Prairie, Minnesota 55344
SV Labs Prescott
💊 Drugs Class I - Dangerous
cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing.
CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419
Baxter Healthcare
🏥 Medical Devices Class I - Dangerous
IV sets may leak.
Model Number L211 PROPONENT DR SL MRI Pacemaker
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Model Number S702, ALTRUA 2 DR SL Pacemaker
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
🏥 Medical Devices Class I - Dangerous
IV sets may leak.
Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY ANGIO PACK- 205991 RCAN45C ANGIO CUSTOM RCH UDCO10F CVL CORONARY PACK 219224
American Contract Systems
🏥 Medical Devices Class I - Dangerous
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
GE Medical Systems
🏥 Medical Devices Class I - Dangerous
The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
🏥 Medical Devices Class I - Dangerous
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Model Number U128, VALITUDE CRT-P EL MRI
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
🏥 Medical Devices Class I - Dangerous
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
🏥 Medical Devices Class I - Dangerous
IV sets may leak.