ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
Ethicon Endo-Surgery
🏥 Medical Devices Class I - Dangerous
The devices were shipped unsterilized.
All Recalls
95,075 total recalls in our database
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180
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 L101, ESSENTIO 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
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.
Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 205972 IHCY10Y CYSTO PACK MHCY35AE CYSTO PACK- 212487 PLBY52E CYSTO PACK UDCY31Z CYSTO PACK - 206047 UICY28L MOR CYSTO PACK
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.
🏥 Medical Devices Class I - Dangerous
IV sets may leak.
BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100
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.
Cardiac Workstation 5000; Model Number: 860439;
Philips North America
🏥 Medical Devices Class I - Dangerous
Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
🏥 Medical Devices Class I - Dangerous
IV sets may leak.
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC
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 L209 PROPONENT DR (VDD) 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).
BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170
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 convenience kits Item number/ Product description AHLD15X LABOR DELIVERY PACK - 213387 AKDV96B VAGINAL DELIVERY AKDV96B VAGINAL DELIVERY EVBH28D BIRTHING ROOM PACK UPVD01K VAGINAL DELIVERY PACK
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.
Model Number U226, VISIONIST CRT-P EL
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 PE2
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
IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't use in neonates/infants, with target tidal volumes less-than50mL or less-than10kg- at high risk of cardiopulmonary/neurological compromise due to unrecognized hypoventilation, updates for continued use in others before design update; leak may cause respiratory acidosis, hypoxemia, or respiratory failure.
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190
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.
Product: STA Liatest D-Di; REF: 00515;
Diagnostica Stago
🏥 Medical Devices Class I - Dangerous
A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.