💊 Drugs Class I - Dangerous
Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
All Recalls
95,018 total recalls in our database
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
💊 Drugs Class I - Dangerous
Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
🏥 Medical Devices Class I - Dangerous
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167
Medline Industries
🏥 Medical Devices Class I - Dangerous
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
Complaints of the ceramic tip of the resection sheath breaking have been received.
🏥 Medical Devices Class I - Dangerous
Knee and Humeral socket implants contain incorrect labeling.
Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applications.
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
Complaints of the ceramic tip of the resection sheath breaking have been received.
🏥 Medical Devices Class I - Dangerous
Due to battery component overheating while charging resulting in melting of internal components and causing smoke.
Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
Complaints of the ceramic tip of the resection sheath breaking have been received.
🏥 Medical Devices Class I - Dangerous
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
Complaints of the ceramic tip of the resection sheath breaking have been received.
Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
Complaints of the ceramic tip of the resection sheath breaking have been received.
Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
Complaints of the ceramic tip of the resection sheath breaking have been received.
Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications.
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
Complaints of the ceramic tip of the resection sheath breaking have been received.
Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications.
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
Complaints of the ceramic tip of the resection sheath breaking have been received.
Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
Medtronic Perfusion Systems
🏥 Medical Devices Class I - Dangerous
During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic applications.
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
Complaints of the ceramic tip of the resection sheath breaking have been received.
Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528
Medline Industries
🏥 Medical Devices Class I - Dangerous
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.