💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
All Recalls
95,064 total recalls in our database
💊 Drugs Class I - Dangerous
Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.
💊 Drugs Class I - Dangerous
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
💊 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
Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber.
💊 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.
💊 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.