💊 Drugs Class I - Dangerous
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
All Recalls
95,018 total recalls in our database
Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of therapy and exposure to caustic substances. Ports available as standalone connectors, or utilized as access points on vial adaptors, bag spikes, and administration sets.
Various Angiography packs/trays
American Contract Systems
🏥 Medical Devices Class I - Dangerous
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Breast Abdominoplasty Pack
American Contract Systems
🏥 Medical Devices Class I - Dangerous
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Various C-section packs
American Contract Systems
🏥 Medical Devices Class I - Dangerous
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Various convenience packs
American Contract Systems
🏥 Medical Devices Class I - Dangerous
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS
Stradis Healthcare
🏥 Medical Devices Class I - Dangerous
Potential for incomplete seals.
Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
Philips Respironics
🏥 Medical Devices Class I - Dangerous
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
🏥 Medical Devices Class I - Dangerous
Certain lots containing undersized dilator.
🏥 Medical Devices Class I - Dangerous
Bleed monitoring system device design error, causing the device to not power on and complete the series of self-tests so instructions for use being updated to include device check before use ensure that the device is functioning appropriately.
Various convenience packs
American Contract Systems
🏥 Medical Devices Class I - Dangerous
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
D&C pack
American Contract Systems
🏥 Medical Devices Class I - Dangerous
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Philips BiPAP V30 Auto, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
Philips Respironics
🏥 Medical Devices Class I - Dangerous
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
Various Port Insertion Packs
American Contract Systems
🏥 Medical Devices Class I - Dangerous
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Various ob/gyn packs
American Contract Systems
🏥 Medical Devices Class I - Dangerous
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
🏥 Medical Devices Class I - Dangerous
Certain lots containing undersized dilator.
Various eye packs, cataract packs
American Contract Systems
🏥 Medical Devices Class I - Dangerous
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
🏥 Medical Devices Class I - Dangerous
Excessive ultraviolet-C radiation
VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461
Ortho-Clinical Diagnostics
🏥 Medical Devices Class I - Dangerous
Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.
Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of therapy and exposure to caustic substances. Ports available as standalone connectors, or utilized as access points on vial adaptors, bag spikes, and administration sets.