💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
All Recalls
92,900 total recalls in our database
💊 Drugs Class I - Dangerous
Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.
💊 Drugs Class I - Dangerous
Failed Impurity/Degradation Specifications
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Pitavastatin Tablets, 2 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 63247, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054, Product of Taiwan, NDC 0480-3632-98.
Orient Pharma Co., Ltd. Yunlin Plant
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications.
ZICAM NASAL ALLCLEAR, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc.., Ewing NJ. UPC 7 32216 30165 6
Church & Dwight
💊 Drugs Class I - Dangerous
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
💊 Drugs Class I - Dangerous
Defective container; blister packaging inadequately sealed.
Philips eL18-4 EMT Transducer.
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
Ultrasound transducer devices were refurbished beyond their useful life.
REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation.
Becton, Dickinson and Company, BD Bio Sciences
🏥 Medical Devices Class I - Dangerous
Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples.
Philips C9-5EC Transducer.
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
Ultrasound transducer devices were refurbished beyond their useful life.
Change Healthcare Cardiology Hemodynamics Software
CHANGE HEALTHCARE CANADA COMPANY
🏥 Medical Devices Class I - Dangerous
Due to complaints, software update may cause software to unexpectedly shutdown.
Servo-u Ventilator System. Model Number: 6688600.
Maquet Critical Care AB
🏥 Medical Devices Class I - Dangerous
Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.
🏥 Medical Devices Class I - Dangerous
Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches.
Philips eL18-4 Transducer.
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
Ultrasound transducer devices were refurbished beyond their useful life.
🏥 Medical Devices Class I - Dangerous
Cather packaging may contain the incorrect French size.
BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sold OUS
Philips Respironics
🏥 Medical Devices Class I - Dangerous
This device does not indicate for use in patients with respiratory failure.
Philips C5-2 Transducer.
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
Ultrasound transducer devices were refurbished beyond their useful life.
Philips L12-3 Transducer.
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
Ultrasound transducer devices were refurbished beyond their useful life.
Philips X6-1 Transducer.
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
Ultrasound transducer devices were refurbished beyond their useful life.
🏥 Medical Devices Class I - Dangerous
Glucose microcuvettes experienced transit time outside of limits, so stability through the whole microcuvette lifetime can no longer be guaranteed. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency, and purity of the product. This failure could increase the probability of an incorrect test result or a delayed test result.