💊 Drugs Class I - Dangerous
Lack of assurance of sterility: Product bags leaking at seam.
All Recalls
95,083 total recalls in our database
💊 Drugs Class I - Dangerous
Lack of assurance of sterility: Product bags leaking at seam.
💊 Drugs Class I - Dangerous
Lack of assurance of sterility: Product bags leaking at seam.
💊 Drugs Class I - Dangerous
Lack of assurance of sterility: Product bags leaking at seam.
💊 Drugs Class I - Dangerous
Subpotent Drug; Clavulanic Acid
💊 Drugs Class I - Dangerous
Lack of assurance of sterility: Product bags leaking at seam.
💊 Drugs Class I - Dangerous
Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets
💊 Drugs Class I - Dangerous
Lack of assurance of sterility: Product bags leaking at seam.
NMT Patient Cable (989803174581) in use with lntelliVue NMT Module (Part# 865383)
Philips Electronics North America
🏥 Medical Devices Class I - Dangerous
Manufacturing defect may cause localized heating, which may result in localized skin burn.
The firm initiates a voluntary removal and discontinue marketing of Slide-Loc Anatomic Radial Head System based on its performance in the market. The firm received product complaints regarding instrumentation performance, trial product design, and implant dissociations.
🏥 Medical Devices Class I - Dangerous
Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
🏥 Medical Devices Class I - Dangerous
Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
Incorrect expiration date on label. Correct expiration date was March 25, 2019. Product was labeled with expiration date of March 28,2019.
Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on a range of clinical chemistry systems.
Randox Laboratories
🏥 Medical Devices Class I - Dangerous
According to Randox Laboratories an investigation indicates a labelling error for 2 of the test methods listed for quantification of Total Protein (urine). The values for the mean of all instruments are incorrect by a factor of 10. Instrument specific values are correct. This does not affect the performance or stability claims of the product. As control results will be outside of the quoted range this may result in a delay in reporting the sample test results. However as the correct instrument specific means are also included in the value sheet this delay is unlikely. Customers have been referred to their Medical Director for further advice
🏥 Medical Devices Class I - Dangerous
During patient interventions with the urology table the radiation is activated with a footswitch connected to the table. This footswitch is actively involved in the safety circuit of the urological table. Only if footswitch + exposure + first primary barrier are closed the signal will be transmitted to the generator for activating X-ray. During intended use only with this footswitch X-ray should be activated.
Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 Product Usage: Used for the isolation of fungi from surfaces sanitized with quaternary ammonium compounds
Acumedia Manufacturers
🏥 Medical Devices Class I - Dangerous
Storage temperature listed on the label was incorrect. Label stated 2-30¿C. Actual storage temperature is 2-8¿C.
The manufacturer of the DOLPHIN inflation device, Perouse Medical, has initiated a recall of the device due to a potential defect in the sterile barrier. Use of affected product could pose a risk of microbial contamination, leading to infection.
🏥 Medical Devices Class I - Dangerous
PEG kits have the potential for one of the following defects: missing components, duplicate components or missing label/Instructions for Use, which includes expiry information.
🏥 Medical Devices Class I - Dangerous
Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
🏥 Medical Devices Class I - Dangerous
Exact Sciences is correcting all Sample Mixer v2 Upgrade units because of incidents of Sample Mixer door damage, which has occurred when the Sample Holder opens during a run and the Sample Holder lid makes contact with the Sample Mixer door.