💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
All Recalls
95,114 total recalls in our database
B-Lipo, 30 Capsules, Manufactured by KM DALI, Kunming, China for Bethel Nutritional Consulting, Inc.599 West 190th Street, Suite #1 NYC, NY 10040.
Bethel Nutritional Consulting
💊 Drugs Class I - Dangerous
Marketed without an Approved NDA/ANDA; found to contain Lorcaserin, a controlled substance used for weight loss
🏥 Medical Devices Class I - Dangerous
If the patient sits on either wing, not squarely on the center section of the Stretcher Lift, tipping and injury to the operator or patient could result. The device manual was updated with an additional warning statement.
GE Healthcare has become aware of a potential safety issue involving MRI systems due to software versions not being maintained properly at some sites.
Devices were not sterilized
Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425
Advanced Sterilization Products
🏥 Medical Devices Class I - Dangerous
Advanced Sterilization Products (ASP) is recalling the Tyvek Rolls with STERRAD Chemical Indicator because they were shipped to customers after its expiration date of May 18, 2013.
🏥 Medical Devices Class I - Dangerous
One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed.
🏥 Medical Devices Class I - Dangerous
Becton Dickinson received an elevated number of complaints for blood or infusate/medication leakage due to tearing of the silicone septum.
Incorrect calibrator lot values were assigned for ADVIA Chemistry Systems Drug Calibrator I, lot 3JD018, for the ADVIA Chemistry Systems Phenytoin 2 (PHNY_2) and Phenobarbital 2 (PHNB_2) assays which was the result of calibrator value miscalculation.
The gradient output supervision was permanently turned off on the MAGNETOM system, meaning that gradient outputs could exceed IEC60601-2-33 limits and peripheral nerve stimulation could occur.
🏥 Medical Devices Class I - Dangerous
Locking pegs were not locking during distal radius procedures. There has been one (1) report of revision surgery scheduled to remove a loosened peg.
🏥 Medical Devices Class I - Dangerous
The TCS Straight Hexlobular #6 Drivers (5210-1004) tip sheared off during use in procedures that involved patients with dense bones. As a result of this malfunction, Titan Spine, LLC is removing all of the TCS Straight Hex lobular #6 Drivers (5210-1004) Lot# G150101 from the field.
🏥 Medical Devices Class I - Dangerous
The OAD saline sheath outer layer may flake off from the catheter due to friction between the outer material layer and corresponding materials it may come in contact with during clinical use. If the material is large enough, it has the potential to cause a flow limiting embolism.
In May 2013, the original recall was initiated due to complaints the Hand Switch for the Electric Pen Drive was not labeled correctly, and the on and lock labels were interchanged.
Alaris PC units, Model No. 8015. Infusion pump.
CareFusion 303
🏥 Medical Devices Class I - Dangerous
CareFusion is recalling the Alaris PC unit because of an error code. The error code may occur upon power on during the "Power-On Self Test" due to a keypad issue.
Correction due to a fault that causes distal SUJ (DSUJ) failures that indicates a mismatch between the positions reported by the redundant position sensors on one of the patient cart arm joints.
🏥 Medical Devices Class I - Dangerous
Devices were not sterilized
🏥 Medical Devices Class I - Dangerous
VCG battery ignited in a VCG unit when recharging.
🏥 Medical Devices Class I - Dangerous
An issue with photon dose calculation for DMLC (Dynamic MLC) plans for machines where the MLC is positioned above the jaws, e.g. some Elekta linacs. The magnitude of the error depends on the beam model output factor corrections and on the individual DMLC plan characteristics.
🏥 Medical Devices Class I - Dangerous
The firm is recalling Rheo Knee bionic prosthetic due to it being discovered during an internal audit of the service line that devices were released for distribution without fully going through the assembly process.