Aztreonam 1 gram in normal saline
Walgreens Infusion Services
Lack of sterility assurance.
95,114 total recalls in our database
Walgreens Infusion Services
Lack of sterility assurance.
the Instructions for Use (IFU) were inadvertently removed from the kit.
The tunneling sheath packaged within the kits can crack during placement. If the tunneling sheath cracks, it can cause a delay in treatment for the time it takes to retrieve a replacement kit.
One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left at a hospital and was not sterilized.
Customer notification that the device may be difficult to open or close.
Philips Medical Systems
Philips has discovered that the Instructions for Use (IFU) for the IntelliVue TcG10 Transcutaneous Gas Measurement Module is missing the contraindication that the device is not to be used on patients under gas anesthesia.
Potential for composed images to be flipped before being sent to PACS on systems with software version VE10 and SmartOrtho license. Flipped images may be reversed so the associated annotations, e.g. labels (R/L), may be displayed incorrectly, potentially leading to misdiagnosis.
Some Lots of PF4 Concentrated Wash (10X) are a slightly more dilute concentration. This may lead to slightly increased Optical Density (OD) values. Samples with a higher background reactivity may demonstrate false positive result (borderline reactivity) at or near the cutoff for the assay.
Ferno-Washington
The wheel castor assemblies may be loosening on the stretchers.
TransMotion Medical
The firm is finding that the stretcher chair controllers are moving the chairs involuntarily.
cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS Calibrator.
Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Products Calibrator Kit 2.
The wrong movement results on the MAGNUS OR table. The button commands on the TEGRIS touchscreen for Lower Leg Up and Upper Leg Down are switched in the software for the integration with the MAGNUS operating table system.
BD Biosciences, Systems & Reagents
One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and incorrect patient data.
BD Biosciences, Systems & Reagents
Two lots of the Anti-Lambda APC-H7 antibody are contaminated with CD38 antibody.
Reports of customers falling from the Inversion Table and sustaining injuries. The Inversion Table is a fitness product, not a medical device. DSG removed medical claims from product labels and advertising.
Unknown Manufacturer
The plastic menorah can catch fire if candles are allowed to burn to the base of the menorah.
Unknown Manufacturer
The sander can short circuit, posing a fire hazard.
Primal Vantage Co., of Bernardsville, N.J.
The cast aluminum platform can break, causing the user to fall to the ground and suffer serious injuries.
JHTNA Manufacturing LLC, of Milwaukee, Wis.
The handle attachment on the strength training machines can detach during use and hit the user with force and/or cause the user to lose balance and fall. This poses a risk of impact injury, laceration and fall hazards.