Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
All Recalls
95,025 total recalls in our database
SOMATOM systems-issues in with software syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a, may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications. Delay in diagnosis or patient rescan may occur. Sporadic software errors during interventional workflows may also result
Defect in the mechanical assembly of the needle holder contained in the navigation kit. One of the 2 jaws of the needle holder does not provide gripping functionality; if the defect is not detected before use, it can cause poor needle guidance and a lack of precision during navigation causing an inaccurate needle position which could cause damage to organs or vasculature adjacent to the trajectory
Incisive CT Computed Tomography X-ray System Model: 728143
Philips North America
Actuators in the Incisive gantry could result in the gantry failure to self-lock if both of the 2 sides actuators fail. In some cases in systems with affected components, the gantry may tilt forward slowly, in a worst case, reaching to the tilt limit angle +31degrees
R&D Systems, Inc. received two complaints that the standard signal was low and controls were not within the specification range provided with the kit. Investigation confirmed low standard signal and controls running out of specification for kits returned from the customer and the retained kits.
The labeled needle tip curvature of specific lots of transseptal needles may not match the actual needle tip curvature. In the event that the incorrect needle is unknowingly used, an unintended anatomy puncture may occur, which is likely to require medical intervention.
System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.
System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.
System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.
Distal tip may become separated from the lumen wire in specific lots.
Beal Birdie Belay Devices
Beal Sas, of France
The device user can be unable to lower the climber, posing a risk of injury to the climber.
Hog 100-pound Propane Cylinders
Unknown Manufacturer
The propane cylinders manufactured with a handle below the weld on the side could leak propane gas, posing a fire hazard.
YTL Log Splitters with Briggs & Stratton 250cc engines
Briggs & Stratton, of Wauwatosa, Wis. (engine)
An incorrect engine ignition coil and flywheel can lead to hard starting and engine kick back, posing an injury hazard to the operator.
Evrysdi™ (risdiplam)
Genentech, a member of the Roche Group, of South San Francisco, Calif.
The bottles containing the prescription drug can leak due to a fit issue between the press-in bottle adapter and bottleneck. If the bottle is leaking, there is a risk of drug exposure by contact with skin or eyes. Prescription drugs must be in child resistant packaging that prevents children from gaining access to the contents as required by the Poison Prevention Packaging Act (PPPA).
illu-Mist Battery-Powered Garden Sprayers
Unknown Manufacturer
The sprayer's lithium-ion battery can overheat, posing a fire hazard.
Shepherd Boy Plush toys with wire staff
Unknown Manufacturer
The metal wire in the shepherd's staff can become exposed, posing a laceration hazard.
YUM CRUMBS, STRAWBERRY SHORTCAKE, 12 oz and 32 oz
THE SAPPHIRE EXCHANGE
Undeclared Red #40
One Degree Organic Foods Gluten Free Sprouted Rolled Oats NET WT. 5 lbs (80 oz) 2.27 kg UPC:6 75625 32318 8
One Degree Organic Foods Inc,
Rancidity and packaging integrity defects in GF sprouted rolled oats
Al-Riyan Tuna Meat in Vegetable oil 7 oz. can 48 cans per case
GREEN CITY DISTRIBUTION
High levels of histamines
Product may contain undeclared almonds.