All Recalls

95,025 total recalls in our database

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.

Feb 4, 2021 Infusion Pumps Nationwide View Details →

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

Mar 3, 2021 Other Medical Devices Nationwide View Details →

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

Feb 11, 2021 Other Medical Devices View Details →
🏥 Medical Devices Class I - Dangerous

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

Feb 22, 2021 Infusion Pumps View Details →

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.

Jan 20, 2021 Diagnostic Equipment View Details →

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.

Jan 19, 2021 Surgical Instruments View Details →

System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.

Dec 8, 2020 Diagnostic Equipment Nationwide View Details →

System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.

Dec 8, 2020 Diagnostic Equipment Nationwide View Details →

System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.

Dec 8, 2020 Diagnostic Equipment Nationwide View Details →

Beal Birdie Belay Devices

Beal Sas, of France

🏠 Consumer Products Class II - Moderate

The device user can be unable to lower the climber, posing a risk of injury to the climber.

Mar 24, 2021 Other Consumer Products Nationwide View Details →
🏠 Consumer Products Class I - Dangerous

The propane cylinders manufactured with a handle below the weld on the side could leak propane gas, posing a fire hazard.

Mar 24, 2021 Other Consumer Products Nationwide View Details →

Evrysdi™ (risdiplam)

Genentech, a member of the Roche Group, of South San Francisco, Calif.

🏠 Consumer Products Class II - Moderate

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).

Mar 18, 2021 Children's Products Nationwide View Details →