Latest Product Recalls Today

Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.

There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.

Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.

Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.

Due to a software issue within the WebApp that potentially prevents the user to overwrite the results.

This recall is retroactively being reported. Refurbished bassinets failed to meet quality standards prior to distribution.

Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.

If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.

Potential for breach in sterile barrier of device packaging.

Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.

Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.

Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange.

Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange.

Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."

Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity. As a result, data from a previous patient may remain on the screen and could be incorrectly associated with a subsequent patient.

Devices could potentially contain an occluded or partially occluded Guedel Airway tip.

Due to a defective circuit board that overheats

Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results; Increased rate of reaction cuvette QC failures and Delayed results due to QC failures.

Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.

out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated.

Marion Body Works Inc. (Marion Body Works) is recalling certain 2025 Pumper fire engines, equipped with certain Weldon UV800 Display Unit user interfaces. The display may stop responding to touch commands or fail to power on, preventing the activation of exterior emergency lights, fire fighting and other emergency equipment. A loss of exterior lights can reduce the visibility of the vehicle to other drivers, increasing the risk of a crash. Inoperative equipment can delay emergency response, increasing the risk of injury.

Daimler Trucks North America, LLC (DTNA) is recalling certain 2024-2027 Thomas Built Buses Saf-T-Liner C2 transit buses. The fuel tank cage material and fuel system mounting may be incompatible. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 301, "Fuel System Integrity." During a crash, an incompatible fuel tank cage and fuel system may result in a fuel leak, increasing the risk of a fire.