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All product recalls affecting Alabama.
Includes nationwide recalls (tagged “Nationwide”) and recalls with Alabama in the distribution area.
Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the finished product.
Use of Tack Endovascular system, designed to treat acute dissections of inner wall or lining of an artery by tacking damaged tissue to inner luminal surface, could result in problems with deployment and stability of device in vessel after deployment, which may cause failure to resolve dissection, migration of implant, bailout stenting, reintervention, unintended removal of tack devices, and ischemia.
Beckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing the correct onboard stability (Open Expiration) dates for assays that were loaded prior to a software upgrade (e.g. 1.3 to 1.4, 1.4 to 1.4.1, etc.). As a result, assays that have expired may still be used for sample processing, leading to inaccurate or erroneous patient test results. The issue only happens on assays loaded before instruments doing upgrades and does not impact new installation. It does not impact the assays loaded after upgrade.
Automated dispensing device labeling is being updated to strengthen labeling around manual access to medications to address the risk of potential delays in retrieving contents/ accessing medications that may result from power loss or potential automated dispensing device malfunctions.
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The issue may lead to ventilation bag malfunction in which the user is unable to inflate/deflate properly during manual ventilation. Potential risks to health include oxygen deprivation, leading to respiratory distress and medical complications.
The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The issue may lead to ventilation bag malfunction in which the user is unable to inflate/deflate properly during manual ventilation. Potential risks to health include oxygen deprivation, leading to respiratory distress and medical complications.
The MSOT Acuity Echo does not include an adequate instruction for safe operation of the device. The previous version of the user manuals contained a wrong value for the Nominal Ocular Hazard Distance (NOHD).
Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.
Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.
Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.
Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong therapy (dose, item, timing, etc.), or 3) unauthorized access and/or compliance related issues
Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation.
Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.
This recall involves SIG SAUER ROMEO5 Red Dot Sights, Models SOR52001 and 7400579, which is a part included with Model SORJ53101. They are labeled with the SIG SAUER logo and ROMEO5 name on one side of the product. The model number can be found on the product packaging. The recalled dot sights contain either the letter K or M as the last digit of the serial number printed on the bottom of the sight. Sig Sauer will provide instructions on how to access the serial number. The optic sights come in the color black and with one packaged CR2032 button cell battery.
This recall involves Wemfg's children's multi-purpose bike helmets. The helmets were sold in size small (S), fitting a head circumference of about 19-1/2 to 21-1/4 inches; and in the following multiple color combinations: blue/pink, green/blue, green/blue/purple, pink/blue/green, pink/purple/pink, pink/yellow/green, purple/pink/blue and purple/pink/yellow. All helmets have black padding, black straps and a black and red buckle. The helmets have a black and red plastic knob at the back of the helmet for adjusting the fitting. The model "MD-710-S" is printed on a white label on the inside of the helmet.
Blue Bird Body Company (Blue Bird) is recalling certain 2024-2025 All American school buses. Due to incorrect wiring, the high and low beams are reversed, causing the high beam indicator to illuminate incorrectly. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 108, "Lamps, Reflective Devices, and Associated Equipment."
Blue Bird Body Company (Blue Bird) is recalling one 2025 All American transit bus. Due to incorrect wiring, the high and low beams are reversed, causing the high beam indicator to illuminate incorrectly. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 108, "Lamps, Reflective Devices, and Associated Equipment."
Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.