United States Recalls
Consumer recalls from the FDA, CPSC, NHTSA, and USDA FSIS.
Automated Impella Controller (AIC); Product Code: 0042-0000-US;
A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented through Abiomed s servicing process; therefore, AICs that have not received service are pending these updates. Issue 1: The proximity of the internal Video Graphics Array cable to the Digital Signal Processor chipset on the Impellatronic printed circuit assembly could potentially result in Electrostatic Discharge coupling into the Digital Signal Processor which may interrupt motor controls. Issue 2: There is a potential for the Compact Flash Memory Card dislodgement due to external applied forces, which could result in AIC startup failures and data logging issues. Issue 3: Improper routing of the fan wire within the AIC could lead to fan wire damage, which may result in console boot-up failure. Issue 4: Potential capacitor related issues on the Power Battery Manager, including the potential for the capacitors to cause pump stop, purge stop, and/or single fan fuse failures.
Automated Impella Controller (AIC) with the below product descriptions and corre...
Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2. There is improper alignment between the purge cassette and the motor drive in the AIC. This can result in a piston block event and lead to the inability to complete priming of the purge system, requiring the user to switch to backup AIC console.
GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Pro...
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, la...
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
Wawa Diet Lemonade Pint (16oz), Plastic bottle
Undeclared Milk Allergen,
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, la...
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, la...
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; u...
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, ...
It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data. In some cases, a system restart may temporarily restore functionality.
Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimul...
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product...
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003...
It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data. In some cases, a system restart may temporarily restore functionality.
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, la...
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
Wawa Iced Tea Lemon 16 oz Pint, Plastic bottle
Undeclared Milk Allergen,
Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed...
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Steril...
Failed Stability Specifications
Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ2162...
Specific Medline Kits contain Cardinal Health Monoject 1mL Luer Lock Syringes, Tuberculin Print, Sterile. Cardinal Health has recalled these syringes because the outer carton and blister pack are labeled as a 1 mL Luer Lock Tuberculin Syringe (Product Code 1180100777), but the syringes inside are U-100 insulin syringes.
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, la...
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
Braun Corporation - Air Bags May Not Deploy
The unintended connection may prevent the air bags from deploying, increasing the risk of injury during a crash.
Braun Corporation - Wheelchair Seat Belts May Not Properly Restrain Occupants
Improperly restrained occupants have an increased risk of injury during a crash.
Nova Bus (US) Inc. - Low Brake Air Pressure Warning Light May Not Illuminate/FMV...
A low brake air pressure warning light that fails to illuminate when the engine is off will not alert the driver to a low brake pressure condition, increasing the risk of a crash if the parking brake is disengaged before starting the engine.
Kia America, Inc. - Driver Seat Belt Strap May Not Extend/FMVSS 209
A seat belt strap that does not extend can fail to restrain an occupant in a crash, increasing the risk of injury.
Grand Design RV, LLC - Incorrectly Tightened Shock Bolts
Broken shock retainer bolt heads and washers may detach and become a road hazard, increasing the risk of a crash.
Synear Foods USA, LLC Recalls Frozen Pork and Crab Soup Dumpling Products Due to...
Misbranding, Unreported Allergens