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Showing 4321–4340 of 4465 results

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Atomoxetine 100mg Capsules (Glenmark) – Impurity Excess (2025)

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Class IIModerate

FDAJan 29, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Madras Curry Powder (Trong Food) – Lead Contamination (2025)

Elevated levels of lead 5.48mg/kg and 2.59mg/kg in (2) lots of Madras Curry Powder.

Class IIModerate

FDAJan 28, 2025IN, MD, WA +1 more• Trong Food International

SinuCleanse Saline Packets (Ascent) – Bacterial Contamination (2025)

Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus

Class IHigh

FDAJan 28, 2025Nationwide• Ascent Consumer Products Inc.

SinuCleanse Neti Pot (Ascent) – Bacterial Contamination (2025)

Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus

FDAJan 28, 2025Nationwide• Ascent Consumer Products Inc.

SinuCleanse Soft Tip Bottle (Ascent) – Bacterial Contamination (2025)

Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus

FDAJan 28, 2025Nationwide• Ascent Consumer Products Inc.

Autocar Legend (Autocar) – shock absorber fasteners (2025)

Autocar, LLC (Autocar) is recalling certain 2020-2026 Autocar DC (Legend) trucks. The cab shock absorber bracket fasteners may have been improperly secured, allowing the fasteners to detach.

NHTSAJan 28, 2025Nationwide• AUTOCAR

Definium/Discovery XR656HD (GE) – exposure limit (2025)

The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.

FDAJan 28, 2025Nationwide• GE Medical Systems, LLC

FCCC XCM (FCCC) – fuel system hose problem (2025)

Daimler Trucks North America LLC (DTNA) is recalling certain 2022-2024 Freightliner Custom Chassis XCM, 2022-2025 Custom Chassis XCR, 2024 Custom Chassis XBS, and 2024-2025 Custom Chassis XCS chassis, equipped with certain Cummins L9 diesel engines. The remote fuel filter hoses may separate from the fitting, causing a fuel leak and an engine stall.

NHTSAJan 28, 2025Nationwide• FCCC

Optima XR646 HD X-Ray System (GE) – exposure limit (2025)

The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.

FDAJan 28, 2025Nationwide• GE Medical Systems, LLC

Mitsubishi Fuso Rizon (Mitsubishi) – wiring seal issue (2025)

Mitsubishi Fuso Truck of America, Inc. (MFTA) is recalling certain 2024 FEC7K and FEC9K trucks. The chassis harness may have been improperly sealed. Water intrusion can shut down the EV system, causing a loss of drive power.

NHTSAJan 28, 2025Nationwide• MITSUBISHI FUSO

Discovery XR656HD X-Ray System (GE) – exposure limit (2025)

The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.

FDAJan 28, 2025Nationwide• GE Medical Systems, LLC

Discovery XR656 HD X-Ray System (GE) – exposure limit (2025)

The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.

FDAJan 28, 2025Nationwide• GE Medical Systems, LLC

Dexcom G6 Monitoring System (Dexcom) – alert failure (2025)

Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different conditions. First, if a receiver operating system .net error occurs when an alarm/alert should be triggered, the initial alarm/alert will not be delivered until a subsequent alarm/alert is triggered. At that time, the initial alarm/alert is delivered, but not the second one. Alarm/alerts will continue to be delayed and be one alarm/alert behind, causing delayed alarm/alerts until the receiver is reset. This condition could result in the missed detection of a hyperglycemic or hypoglycemic event. Second, a single EGV reading may be delayed for 5 minutes after the initial .net operating system error. If the user receives a single EGV reading delayed by 5 minutes, the delay is not expected to cause user harm.

FDAJan 27, 2025Nationwide• Dexcom, Inc.

Prelude IDEAL Sheath Introducer (Merit) – incorrect dilator (2025)

Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.

FDAJan 27, 2025Nationwide• Merit Medical Systems, Inc.

ET Rigid Abutment (Hiossen) – mislabeled packaging (2025)

Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the ET Multi Abutments as Mini version whereas the actual product is a Regular version

FDAJan 27, 2025Nationwide• Hiossen Inc.

Tissue Approximation System (TAS) – strap breakage (2025)

Tissue approximation straps (zip-ties) have broken before or during implantation so firm developed an interim zip-tie conditioning method submerging zip-ties in 104-degrees F sterile saline solution for 60 min prior to implantation to rehydrate the zip-tie straps. Broken zip-ties not observed during procedure could lead to future hernia recurrence, recurrent surgery to correct a large herniation.

FDAJan 27, 2025Nationwide• TAS Medical Inc

Osstem Implant Abutment (Hiossen) – mislabeled packaging (2025)

Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the ET Multi Abutments as Mini version whereas the actual product is a Regular version

FDAJan 27, 2025Nationwide• Hiossen Inc.

Shatavari Powder (Zaarah Herbals) – Lead Contamination (2025)

Product contains elevated levels of lead - 6.50 mg/kg (ppm)

FDAJan 27, 2025CA, CT, NJ +1 more• NEW YORK WHOLESALE GROUP

HydrALAZINE 25mg Tablets (SKY) – Specification Failure (2025)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAJan 24, 2025Nationwide• SKY PACKAGING

HydrALAZINE 50mg Tablets (SKY) – Specification Failure (2025)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAJan 24, 2025Nationwide• SKY PACKAGING

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