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Showing 3861–3880 of 4978 results

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Levothyroxine 88mcg (ACCORD) – Subpotent (2025)

Subpotent

Class IIModerate

FDAApr 10, 2025Nationwide• ACCORD HEALTHCARE, INC.

Levothyroxine Sodium Tablets (Accord Healthcare) – Subpotent Medication (2025)

Subpotent

Class IIModerate

FDAApr 10, 2025Nationwide• ACCORD HEALTHCARE, INC.

Cadillac Lyriq (Cadillac) – Stabilizer Bar Bolt (2025)

General Motors LLC (GM) is recalling certain 2023-2025 Cadillac LYRIQ vehicles. The left or right front stabilizer bar bracket bolts may have been improperly tightened, which can allow the bolts to loosen and separate from the vehicle frame. A detached stabilizer bar or bracket can damage the vehicle's high voltage cables or EV battery coolant lines.

Moderate

NHTSAApr 10, 2025Nationwide• CADILLAC

Tequila Lime Base (Bakkavor Foods) – wood pieces (2025)

Foreign Object - Wood. The firm was notified by their supplier that the product may contain pieces of wood.

Class IIModerate

FDAApr 10, 2025AL, CA, FL +1 more• Bakkavor Foods USA, Inc.

CADD Solis Pump (Smiths Medical) – Wireless Connection (2025)

Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.

Very High

FDAApr 10, 2025Nationwide• Smiths Medical ASD, Inc.

CADD-Solis Infusion Pump (Smiths Medical) – Thermal Damage (2025)

There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.

Moderate

FDAApr 10, 2025Nationwide• Smiths Medical ASD, Inc.

CADD-Solis HPCA Pump (Smiths Medical) – Occlusion Alarm (2025)

Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.

Very High

FDAApr 10, 2025Nationwide• Smiths Medical ASD, Inc.

CMS8000 Patient Monitor (Contec) – Cybersecurity Risk (2025)

Patient monitor has nine identified cybersecurity vulnerabilities.

Moderate

FDAApr 10, 2025Nationwide• Contec Medical Systems Co., Ltd. Economic And No.

Chicco MyFit Child Seat (Chicco) – Seat Safety (2025)

Chicco USA, Inc. (Chicco) is recalling certain MyFit Zip Air Harness and Booster child restraint seats (CRS) with model numbers 07079561970070 and 04079561190070. In certain configurations, the child seat may allow excessive chest movement in a crash. As such, these child seats fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 213, "Child Restraint Systems."

Moderate

NHTSAApr 9, 2025Nationwide• CHICCO

Waltco Slide Liftgate (Waltco) – Liftgate Support (2025)

Hiab USA Inc. (Hiab) is recalling certain Waltco ZS-MK2 series lift gates, with model numbers ZS-MK2-STD 2000-155 12V and ZS-MK2-SLI 2000-155 12V. The cylinder pin in the slide liftgate may be insufficiently lubricated, which can cause the pin to seize, resulting in lift gate failure.

Moderate

NHTSAApr 9, 2025Nationwide• WALTCO

Audi Q6 E-Tron (Audi) – Rearview Camera Blur (2025)

Volkswagen Group of America, Inc. (Audi) is recalling certain 2025 SQ6 e-tron and Q6 e-tron vehicles. The rearview camera may show a blurry image. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 111, "Rear Visibility."

Moderate

NHTSAApr 9, 2025Nationwide• AUDI

FoundationOne Diagnostic (Foundation Medicine) – Variant Reporting (2025)

Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx claim. The remaining three (3) with tumor profiling result changes did not impact CDx indications.

Moderate

FDAApr 9, 2025Nationwide• Foundation Medicine, Inc.

Audi SQ6 Sportback E-Tron (Audi) – Camera Software (2025)

Volkswagen Group of America, Inc. (Audi) is recalling certain 2025 SQ6 and Q6 vehicles. The rearview camera image may be delayed or deactivated after shifting into reverse. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 111, "Rear Visibility."

Moderate

NHTSAApr 9, 2025Nationwide• AUDI

Alliance RV Avenue (Alliance RV) – Label Inaccuracy (2025)

Alliance RV, LLC (Alliance) is recalling certain 2025 Avenue 23ML travel trailers. The Federal Placard may have the incorrect Unloaded Vehicle Weight (UVW) and Cargo Carrying Capacity (CCC) information, allowing the trailer to be overloaded.

Moderate

NHTSAApr 9, 2025Nationwide• ALLIANCE RV

Centurion Weitlaner Retractor (Medline) – Packaging Integrity (2025)

Three is the potential for the retractors to puncture through the sterile packaging.

Low

FDAApr 9, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

Hemopropin Ointment (Apipharma) – CGMP Deviations (2025)

CGMP Deviations

Class IIModerate

FDAApr 9, 2025AZ• Apipharma

Wegovy (Cardinal Health) – Temperature Storage Abuse (2025)

Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated storage for an extended period of time and inappropriately released.

Class IIModerate

FDAApr 9, 2025NC, SC, VA• Cardinal Health Inc.

Kapsin Ointment (Apipharma) – CGMP Deviations (2025)

CGMP Deviations

Class IIModerate

FDAApr 9, 2025AZ• Apipharma

McLaren Artura (McLaren) – Brake Line Routing (2025)

McLaren Automotive Incorporated (McClaren) is recalling certain 2020-2025 600LT, 720S, Artura, GT, and GTS vehicles. The brake lines may be routed incorrectly and cause the brakes on the incorrect side to activate, possibly resulting in one of the rear wheels locking up.

Moderate

NHTSAApr 9, 2025Nationwide• MCLAREN

PiezoWave 2 Control Unit (Richard Wolf) – Capacitor Failure (2025)

Fire/Burn Risk

The high voltage capacitor may fail early in the product life cycle after delivery of surge voltages. When this failure occurs, the capacitor may produce smoke and a burning smell. In extremely rare instances a capacitor may cause a spark or excessive heat when an internal capacitor failure occurs.

High

FDAApr 9, 2025GA• Richard Wolf GmbH Pforzheimer Str. 32 Knittlingen Germany

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