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Showing 3341–3360 of 35916 results

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3M Ranger Irrigation Set (3M) – Flow Rate Clarification (2025)

Notice was issued to clarify flow rates related to the inlet fluid temperature.

FDAApr 22, 2025Nationwide• 3M Company

Clindamycin HCl Capsules (RemedyRePack) - CGMP Issues (2025)

CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.

Class IIModerate

FDAApr 22, 2025FL, PA, VA• RemedyRePack Inc.

Plum Duo Infusion Pump (ICU Medical) – Dose Limit Bypass (2025)

Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.

High

FDAApr 22, 2025Nationwide• ICU Medical, Inc.

Blue Bird Vision Electric (Blue Bird) – Brake Software Issue (2025)

Blue Bird Bus Company (Blue Bird) is recalling certain 2022-2024 Vision electric school buses equipped with hydraulic brakes. The system software may fail to detect and alert the driver to a loss of the secondary brake assist.

NHTSAApr 21, 2025Nationwide• BLUE BIRD

Lower Extremity Implant (American Contract) – EO/ECH Residuals (2025)

Test results for cast padding component included in procedure trays shows Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals exceeded residual limits, which may lead to a possible loss or lack of functionality that may lead to a delay or prolonged treatment/procedure/therapy.

FDAApr 21, 2025Nationwide• American Contract Systems, Inc.

BD Cathena IV Catheter (BD) – Septum Defect Risk (2025)

Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in blood leakage from the septum during insertion, which may cause blood exposure or the need for a second IV to be placed - which may result in therapy delay.

FDAApr 21, 2025Nationwide• Becton Dickinson Infusion Therapy Systems, Inc.

Precision Sampling Set (Capnia) – Contamination Risk (2025)

Sampling set nasal cannula used with End-Tidal Carbon Monoxide (ETCO) monitor may have residual carbon monoxide and volatile organic compounds present due to insufficient aeration of the cannula's carbon filter prior to sealing, which may lead to higher than expected ETOCc scores during clinical evaluations.

FDAApr 21, 2025Nationwide• Capnia Inc

Highland Ridge GO PLAY (Highland Ridge) – Label Inaccuracy (2025)

Highland Ridge RV (Highland Ridge) is recalling certain 2025 Highland Ridge GO Play travel trailers. The certification and tire information labels may have the incorrect Gross Axle Weight Rating (GAWR) and state the incorrect tire and rim size. As such, these vehicles fail to conform to Federal Motor Vehicle Safety Standard (FMVSS) number 110, "Tire Selection and Rims" and the requirements of 49 CFR Part 567, "Certification."

NHTSAApr 21, 2025Nationwide• HIGHLAND RIDGE TT

Motiv F-59 BEV School Bus (Motiv) – Powertrain Bracket (2025)

Motiv Power Systems, Inc. (Motiv) is recalling certain 2020 F-59 school buses equipped with a Motiv Gen 5 EPIC powertrain. A support bracket may fatigue and break, allowing the main power disconnect to contact other structures and short.

NHTSAApr 21, 2025Nationwide• MOTIV

Tirofiban Hydrochloride Injection (Eugia US) - Stability Concern (2025)

Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.

Class IIModerate

FDAApr 21, 2025Nationwide• Eugia US LLC

EVENITY Injection (Mckesson) - Temperature Excursion (2025)

CGMP Deviations; potential temperature excursions due to transit delays

Class IIModerate

FDAApr 21, 2025FL, OH, VA• Mckesson Medical-Surgical Inc. Corporate Office

BENLYSTA Injection (Mckesson) - Temperature Excursion (2025)

CGMP Deviations; potential temperature excursions due to transit delays

Class IIModerate

FDAApr 21, 2025FL, OH, VA• Mckesson Medical-Surgical Inc. Corporate Office

PROLIA Injection (Mckesson) - Temperature Excursion (2025)

CGMP Deviations; potential temperature excursions due to transit delays

Class IIModerate

FDAApr 21, 2025FL, OH, VA• Mckesson Medical-Surgical Inc. Corporate Office

Monkfish Liver (JJWV Marketing) – Undeclared Milk (2025)

Undeclared Allergen

Undeclared allergen ingredient (milk)

FDAApr 21, 2025CA• JJWV Marketing Corporation

Tirofiban Hydrochloride Injection (Eugia US) - Stability Concern (2025)

Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.

Class IIModerate

FDAApr 21, 2025Nationwide• Eugia US LLC

Motiv F-53 BEV Chassis (Motiv) – Support Bracket Risk (2025)

Motiv Power Systems, Inc. (Motiv) is recalling certain 2019-2022 F-53 and F-59 vehicles equipped with a Motiv Gen 5 EPIC powertrain. A support bracket may fatigue and break, allowing the main power disconnect to contact other structures and short.

NHTSAApr 18, 2025Nationwide• MOTIV

Forest River Aurora (Forest River) – Electrical Wiring (2025)

Forest River, Inc. (Forest River) is recalling certain 2024-2025 Forest River Aurora and Coachmen Catalina travel trailers. Please see the 573 report for the complete list of model numbers. The front exterior accent lights, awning, and auto-leveling system may be incorrectly wired and not have proper over current circuit protection.

NHTSAApr 18, 2025Nationwide• FOREST RIVER

East to West Bravado (Forest River) – Slide Room Detachment (2025)

Forest River, Inc. (Forest River) is recalling certain 2025 East to West Bravado BRC33DSF motorhomes. The slide-room floor may detach from the vehicle in the open position. Additionally, the slide-room floor may not properly retain the seat belts during a crash.

NHTSAApr 18, 2025Nationwide• EAST TO WEST

Ford Bronco (Ford) – Control Arm Ball Joint (2025)

Ford Motor Company (Ford) is recalling certain 2025 Bronco vehicles. The front upper control arm ball joint nut may be missing or tightened improperly, allowing the front upper control arm to detach from the knuckle assembly.

NHTSAApr 18, 2025Nationwide• FORD

niCARdipine Hydrochloride Injection (American Regent) - Sterility Risk (2025)

Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.

Class IIModerate

FDAApr 18, 2025Nationwide• American Regent, Inc.

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