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Showing 3121–3140 of 92420 results

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Super Cereal Plus (East Africa Boutique) – Insanitary Conditions (2025)

Products held under insanitary conditions

Class IIModerate

FDAMay 27, 2025IN, KY, MO +1 more• East Africa Boutique, LLC.

Truffle Assortment (Kilwin's) – Undeclared Pecans (2025)

Undeclared Allergen

undeclared pecans

FDAMay 27, 2025AL, DE, FL +11 more• Kilwin's Quality Confections, Inc.

Micro DOT Blister Helmet (Micro DOT) – Penetration Protection Issue (2025)

Micro DOT Helmet Co. (Micro DOT) is recalling certain Blister and Twister original helmets, sizes XXS - XXL. The helmets may lack proper penetration protection. As such, these helmets fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 218, "Motorcycle Helmets."

Moderate

NHTSAMay 26, 2025Nationwide• MICRO DOT

Salmon Portions (Santa Monica Seafood) – Undeclared Soy (2025)

Atlantic Salmon Portions with Seafood Stuffing was incorrectly labeled and does not declare allergen ingredient (SOY)

FDAMay 24, 2025Nationwide• Santa Monica Seafood Company

SIGNA PET/MR (GE Medical) – Gradient Coil Safety Problem (2025)

GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.

FDAMay 23, 2025Nationwide• GE Medical Systems, LLC

MicroMyst Applicator (Integra) – Sterility Concern (2025)

Lack of sterility assurance.

FDAMay 23, 2025Nationwide• Integra LifeSciences Corp. (NeuroSciences)

Discovery MR750w 3.0T (GE Medical) – Gradient Coil Safety Problem (2025)

GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.

FDAMay 23, 2025Nationwide• GE Medical Systems, LLC

EPIONE Model 30-0001 (Unknown) – Software Guidance Error (2025)

Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.

FDAMay 23, 2025Nationwide

Lincoln Aviator (Lincoln) – Battery System Repair Problem (2025)

Ford Motor Company (Ford) is recalling certain 2020-2021 Lincoln Aviator vehicles equipped with 3.0L PHEV engines that were repaired incorrectly under recall 23V626. A manufacturing defect in one or more of the high voltage battery cells may result in an internal short circuit and battery failure.

NHTSAMay 23, 2025Nationwide• LINCOLN

Lincoln Nautilus (Lincoln) – Display Software Malfunction (2025)

Ford Motor Company (Ford) is recalling certain 2024 Nautilus vehicles. The multimedia module software may cause the panoramic and center displays to reboot, resulting in a blank screen. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard (FMVSS) numbers 111, "Rear Visibility," and 102, "Transmission shift lever sequence, starter interlock, and transmission braking effect," as well as FMVSS numbers 126, 108, 135, 138, 208, 101, and 305.

NHTSAMay 23, 2025Nationwide• LINCOLN

Lincoln Navigator (Lincoln) – Seat Belt Pretensioner Risk (2025)

Ford Motor Company (Ford) is recalling certain 2018-2020 Expedition and Lincoln Navigator vehicles. The seat belt pretensioner in the driver and/or front passenger seat may inadvertently lock the seat belt, which will not allow the belt to retract or extend.

NHTSAMay 23, 2025Nationwide• LINCOLN

Ford Explorer (Ford) – B-Pillar Trim Detachment Risk (2025)

Ford Motor Company (Ford) is recalling certain 2016-2017 Explorer vehicles. The driver and front passenger B-Pillar door trim may detach while driving.

NHTSAMay 23, 2025Nationwide• FORD

Lincoln Aviator (Lincoln) – Audio System Replacement Issue (2025)

Ford Motor Company (Ford) is recalling certain 2020-2023 Lincoln Aviator and Lincoln Corsair vehicles equipped with a Revel Audio System that were repaired incorrectly under recall 22V-953. When the driver's seat belt is not buckled and the vehicle is started, the seat belt warning system may activate the audible warning chime for an insufficient amount of time of less than 4 seconds. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 208, "Occupant Crash Protection."

NHTSAMay 23, 2025Nationwide• LINCOLN

SIGNA Architect AIR (GE Medical) – Gradient Coil Safety Problem (2025)

GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.

FDAMay 23, 2025Nationwide• GE Medical Systems, LLC

Omnipod 5 Insulin System (Unknown) – Decimal Separator Issue (2025)

Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a comma is not recognized as a decimal separator and the user cannot enter a decimal separator in any manual entry screen if the user manually updates their phone settings to a region OUS that uses a decimal separator instead of a period decimal separator or chooses that format as a preference. Use of the affected software may result in over delivery of insulin by increasing the amount of insulin when a decimal separator is not recognized (e.g., 0.1 unit recognized as 1 unit) and thus may result in hypoglycemia, potentially severe.

FDAMay 23, 2025Nationwide

Medline Convenience Kits (Medline) – IV Catheter Issue (2025)

Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.

FDAMay 23, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

Ford Expedition (Ford) – Pre-Collision Software Problem (2025)

Ford Motor Company (Ford) is recalling certain 2020 Expedition and Navigator vehicles that were repaired incorrectly under recall 20V262. The Pre-Collision Assist features, such as forward collision warning and automatic emergency braking, are not functional due to a software error.

NHTSAMay 23, 2025Nationwide• FORD

Ford F-150 Lightning (Ford) – Control Arm Fastener Problem (2025)

Ford Motor Company (Ford) is recalling certain 2024-2025 F-150 Lightning BEV vehicles. The front upper control arm ball joint nut may not have been tightened properly, allowing the front upper control arm to detach from the knuckle assembly.

NHTSAMay 23, 2025Nationwide• FORD

SIGNA Architect (GE Medical) – Gradient Coil Safety Problem (2025)

GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.

FDAMay 23, 2025Nationwide• GE Medical Systems, LLC

Jewel Precision Sterilization Container (Jewel Precision) – FDA Clearance Problem (2025)

The 8-inch model of the Jewel Precision Reusable Rigid Sterilization Container System (i.e., model number: JP-24-8) was not cleared by the FDA. The letter to file justifying the change in size was insufficient.

FDAMay 23, 2025TN• Jewel Precision Sheet Metal & Machining Co, Inc.

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