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Showing 3101–3120 of 4952 results

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O-arm O2 Imaging System (Medtronic) – Gantry Support Damage (2025)

A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.

FDAMay 27, 2025Nationwide• Medtronic Navigation, Inc.-Boxborough

Cooked Breakfast Potato (Salad and Go) – Listeria Risk (2025)

Potential to be contaminated with Listeria monocytogenes

FDAMay 27, 2025AZ, NV• AND GO CONCEPTS DBA SALAD AND GO

Cooked Breakfast Potato (Salad and Go) – Listeria Risk (2025)

Listeria

Potential to be contaminated with Listeria monocytogenes

Class IHigh

FDAMay 27, 2025AZ, NV• AND GO CONCEPTS DBA SALAD AND GO

Red Cabbage (Salad and Go) – Listeria Risk (2025)

Potential to be contaminated with Listeria monocytogenes

FDAMay 27, 2025AZ, NV• AND GO CONCEPTS DBA SALAD AND GO

Fluoxetine Tablets (Torrent Pharma) - CGMP Nitrosamine Deviation (2025)

CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.

Class IIModerate

FDAMay 27, 2025Nationwide• Torrent Pharma Inc.

Sliced Cucumber (Salad and Go) – Listeria Risk (2025)

Potential to be contaminated with Listeria monocytogenes

FDAMay 27, 2025AZ, NV• AND GO CONCEPTS DBA SALAD AND GO

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

Undeclared Allergen

undeclared pecans

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

Roasted Brussels Sprouts (Salad and Go) – Listeria Risk (2025)

Potential to be contaminated with Listeria monocytogenes

FDAMay 27, 2025AZ, NV• AND GO CONCEPTS DBA SALAD AND GO

Shredded Carrot (Salad and Go) – Listeria Risk (2025)

Potential to be contaminated with Listeria monocytogenes

FDAMay 27, 2025AZ, NV• AND GO CONCEPTS DBA SALAD AND GO

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."

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

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