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Showing 2201–2220 of 68218 results

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Grape Tomatoes (Salad and Go) – Listeria Risk (2025)

Potential to be contaminated with Listeria monocytogenes

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

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)

Listeria

Potential to be contaminated with Listeria monocytogenes

Class IHigh

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

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

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.

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

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

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