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Showing 3261–3280 of 92420 results

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Prima 2mm Eccentrical Adaptor (Limacorporate) – Marking Missing (2025)

There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.

FDAMay 19, 2025Nationwide• Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy

Prima 4mm Eccentrical Adaptor (Limacorporate) – Marking Missing (2025)

There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.

FDAMay 19, 2025Nationwide• Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy

Ezetimibe and Simvastatin Tablets (Glenmark) – Impurity Specification Failure (2025)

Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.

Class IIILow

FDAMay 19, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Michelin Agilis CrossClimate Tire (Michelin) – Tread Separation (2025)

Michelin North America, Inc. (Michelin) is recalling certain Agilis Cross Climate C-Metric tires, size 185/60R15C. Chunks of tread rubber may detach from the shoulder blocks. As such, these tires fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 139, "New Pneumatic Radial Tires for Light Vehicles."

NHTSAMay 19, 2025Nationwide• MICHELIN

Hummingbird EMG Kit (Neurovision Medical) – Packaging Error (2025)

Product packaging contains the wrong part number and kit contents.

FDAMay 19, 2025CA• Neurovision Medical Products Inc

Non Fat Dry Milk (Crystal Creamery) – Salmonella Potential (2025)

Potential contamination with Salmonella.

FDAMay 19, 2025CA, TX• Crystal Creamery Inc.

2025 Isuzu NRR EV (Isuzu) – Electrical System Risk (2025)

Isuzu Motors Limited (Isuzu) is recalling certain 2025 NRR-EV vehicles. A gap between the bus bar and connection terminal may cause the system to overheat and turn off the drive motor.

NHTSAMay 16, 2025Nationwide• ISUZU

GE Versana Ultrasound (GE Healthcare) – Fetal Weight Measurement (2025)

GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previous obstetric patient data in the Whizz report. This could potentially lead to an incorrect clinical decision due to inaccuracy in the fetal size and growth calculation.

FDAMay 16, 2025Nationwide• GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.

GE LOGIQ F R3 Ultrasound (GE Healthcare) – Fetal Weight Measurement (2025)

GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previous obstetric patient data in the Whizz report. This could potentially lead to an incorrect clinical decision due to inaccuracy in the fetal size and growth calculation.

FDAMay 16, 2025Nationwide• GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.

Vegetable Singara (South Asian Food) – Undeclared Peanut (2025)

Undeclared Nuts

Contains undeclared peanut

FDAMay 16, 2025CA, MA, MN +5 more• South Asian Food Inc.

Cucumbers (Bedner Growers) – Salmonella Risk (2025)

Cucumbers may be potentially contaminated with Salmonella

FDAMay 16, 2025FL• Bedner Growers, Inc.

Raspberry Croissant (Element 112) – Undeclared Wheat (2025)

Undeclared Gluten

Undeclared wheat

Class IIModerate

FDAMay 16, 2025IN, MI, OH• Element 112, LLC

Q-Stop Suture Device (Drs Vascular) – Unknown Issue (2025)

XXX

FDAMay 16, 2025Nationwide• Drs Vascular, Inc

Chocolate Croissant (Element 112) – Undeclared Wheat (2025)

Undeclared Gluten

Undeclared wheat

Class IIModerate

FDAMay 16, 2025IN, MI, OH• Element 112, LLC

Butter Croissant Bun (Element 112) – Undeclared Wheat (2025)

Undeclared Gluten

Undeclared wheat

Class IIModerate

FDAMay 16, 2025IN, MI, OH• Element 112, LLC

Broselow Pediatric Tape (SunMed) – Incorrect Zone Information (2025)

The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone. Using the incorrect values in the Red zone could lead to shocking a patient with an excessive dose of joules, causing significant harm including burns, heart damage, and cardiac arrest. Incorrect values in the Orange zone could lead to overdosing the patient with sodium bicarbonate and cause metabolic alkalosis, electrolyte imbalances, tissue damage, and worsen respiratory status. Incorrect information in the Grey may lead to underdosing the patient with sodium bicarbonate and may cause reduced myocardial contractility, decreased response to vasopressors, and increased risk of dysrhythmia.

FDAMay 15, 2025Nationwide• SunMed Holdings, LLC

Beacon Tip Angiographic Catheter (Cook) – Tip Separation (2025)

Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.

FDAMay 15, 2025Nationwide• Cook Incorporated

ARTIS Angiography System (Siemens) – Dose Sensor Error (2025)

In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.

FDAMay 15, 2025Nationwide• Siemens Medical Solutions USA, Inc

2026 IC Bus CESB (IC Bus) – Parking Brake Issue (2025)

International Motors, LLC (International) is recalling certain 2025-2026 IC Bus CESB school buses. The parking brake can be released when the wheelchair platform lift is deployed. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 403, "Platform Lift Systems."

NHTSAMay 15, 2025Nationwide• IC BUS

Medline Umbilical Tray (Medline) – Packaging Defect (2025)

There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product.

FDAMay 15, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

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