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Showing 4121–4140 of 5023 results

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epoc BGEM BUN Test Card (Siemens) – pH result discrepancy (2025)

The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.

FDAMar 19, 2025Nationwide• Siemens Healthcare Diagnostics Inc

Quantum Informatics VIPER (Spectrum Medical) – FDA clearance (2025)

Medical device software marketed without FDA clearance .

FDAMar 19, 2025AL, AZ, AR +35 more• Spectrum Medical Ltd. Harrier 4, Meteor Business Park Cheltenham Road East Gloucester United Kingdom

Vermeer LPSGT (Vermeer) – trailer frame crack risk (2025)

Vermeer Manufacturing Company (Vermeer) is recalling certain 2020-2025 LPSDT, LPSGT, and LPXDT vacuum excavator trailers. The trailer frame may crack or break, reducing the trailer's stability while being towed.

High

NHTSAMar 19, 2025Nationwide• VERMEER

Sterile Normal Saline (Medline) – bottle leakage issue (2025)

It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.

FDAMar 19, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

Ballard Closed Suction Catheters (Avanos) – sterility concern (2025)

Lack of sterility assurance for closed suction catheter systems

FDAMar 19, 2025Nationwide• Avanos Medical, Inc.

Sterile Water (Medline) – bottle leakage issue (2025)

It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.

FDAMar 19, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

Tesla Model X (Tesla) – incorrect air bag (2025)

Tesla, Inc. (Tesla) is recalling certain 2021-2024 Model S and 2021-2025 Model X vehicles. An air bag with the incorrect horn pad may have been installed, preventing the horn from sounding.

NHTSAMar 19, 2025Nationwide• TESLA

Infiniti QX60 (Infiniti) – brake caliper assembly (2025)

Nissan North America, Inc. (Nissan) is recalling certain 2025 Murano, Pathfinder, and INFINITI QX60 vehicles. One or both front brake caliper assemblies may have reduced strength and could break. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 135, "Light Vehicle Brake Systems."

NHTSAMar 19, 2025Nationwide• INFINITI

Brioche Bread and Buns (Baking Group) – Undeclared Allergens (2025)

Undeclared Allergen

Undeclared allergens (soy, milk) and Yellow #5

Class IIModerate

FDAMar 19, 2025TX• Harvey Investments LLC / The Baking Group

Track Control Arm (TRW) – suspension component (2025)

ZF North America, Inc. (ZF) is recalling certain Lemförder track control arms with part number 38526 01, and TRW track control arms with part number JTC 1619. The bush inner sleeve may be too short, which can cause excessive compression of the track control arm and crack the subframe during installation.

NHTSAMar 19, 2025Nationwide• TRW

Favorite Day New York-Style Cheesecake (Dessert Holdings) – Undeclared Pecan (2025)

Undeclared Allergen

Undeclared Pecan. The firm was notified by their customer that when they were placing the product on the shelves, they noticed the wrong product was in the container.

Class IIModerate

FDAMar 19, 2025CA, FL, IA +2 more• Dessert Holdings Llc

Turkey BLT on Sourdough (Hearn Kirkwood) – Incorrect Sandwich (2025)

Undeclared Allergen

Turkey BLT on Sourdough Sandwiches being recalled due to the product having the incorrect sandwich (Peanut Butter & Jelly) in the clamshell container. This incorrect product in the container resulted in an undeclared allergen on the product label (peanuts).

Class IIModerate

FDAMar 19, 2025NY• The Coastal Companies DBA Hearn Kirkwood

Procedure Kits (Medline) – bottle leakage issue (2025)

It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.

FDAMar 19, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

Tesla Cybertruck (Tesla) – light bar detachment (2025)

Tesla, Inc. (Tesla) is recalling certain 2024-2025 Cybertruck vehicles. The light bar can delaminate and detach from the vehicle.

NHTSAMar 18, 2025Nationwide• TESLA

CELL-DYN Ruby (Abbott) – reagent expiration error (2025)

When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.

FDAMar 18, 2025Nationwide• Abbott Laboratories

External Defibrillators DDU-100 (Defibtech) – translation missing (2025)

It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).

FDAMar 18, 2025Nationwide• Defibtech, LLC

External Defibrillators DDU-2200 (Defibtech) – translation missing (2025)

It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).

FDAMar 18, 2025Nationwide• Defibtech, LLC

META-TAN Screw Kit (Smith & Nephew) – compression screw issue (2025)

Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.

FDAMar 18, 2025Nationwide• Smith & Nephew, Inc.

Arepas de Chocolo (Delicias de la Abuela) – Undeclared Soy (2025)

Undeclared Allergen

Undeclared allergen: Soy lecithin, less than 2%

Class IIModerate

FDAMar 18, 2025FL• DELICIAS DE LA ABUELA INC

Apple Juice (Martinelli) – Potential Contamination (2025)

Potential contamination with patulin.

Class IIModerate

FDAMar 18, 2025AL, AZ, AR +25 more• S Martinelli & Company

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