All Recalls

92,900 total recalls in our database

Salmonella. Greek Salad Kit made with recalled cucumbers sourced from Bedner Grower's Company which may be contaminated with Salmonella and implicated in an ongoing outbreak.

May 21, 2025 Dairy & Eggs View Details →

Contains cucumber contaminated with Salmonella recalled by Bedner Growers Inc.

May 21, 2025 Other Foods View Details →

Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA).

Jan 24, 2025 Diagnostic Equipment Nationwide View Details →

AcoSound. Model Number: LW12-BTE-M

HANGZHOU ACOSOUND TECHNOLOGY CO.

🏥 Medical Devices Class I - Dangerous

Three issues 1. Label error: The manufacturer information in the labeling is not correct, the manufacturer's name is mislabeled as "Developed by AcoSound," Correct should be "Manufactured by Hangzhou AcoSound." And the labeling has no statement of the place of business for the manufacturer. 2. Customer information: The customer "Blaid" information is not correctly marked; Blaid is not the manufacturer. 3. UDI Information: The UDI information is incomplete and without DI information and correct Pl information, not complied with UDI label requirements.

Apr 25, 2025 Other Medical Devices Nationwide View Details →

Ami HTX.

Spectral Instruments

🏥 Medical Devices Class I - Dangerous

The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not correspond exactly to the labeling stipulated by the FDA / CDRH.

May 13, 2025 Other Medical Devices View Details →

UROSKOP Omnia Max. Model Number: 10762473

Siemens Medical Solutions USA

🏥 Medical Devices Class I - Dangerous

A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.

Jun 4, 2025 Other Medical Devices Nationwide View Details →

Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death.

May 12, 2025 Diagnostic Equipment Nationwide View Details →