Class IIICompletedZ-2090-2025
STRATASYS LTD recalls TrueDent Clear
Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month.…
STRATASYS LTDJul 16, 2025
Class III recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 121–125 of 125 recalls
Class IIIOngoingZ-2046-2025
LUMITHERA INC recalls Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age…
U.S. customers were shipped devices that were configured for the European Union and were unable to plug the device in the electrical outlet.
LUMITHERA INCWAJul 9, 2025
Class IIIOngoingZ-1976-2025
HANGZHOU ACOSOUND TECHNOLOGY CO., LTD. recalls AcoSound. Model Number: LW12-BTE-M
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…
HANGZHOU ACOSOUND TECH…Jun 25, 2025
Class IIIOngoingZ-1815-2025
Beckman Coulter Ireland, Inc. recalls Apo B Reagent
The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B patient result which could exceed the total…
Beckman Coulter Irelan…Jun 4, 2025
Class IIIOngoingZ-0805-2025
Qualigen Inc recalls The FastPack IP Sex Hormone Binding Globulin Immunoassay
Three lots of the FastPacks kitted into the FastPack SHBG Complete Kits were labeled with the incorrect expiration date. The following is a listing of affected lots: Lot Number: 2408018-1, 2409015-1, and 2409015-2.…
Qualigen IncCAJan 15, 2025