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Consumer Product Recalls
127,277 recalls from the U.S. Consumer Product Safety Commission, newest first.
August 13, 2025Medical DevicesFDA
Beckman Coulter, Inc. recalls DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461
Hazard: Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.
August 13, 2025Medical DevicesFDA
Beckman Coulter, Inc. recalls UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
Hazard: Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.
August 13, 2025Medical DevicesFDA
Beckman Coulter, Inc. recalls DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456
Hazard: Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.
August 13, 2025Medical DevicesFDA
Beckman Coulter, Inc. recalls DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457
Hazard: Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.
August 13, 2025Medical DevicesFDA
Beckman Coulter, Inc. recalls UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100
Hazard: Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.
August 13, 2025Medical DevicesFDA
DRG International, Inc. recalls Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total
Hazard: An incoming complaint reported that the expiration date on the kit box label and Certificate of Analysis (CoA) exceeded the shelf life of the standards and control solutions in the kit by 2 months (i.e., 2026-03-31 instead of 2026-01-31). The expiration dates on the bottle labels were correct (i.e., 2026-01-31).
August 13, 2025Medical DevicesFDA
Beckman Coulter Inc. recalls UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,
Hazard: Beckman Coulter identified that the Unsaturated Iron Binding Capacity (UIBC) assay is not meeting their labeled hemoglobin interference claims of no significant interference (i.e., less than 10%) up to 200 mg/dL hemoglobin as indicated in their instructions for use. Initial internal testing confirmed that samples with low UIBC levels failed the claimed hemolysis interference specifications with reported biases up to -43.6 % UIBC when hemolyzed serum samples contained 200 mg/dL hemoglobin.
August 13, 2025Medical DevicesFDA
AVID Medical, Inc. recalls ROBOTIC URO/GYN PACK. Medical convenience kit.
Hazard: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
August 13, 2025Medical DevicesFDA
AVID Medical, Inc. recalls ROBOTIC PROSTATECTOMY PACK. Medical convenience kit.
Hazard: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
August 13, 2025Medical DevicesFDA
AVID Medical, Inc. recalls PARTIAL NEPHRECTOMY PACK. Medical convenience kit.
Hazard: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
August 13, 2025Medical DevicesFDA
AVID Medical, Inc. recalls PARTIAL NEPHRECTOMY - ROBOTIC. Medical convenience kit.
Hazard: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
August 13, 2025Medical DevicesFDA
AVID Medical, Inc. recalls PACK GENERAL ROBOTIC. Medical convenience kit.
Hazard: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
August 13, 2025Medical DevicesFDA
AVID Medical, Inc. recalls MAJOR THORACOSCOPY BASIN. Medical convenience kit.
Hazard: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
August 13, 2025Medical DevicesFDA
AVID Medical, Inc. recalls LAVH PACK. Medical convenience kit.
Hazard: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
August 13, 2025Medical DevicesFDA
AVID Medical, Inc. recalls LAPAROSCOPY PACK. Medical convenience kit.
Hazard: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
August 13, 2025Medical DevicesFDA
AVID Medical, Inc. recalls LAPAROSCOPIC PROSTATECTOMY. Medical convenience kit.
Hazard: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
August 13, 2025Medical DevicesFDA
AVID Medical, Inc. recalls LAPAROSCOPIC GYN. Medical convenience kit.
Hazard: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
August 13, 2025Medical DevicesFDA
AVID Medical, Inc. recalls LAP CHOLE PACK. Medical convenience kit.
Hazard: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
August 13, 2025Medical DevicesFDA
AVID Medical, Inc. recalls HVI CARDIAC ROBOT PACK. Medical convenience kit.
Hazard: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
August 13, 2025Medical DevicesFDA
AVID Medical, Inc. recalls GYN ROBOTIC PACK. Medical convenience kit.
Hazard: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
August 13, 2025Medical DevicesFDA
AVID Medical, Inc. recalls GYN LAPAROSCOPY PACK. Medical convenience kit.
Hazard: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
August 13, 2025Medical DevicesFDA
AVID Medical, Inc. recalls GS ENDOSCOPY PACK. Medical convenience kit.
Hazard: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
August 13, 2025Medical DevicesFDA
AVID Medical, Inc. recalls GENERAL ROBOTIC PACK. Medical convenience kit.
Hazard: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
August 13, 2025Medical DevicesFDA
AVID Medical, Inc. recalls GENERAL LAPAROSCOPY TRAY. Medical convenience kit.
Hazard: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
August 13, 2025Medical DevicesFDA
AVID Medical, Inc. recalls GEN LAPAROSCOPY PACK. Medical convenience kit.
Hazard: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
August 13, 2025Medical DevicesFDA
AVID Medical, Inc. recalls DAVINCI UROLOGY. Medical convenience kit.
Hazard: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
August 13, 2025Medical DevicesFDA
AVID Medical, Inc. recalls DAVINCI TRUCUSTOM BUNDLE. Medical convenience kit.
Hazard: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
August 13, 2025Medical DevicesFDA
AVID Medical, Inc. recalls DA VINCI PACK URO/PROSTATE. Medical convenience kit.
Hazard: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
August 13, 2025Medical DevicesFDA
AVID Medical, Inc. recalls CT DAVINCI. Medical convenience kit.
Hazard: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
August 13, 2025Medical DevicesFDA
AVID Medical, Inc. recalls CARDIAC ROBOT PACK. Medical convenience kit.
Hazard: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.