Official product recall notices and clearly labeled enforcement reference records.
Reference notice · device
There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect product identification or selection, potentially resulting in use with an incompatible bed frame.
Deerfield, IL, US · Updated 9/24/2026, 12:00:00 AM UTC
Source: FDA — device enforcement referenceReference notice · device
There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect product identification or selection, potentially resulting in use with an incompatible bed frame.
Deerfield, IL, US · Updated 9/24/2026, 12:00:00 AM UTC
Source: FDA — device enforcement referenceReference notice · device
There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect product identification or selection, potentially resulting in use with an incompatible bed frame.
Deerfield, IL, US · Updated 9/24/2026, 12:00:00 AM UTC
Source: FDA — device enforcement referenceReference notice · drug
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
Deerfield, IL, US · Updated 9/16/2026, 12:00:00 AM UTC
Source: FDA — drug enforcement referenceReference notice · drug
Presence of particulate matter: Particulates identified as fiberglass
Deerfield, IL, US · Updated 9/9/2026, 12:00:00 AM UTC
Source: FDA — drug enforcement referenceReference notice · device
A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.
Deerfield, IL, US · Updated 8/31/2026, 12:00:00 AM UTC
Source: FDA — device enforcement referenceReference notice · device
A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.
Deerfield, IL, US · Updated 8/31/2026, 12:00:00 AM UTC
Source: FDA — device enforcement reference