Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2023 - (Recall #: Z-0507-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Stay Safe Cap

Product Classification:

Class II

Date Initiated: October 10, 2023

Date Posted: December 13, 2023

Recall Number: Z-0507-2024

Event ID: 93396

Reason for Recall:

Updating the labeling to include additional warnings and contraindications for potential side effects.

Status: Ongoing

Product Quantity: 18,236,160 eaches

Code Information:

Model No. 050-95012; UDI-DI: 00840861100835; All Lots.

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated