Cardinal Health 200, LLC: Medical Device Recall in 2024 - (Recall #: Z-0674-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL

Product Classification:

Class II

Date Initiated: November 1, 2024

Date Posted: December 18, 2024

Recall Number: Z-0674-2025

Event ID: 95727

Reason for Recall:

Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancement of Medical Instrumentation) Level 3 protection requirements.

Status: Ongoing

Product Quantity: 940,203 total units

Code Information:

All Lots. AT6100 UDI-DI: CS (01) 50192253048252 EA (01) 20192253048251; AT6100-XL UDI-DI: CS (01) 50192253048269 EA (01) 20192253048268; AT6200 UDI-DI: CS (01) 50192253048276 EA (01) 20192253048275; AT6200-XL UDI-DI: CS (01) 50192253048283 EA (01) 20192253048282

Distribution Pattern:

US Nationwide. Canada, UAE

Voluntary or Mandated:

Voluntary: Firm initiated