Cardinal Health 200, LLC: Medical Device Recall in 2024 - (Recall #: Z-0675-2025)

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:

Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, Product Codes AT6588-2XL, AT6588-BD, AT6588-XL, AT6688-2XL, AT6688-BD, and AT6688-XL

Product Classification:

Class II

Date Initiated: November 1, 2024

Date Posted: December 18, 2024

Recall Number: Z-0675-2025

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. AT6588-2XL UDI-DI: CS (01) 50885380166639 EA (01) 20885380166638; AT6588-BD UDI-DI: CS (01) 50885380166646 EA (01) 20885380166645; AT6588-XL UDI-DI: CS (01) 50885380166653 EA (01) 20885380166652; AT6688-2XL UDI-DI: CS (01) 50885380166660 EA (01) 20885380166669; AT6688-BD UDI-DI: CS (01) 50885380166677 EA (01) 20885380166676; AT6688-XL UDI-DI: CS (01) 50885380166684 EA (01) 20885380166683

Distribution Pattern:

US Nationwide. Canada, UAE

Voluntary or Mandated:

Voluntary: Firm initiated