FDA Device recall Z-0675-2025
Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, Product Codes AT6588-2XL, AT6588-BD, AT6588-XL, AT6688-2XL, A…
- FDA Device
- Class II
- ongoing
- Published 2024-12-18
On 2024-12-18 the FDA classified a Class II recall of Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, Product Codes AT6588-2XL, AT6588-BD, AT6588-XL, AT6688-2XL, A… by Cardinal Health 200, citing 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 Advance….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0675-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-01 |
| Published | 2024-12-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Cardinal Health 200 |
| Distribution | US |
Product
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
Reason
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.
Identifiers
| code_info | All lots. AT6588-2XL UDI-DI: CS (01) 50885380166639 EA (01) 20885380166638; AT6588-BD UDI-DI: CS (01) 50885380166646…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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FDA Device · Class II · 2026-10-07 · Cardinal Health 200 - Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLAC
FDA Device · Class II · 2026-10-07 · Cardinal Health 200 - Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAP CHOLE , Catalog Number: PGCGLCBAC
FDA Device · Class II · 2026-10-07 · Cardinal Health 200 - Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAVH , Catalog Number: PB63VHSTC
FDA Device · Class II · 2026-10-07 · Cardinal Health 200
All Cardinal Health 200 recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0675-2025%22
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