# FDA recall Z-1580-2023

> **Smiths Medical ASD Inc.** · Class II · device recall initiated 2023-04-05.

## Product

DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with breathing circuits

## Reason for recall

DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU does not provide the cleaning method, duration of autoclave cycle or specify the number of cycles the product can be reused on a single patient.

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, New Zealand, and Hong Kong.

## Key facts

- **Recall number:** Z-1580-2023
- **Recalling firm:** Smiths Medical ASD Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-04-05
- **Report date:** 2023-05-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1580-2023

## Citation

> AI Analytics. FDA recall Z-1580-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1580-2023. Source: US FDA. Licensed CC0.

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