# FDA recall Z-1516-2021

> **Smiths Medical ASD Inc.** · Class II · device recall initiated 2021-03-31.

## Product

ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the delivery of aerosolized medications from metered dose inhaler canisters and with mechanically ventilated patients.

## Reason for recall

The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of PA and MN. The countries of Columbia, Germany, Greece, Hong Kong, Qatar, Thailand, and United Arab Emirates.

## Key facts

- **Recall number:** Z-1516-2021
- **Recalling firm:** Smiths Medical ASD Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-31
- **Report date:** 2021-05-05
- **Termination date:** 2023-01-31

- **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-1516-2021

## Citation

> AI Analytics. FDA recall Z-1516-2021. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/Z-1516-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*