ACE MDI Spacer with Small Mask — Class II medical device recall Z-1516-2021
Terminated recall by Smiths Medical ASD Inc., reported 2021-05-05, distributed nationwide. The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups
| Recall number | Z-1516-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD Inc., Minneapolis, MN, United States |
| Recall initiated | 2021-03-31 |
| Classified | 2021-04-29 |
| Reported by FDA | 2021-05-05 |
| Terminated | 2023-01-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, DE, GR, HK, QA, TH |
| Quantity | 250 units |
| Reason classes | labeling |
| Lot numbers | 3809856 |
| Model numbers | 11-1122 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1516-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.