CLASS II Device recall · Reported 5 May 2021 · FDA Enforcement Report
ACE MDI Spacer with Small Mask recalled by Smiths Medical ASD
Smiths Medical ASD is recalling ACE MDI Spacer with Small Mask, distributed nationwide in the US. The recall was initiated on 31 Mar 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1516-2021
- FDA event ID
- 87642
- Recalling firm
- Smiths Medical ASD, Minneapolis, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 Mar 2021
- FDA classified
- 29 Apr 2021
- Reported
- 5 May 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Other
- Reason category
- Other Reasons
- Device type
- Masks, Gloves & PPE
Timeline
| 31 Mar 2021 | Recall initiated by company | |
| 29 Apr 2021 | Classified by FDA | +29 days |
| 5 May 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
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.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Device Model Number: 11-1122; Lot Number: 3809856
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 87642| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Palm Cups recalled by Smiths Medical ASD | Smiths Medical ASD | Other | Nationwide |
More recalls from Smiths Medical ASD
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|---|---|---|---|---|---|
| Device | CLASS I | Cadd Solis Hspca Pump ***Updated 5/27/26*** Scope updated recalled | Smiths Medical ASD | Device Malfunction | Nationwide |
| Device | CLASS I | Cadd-Solis Infusion Pump recalled by Smiths Medical ASD | Smiths Medical ASD | Other | Nationwide |
| Device | CLASS I | CADD Solis VIP Ambulatory Infusion Pump recalled by Smiths Medical ASD | Smiths Medical ASD | Other | Nationwide |
| Device | CLASS I | Cadd-Solis VIP Ambulatory Infusion Pump recalled by Smiths Medical ASD | Smiths Medical ASD | Device Malfunction | Nationwide |
| Device | CLASS I | Cadd-Solis Hpca Ambulatory Infusion Pump recalled by Smiths Medical ASD | Smiths Medical ASD | Device Malfunction | Nationwide |
Other Masks, Gloves & PPE recalls
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|---|---|---|---|---|---|
| Device | CLASS II | P28 Phanton Intramedullary Nail System recalled by Paragon 28 | Paragon 28 | Sterility | Nationwide |
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray | Device Malfunction | Nationwide |
| Device | CLASS II | Adapter for Head Positioning recalled by Baxter Healthcare | Baxter Healthcare | Other | Nationwide |
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray | Device Malfunction | Nationwide |
| Device | CLASS II | Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference recalled | O&M Halyard | Other | Nationwide |