Smiths Medical ACE MDI Spacer with Small Mask Recall: Incorrect Shipping Labels
Smiths Medical recalls ACE MDI Spacers with Small Masks due to potential incorrect shipping box labels. This may affect product identification but does not pose a safety risk.
Lower-risk 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.
Contact the company
What happened, in plain English
Smiths Medical is recalling ACE MDI Spacers with Small Masks because some units may have incorrect shipping box labels. This issue does not pose a safety risk but could lead to confusion about product identification. Read more at govinfonow.com/recall/62877-smiths-medical-ace-mdi-spacer-with-small-mask-recall-incorrect.
Source Summary by GovInfoNow · govinfonow.com/recall/62877-smiths-medical-ace-mdi-spacer-with-small-mask-recall-incorrect · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1516-2021
Cite this page
“Smiths Medical ACE MDI Spacer with Small Mask Recall: Incorrect Shipping Labels.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62877-smiths-medical-ace-mdi-spacer-with-small-mask-recall-incorrect. Based on FDA recall #Z-1516-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1516-2021%22&limit=1).
Why it’s dangerous
The recall is due to potential incorrect shipping box labels on some units. This could cause confusion about which units are being used but does not affect the device's safety or function.
Who’s affected
Healthcare professionals using ACE MDI Spacers with Small Masks for medical patients are likely affected. Patients using these devices are at minimal risk as the issue does not impact safety.
How to tell if you have this one
Check for the model number 11-1122 and lot number 3809856 on the shipping box. The product is designed for use with metered dose inhalers and ventilated patients.
- Brand
Smiths Medical- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- 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.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1515-2021 | Palm Cups - Product Usage: intended to be used to percuss the chest wall to mobilize the secretions within the bronchial tree.; Device Model Number: 55-4090; Lot Number: 3768545 | 682 units |
| Z-1516-2021 | 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.; Device Model Number: 11-1122; Lot Number: 3809856 | 250 units |
What to do — step by step
Check Shipping Labels
Verify the model number 11-1122 and lot number 3809856 on the shipping box to confirm the product.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 2 states.
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Minnesota, Pennsylvania.
Recall timeline
FDA terminated this recall 22 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1516-2021 (March 31, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1516-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.