Smiths Medical Recalls ACE MDI Spacers Due to Labeling Errors
Smiths Medical ASD Inc. is recalling 250 units of ACE MDI Spacers with Small Masks because shipping box labels may be incorrect.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as Moderate because it involves a minor labeling error (incorrect shipping box labels) without reported injuries or illnesses, fitting the rubric criteria for minor labeling errors.
Plain-English summary
Smiths Medical ASD Inc. is recalling 250 units of ACE MDI Spacers with Small Masks. The recall was initiated after the firm received complaints indicating that the shipping box labels for this specific lot may be incorrect.
The affected product is the ACE MDI Spacer with Small Mask, Model Number 11-1122, Lot Number 3809856. These devices are designed to assist with the delivery of aerosolized medications from metered dose inhaler canisters and with mechanically ventilated patients.
The recall covers units distributed worldwide, including nationwide distribution in the United States (specifically Pennsylvania and Minnesota) and in Colombia, Germany, Greece, Hong Kong, Qatar, Thailand, and the United Arab Emirates. Consumers and healthcare providers should check their inventory for this specific lot number and contact the manufacturer for instructions on how to proceed.
The recalled product
- 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.
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
- Affected units
- 250
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Device Model Number: 11-1122
- Lot Number: 3809856
Distribution
Part of a larger recall action
This product is one of 2 recalled by Smiths Medical ASD Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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