Thayer Medical Recalls AirLife MiniSpacer MDI Adapters Due to Molding Defect
Thayer Medical is recalling 19,340 AirLife MiniSpacer MDI adapters due to a molding defect that may result in incomplete filling of the aerosol dispensing pathway.
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 FDA Class II, and the defect is a manufacturing issue (molding) that affects the dispensing pathway without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Thayer Medical Corporation is recalling 19,340 units of the AirLife MiniSpacer MDI Dispenser Adapter, specifically the 15 mm Dual-Spray model. The recall was initiated after internal data identified a molding defect in the device. This defect results in an incomplete fill of the aerosol dispensing pathway, which is intended to direct aerosolized medication into a breathing circuit.
The affected products are non-sterile, single-use items used in short and long-term critical care environments by licensed healthcare practitioners. The devices are installed in breathing circuits to dispense prescribed aerosol medication. The recall covers units distributed worldwide, including the United States (specifically California and Kentucky) and Europe.
Affected lot numbers for the US are 120320 and 120410, while the affected lot number for Europe is 120405. The devices are packaged in cardboard cartons containing 30 units each. Healthcare facilities and users should stop using the affected devices and contact Thayer Medical Corporation for further instructions on return or replacement.
The recalled product
- Product
- AirLife¿ MiniSpacer¿ MDI Dispenser Adapter. Dual-Spray MiniSpacer¿ Metered Dose Inhaler (MDI) Dispenser/Adapter with 15 mm connections. The 15 mm Dual Spray MiniSpacer¿ is a Metered Dose Inhaler (MDI) Dispenser. It is a non-sterile, single-use item, intended to dispense…
- Manufacturer
- Thayer Medical Corporation
- Affected units
- 19,340
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 (1)
- PRODUCT CODES Affected Lot Number(s) (US): 120320
Distribution
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