Mallinckrodt Evac Tracheal Tubes Recalled for Unsealed Packaging
Stryker is recalling four Mallinckrodt Evac Tracheal Tubes because the packaging may not be sealed, potentially compromising sterility.
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, but the source text describes a packaging defect (unsealed) without reporting specific illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stryker Sustainability Solutions is recalling four units of Mallinckrodt Evac Tracheal Tubes, Model #124170-MALLINCKRODT & 124175, Lot #481938U. The recall was initiated because the device packaging may not be sealed.
The affected units were distributed in the United States to Kentucky. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
Healthcare facilities and consumers who have these specific tracheal tubes should stop using them and contact Stryker Sustainability Solutions for instructions on return or replacement.
The recalled product
- Product
- Mallinckrodt Evac Tracheal Tubes Model #124170-MALLINCKRODT & 124175
- Manufacturer
- Stryker Sustainability Solutions
- Category
- Medical Device — Tracheal Tubes
- Affected units
- 4
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)
- Lot #481938U
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Stryker Sustainability Solutions 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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