Stryker Launcher Guiding Catheter Recalled for Unsealed Packaging
Stryker is recalling two units of the Launcher Guiding Catheter because the device packaging may not be sealed.
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 involves a packaging integrity issue (unsealed packaging) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Stryker Sustainability Solutions is recalling two units of the Launcher Guiding Catheter, Model #LA6EBU30. This medical device is used in the coronary or peripheral vascular system. The recall was initiated because the device packaging may not be sealed.
The affected units are from Lot #481938U. The distribution pattern indicates that the devices were distributed in the United States to Kentucky. The agency has classified this recall as Class II.
Consumers and healthcare providers should check their inventory for this specific model and lot number. If the packaging is found to be unsealed, the device should not be used. Users should contact Stryker Sustainability Solutions for further instructions on how to return or dispose of the affected units.
The recalled product
- Product
- Launcher Guiding Catheter Model #LA6EBU30. Used in the coronary or peripheral vascular system..
- Manufacturer
- Stryker Sustainability Solutions
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 2
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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