High Pressure Rotator with O-Ring Seal Defect Recalled Worldwide
Smiths Medical is recalling High Pressure Rotators due to a manufacturing defect affecting O-ring seals. An oversized inner diameter may cause inadequate seal integrity, risking medication under-infusion.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a medication-delivery medical device. Score 4 requires hospitalization reports, which are not reported. This is a risk-of-harm product—seal failure could cause medication under-infusion—without reported injuries, meeting the Score 3 criterion.
Plain-English summary
Smiths Medical Asd Inc is recalling the High Pressure Rotator with Female Luer Lock (List Number MX497HP) due to a manufacturing defect in specific lots. The defect involves an oversized O-ring inner diameter that reduces seal integrity.
An inadequate seal may cause a leak during medication infusion, potentially leading to under-infusion of medication. The affected lot numbers are 4330826 and 4384397, with approximately 31,685 units distributed worldwide to the United States, Canada, and the United Arab Emirates.
The recalled product
- Product
- HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP
- Manufacturer
- Smiths Medical Asd Inc
- Category
- Medical Device
- Affected units
- 31,685
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 Number: 4330826 4384397
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 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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