Official recall record
48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-11-10
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- Smiths Medical Asd Inc
What the authority reported
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2023-11-10 · US FDA — Medical Devices
Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R - 2023-11-10 · US FDA — Medical Devices
1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL - 2023-11-10 · US FDA — Medical Devices
HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP
All 34 official recall notices naming Smiths Medical ASD, Inc. on this site →
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