The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1476-2021·Announced 2021-04-28

Smiths Medical Recalls Manifold Rotators Due to Incomplete Welds

Smiths Medical ASD Inc. is recalling specific lots of manifold rotators and related components because they may have insufficient or incomplete welds.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (incomplete welds) in medical devices used for pressure monitoring and IV fluid control, which poses a risk of significant injury or property damage.

Plain-English summary

Smiths Medical ASD Inc. is recalling specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks, Tubing, and LogiCal Kits. The affected products are components used in various cardiac kits, including pressure monitoring devices and interventional imaging devices. The recall involves 1,380 units of manifold rotators, specifically models MX1232MR, MX1233MR, MX1322MR, and MX1333MR.

The recall was initiated because these components may have been manufactured with insufficient or incomplete welds. Stopcocks and manifolds are used to control the direction of IV fluid flow and are components of extravascular blood-pressure transducers. The affected lots were distributed nationwide in the United States, including Puerto Rico, as well as in Austria, Canada, Chile, Ecuador, Hong Kong, Mexico, Slovenia, Brazil, South Africa, Colombia, and Japan.

Healthcare facilities and consumers should stop using the affected products immediately. Users should check their inventory for the specific model and lot numbers listed in the recall notice. For more information, contact Smiths Medical ASD Inc. or refer to the FDA recall notice Z-1476-2021.

The recalled product

Product
Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1232MR b. 250 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1233MR c. 550 2 GANG MANIFOLD ROTATOR, OPEN HANDLE, Model Number MX1322MR d. 550 3 GANG MANIFOLD ROTATOR, OFF HANDLE…
Manufacturer
Smiths Medical ASD Inc.
Category
Medical Device — Cardiac Monitoring Components
Hazard
Affected units
1,380

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 (6)

  • a. Model Number MX1232MR
  • Lot Numbers: 4027757 b. Model Number MX1233MR
  • Lot Numbers: 4076456 c. Model Number MX1322MR
  • Lot Numbers: 3992363
  • 4011839 d. Model Number MX1333MR
  • Lot Numbers: 4016439

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 12 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.

See all 12 products in this recall →

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