Agency classClass IIOur severity:High FDA (Devices)·Z-2491-2018·Announced 2018-07-25

Cardinal Health Recalls Hydroline Trumpet Valves Due to Suction Defect

Cardinal Health 200, LLC is recalling Hydroline Trumpet Valves because the suction valve may not close properly, potentially causing continuous suction.

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: The recall is classified as FDA Class II, and the hazard involves a functional defect in a medical device that could lead to continuous suction, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Cardinal Health 200, LLC is recalling Hydroline Trumpet Valves, a sterile, single-use medical device used for suction. The recall involves 63,020 units distributed across 34 U.S. states, the District of Columbia, and several foreign countries, including Belgium, France, Germany, Israel, Italy, the Netherlands, Singapore, and the United Kingdom. Government and military distribution was also reported.

The recall was initiated because the suction valve may not close properly, which could cause continuous suction. This defect poses a risk to patients who rely on the device for intermittent suction control.

Healthcare providers and facilities should stop using the affected valves and contact Cardinal Health 200, LLC for instructions on return or replacement. Consumers should not use the product if they have it in their possession.

The recalled product

Product: Hydroline Trumpet Valve, Trumpet Valve, 5mm x 33cm Probe, Double Spike, Ref ASU1201, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
Manufacturer: Cardinal Health 200, LLC
Category: Medical Device — Suction Valves
Hazard: malfunction
continuous-suction
Affected units: 63,020

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 (20)

Lot numbers 31712
31711
31713
31714
31764
31765
41711
41713
41715
41724
41737
41714
41721
41722
41723
41727
41726
41725
41719
41731

Distribution

Distributed in 34 states:

Part of a larger recall action

This product is one of 11 recalled by Cardinal Health 200, LLC 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 11 products in this recall →

Same manufacturer · Cardinal Health 200, LLC

See all →

Severe
Cardinal Health Recalls Presource Packs with Medtronic Microstream Components
FDA (Devices) · 2026-10-14
High
Cardinal Health Recalls Gynecological Laparoscopy Kits Due to Handpiece Leakage
FDA (Devices) · 2026-10-07
High
Cardinal Health Recalls Presource Packs Due to Potential Handpiece Leakage
FDA (Devices) · 2026-10-07
High
Cardinal Health Recalls Presource Packs with Leaking Handpieces
FDA (Devices) · 2026-10-07
High
Cardinal Health Recalls Stryker StrykeFlow PS and AHTO Tube Set Kits
FDA (Devices) · 2026-10-07

Same hazard · malfunction