Cardinal Health Recalls Hydroline Trumpet Valves Due to Suction Defect
Cardinal Health 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 unintended continuous suction, representing a risk of harm where specific injury reports are not detailed in the source text.
Plain-English summary
Cardinal Health 200, LLC is recalling Hydroline Trumpet Valves, Reference ASU1211, Lot 41736. The product is a sterile, single-use, prescription medical device manufactured in Waukegan, Illinois.
The recall was initiated because the suction valve may not close properly, which could result in continuous suction. A total of 63,020 valves were distributed to various U.S. states, government and military facilities, and several foreign countries including Belgium, France, Germany, Israel, Italy, the Netherlands, Singapore, and the United Kingdom.
Healthcare providers and facilities should stop using the affected valves and contact Cardinal Health for further instructions on return or disposal.
The recalled product
- Product
- Hydroline Trumpet Valve, Trumpet Valve, 5mm x 28cm Probe, Double Spike, Ref ASU1211, packaged 1/box, 12 boxes/case, single use, RX, Sterile. Manufactured For Cardinal Health, Waukegan, IL.
- Manufacturer
- Cardinal Health 200, LLC
- 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 (1)
- Lot number 41736.
Distribution
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 →Related recalls
Same manufacturer · Cardinal Health 200, LLC
See all →- SevereCardinal Health Recalls Presource Packs with Medtronic Microstream Components
FDA (Devices) · 2026-10-14
- HighCardinal Health Recalls Gynecological Laparoscopy Kits Due to Handpiece Leakage
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Presource Packs Due to Potential Handpiece Leakage
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Presource Packs with Leaking Handpieces
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Stryker StrykeFlow PS and AHTO Tube Set Kits
FDA (Devices) · 2026-10-07
Same hazard · functional defect
See all →- ModerateSunMed Tracheal Tube Recalled Due to Suction Catheter Passage Issues
FDA (Devices) · 2026-09-23
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- SevereAbiomed Recalls Impella Optical Controllers Due to Purge Sensor Defect
FDA (Devices) · 2026-09-23
- SevereAbiomed Recalls Automated Impella Controllers Due to Purge Sensor Defect
FDA (Devices) · 2026-09-23
- HighMaquet Critical Care Recalls Y Sensor Modules for Electrical Safety Testing Omission
FDA (Devices) · 2026-08-26
Similar recalls
- HighCardinal Health Recalls Salem Sump Stomach Tubes Due to Valve Breakage
FDA (Devices) · 2024-10-02
- HighCardinal Health Salem Sump Stomach Tubes Recalled for Anti-Reflux Valve Breakage
FDA (Devices) · 2024-10-02
- HighCardinal Health Recalls Jackson-Pratt Silicone Flat Drains Due to Sterility Concerns
FDA (Devices) · 2017-05-31
- SevereArgyle Suction Catheter Trays with Chimney Valve recalled for defective components
FDA (Devices) · 2024-02-28
- HighCardinal Health Recalls Jackson-Pratt Silicone Round Drains Due to Sterility Concerns
FDA (Devices) · 2017-05-31
- HighCardinal Health Recalls Jackson-Pratt Hemaduct Silicone Round Drains
FDA (Devices) · 2017-05-31