Terumo Overpressure Safety Valve Recall Due to No Flow Reports
Terumo CVS is recalling custom surgical kits containing Overpressure Safety Valves due to reports of no flow through the valve.
What this means for you
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. The hazard involves a functional failure (no flow) in a medical device used in surgery, which poses a risk of harm, but the source text does not report specific injuries or hospitalizations, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling custom surgical kits that contain the TERUMO(R) Overpressure Safety Valve, reference LH130 and LH130J. The recall involves 214,146 units distributed worldwide, including in the US, Canada, Colombia, UK, Belgium, and Japan.
The recall was initiated after Terumo CVS received reports of no flow through the over-pressure safety (OPS) Valve. This defect could potentially impact the functionality of the surgical kits during use.
Healthcare providers and facilities should stop using the affected kits and contact Terumo CVS for instructions on returning or replacing the products. The specific catalog numbers and lot codes affected are listed in the official FDA recall documentation.
The recalled product
- Product
- Custom surgical kits containing TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 and (b) LH130J Catalog numbers: US distribution: LH130 74369 71156 71551-02 71413 71692
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Category
- Medical Device — Surgical Kits
- Affected units
- 214,146
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Terumo Cardiovascular Systems Corporation 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 2 products in this recall →Related recalls
Same manufacturer · Terumo Cardiovascular Systems Corporation
See all →- HighCDI OneView System BPM Probe temperature sensor measurement inaccuracy
FDA (Devices) · 2025-07-02
- HighTerumo CDI OneView Monitor Probe May Fail to Display Oxygen Saturation Data
FDA (Devices) · 2025-04-09
- HighCardiovascular Procedure Kits Recalled for Pressure Relief Valve Defect
FDA (Devices) · 2024-04-10
- HighCAPIOX FX25 Oxygenator Recalled for Potential Leaks from Improper Bonding
FDA (Devices) · 2023-04-12
- HighTerumo Recalls CAPIOX NX19 Oxygenator Due to Improper Bonding
FDA (Devices) · 2023-04-12
Same hazard · device malfunction
See all →- HighPhilips Incisive CT Recalled for Potential Failure to Trigger Clinical Scan
FDA (Devices) · 2026-09-02
- HighBD Needle Kit for Powered Driver Recall Due to Removal Difficulty
FDA (Devices) · 2026-08-26
- HighBoston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices
FDA (Devices) · 2026-08-26
- HighIntegrated Medcraft Recalls First Aid Kits with Defective Airway Tips
FDA (Devices) · 2026-08-12
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12