TERUMO — Class II medical device recall Z-0256-2018
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2017-12-27. Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (O
| Recall number | Z-0256-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Cardiovascular Systems Corporation, Elkton, MD, United States |
| Recall initiated | 2017-06-27 |
| Classified | 2017-12-18 |
| Reported by FDA | 2017-12-27 |
| Terminated | 2019-07-16 |
| Countries outside the US | BE, CA, CO, GB, JP |
| Quantity | 297,222 units |
| Lot numbers | LH130, RH14, RH21, RK11, RK18, RK20, RL02, RL15, RM01, RM06, RM20, RM22, RN10, RN24, RP01, RP08, TA19, TD16, TE13, TE27, TF05, TF14, TF21, TF27, TG04, TG11, TG17, TG19, TH06, TH16, TH20, TK10, TK24, TL01, TL08, TL21, TM12, TM28, TN09, TP03 and 35 more |
| Model numbers | LH130, LH130J |
Product
TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J
Reason for recall
Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (OPS) Valve.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0256-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.