Ra Medical Systems DABRA Catheter 5F — Class II medical device recall Z-2006-2020
Terminated recall by Ra Medical Systems, Inc., reported 2020-05-20, distributed nationwide. The firm has become aware there is a potential problem with its DABRA catheters resulting in higher catheter c
| Recall number | Z-2006-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ra Medical Systems, Inc., Carlsbad, CA, United States |
| Recall initiated | 2019-09-19 |
| Classified | 2020-05-14 |
| Reported by FDA | 2020-05-20 |
| Terminated | 2023-07-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | FR, GB, IT, NL, PK |
| Quantity | 5,082 products |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00842362100031 |
| NDC | 01222-5000-01 |
| Lot numbers | 18-090400-094, 19-092400-041, 2797 |
| Model numbers | 1222-5000-01 |
| Expiration dates | 2019-09-20, 2019-09-24, 2019-12-13 |
Product
Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400-094, USE BY: 2019-09-24, MFR DATE: 2018-09-24, CE, Laser Radiation, STERILE (Gamma Sterilized), Single Use Only Revised Label: Product Label - Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 19-092400-041, USE BY: 2019-12-13, MFR DATE: 2019-10-14, CE 2797, Laser Radiation, STERILE (Gamma Sterilized), Single Use Only Package Label - DABRA 101 5 French, Ref: 1222-5000-01, Lot: LOT: 19-092400-041, USE BY: 2019-12-13, UDI's (01)00842362100031, (17)20191213(21)2019092400041
Reason for recall
The firm has become aware there is a potential problem with its DABRA catheters resulting in higher catheter calibration failure rate due to the product shelf life is currently less than the labeled shelf life.
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-2006-2020. 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.