LoFric Origo — Class II medical device recall Z-2643-2020
Terminated recall by Wellspect HealthCare (Division of DENTSPLY IH AB), reported 2020-07-29, distributed in AL, AZ, CA, CT, FL, GA, IL, IN…. Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo" urethral catheters due to a potential def
| Recall number | Z-2643-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Wellspect HealthCare (Division of DENTSPLY IH AB), Molndal, N/A, Sweden |
| Recall initiated | 2020-06-17 |
| Classified | 2020-07-17 |
| Reported by FDA | 2020-07-29 |
| Terminated | 2021-04-09 |
| Distributed | AL, AZ, CA, CT, FL, GA, IL, IN, KY, MA, MD, MI, MO, NC, NH, NJ, OH, PA, RI, SC, TX, VA |
| Countries outside the US | AU, BR, CA, CN, GB, KR, KW, SG |
| Lot numbers | 447123 |
Product
LoFric Origo, Nelaton, 16in, FR10 urinary catheters
Reason for recall
Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo" urethral catheters due to a potential defect which may be present in the catheter s distal tip.
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-2643-2020. 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.