LoFric Origo — Class II medical device recall Z-2644-2020
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-2644-2020 |
|---|---|
| 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 | 450422 |
Product
LoFric Origo, Tiemann, 16in, FR12 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 catheters 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-2644-2020. 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.