# FDA recall Z-2643-2020

> **Wellspect HealthCare (Division of DENTSPLY IH AB)** · Class II · device recall initiated 2020-06-17.

## 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.

## Distribution

AL, AZ, CA, CT, FL, GA, IL, IN, KY, MA, MD, MI, MO, NC, NH, NJ, OH, PA, RI, SC, TX, VA and Australia, Brazil, Canada, European Union, China, South Korea, Kuwait, New Zeeland, Singapore, United Kingdom

## Key facts

- **Recall number:** Z-2643-2020
- **Recalling firm:** Wellspect HealthCare (Division of DENTSPLY IH AB)
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-06-17
- **Report date:** 2020-07-29
- **Termination date:** 2021-04-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Molndal, N/A, Sweden

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2643-2020

## Citation

> AI Analytics. FDA recall Z-2643-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2643-2020. Source: US FDA. Licensed CC0.

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