FDA Device recall Z-2643-2020
LoFric Origo, Nelaton, 16in, FR10 urinary catheters
- FDA Device
- Class II
- terminated
- Published 2020-07-29
On 2020-07-29 the FDA classified a Class II recall of LoFric Origo, Nelaton, 16in, FR10 urinary catheters by Wellspect Healthcare Division Of Dentsply Ih Ab, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2643-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-06-17 |
| Published | 2020-07-29 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Wellspect Healthcare Division Of Dentsply Ih Ab |
| Distribution | AL, AZ, CA, CT, FL, GA, IL, IN, KY, MA, MD, MI, MO, NC, NH, NJ, OH, PA, RI, SC, TX, VA |
Product
LoFric Origo, Nelaton, 16in, FR10 urinary catheters
Reason
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.
Identifiers
| code_info | Lot # 447123 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2643-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.