CLASS II Device recall · Reported 29 Jul 2020 · FDA Enforcement Report
LoFric Origo, Nelaton, FR10 urinary catheters recalled
Wellspect HealthCare (Division of Dentsply IH AB) is recalling LoFric Origo, Nelaton, FR10 urinary catheters, distributed in 22 states. The recall was initiated on 17 Jun 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2643-2020
- FDA event ID
- 85905
- Recalling firm
- Wellspect HealthCare (Division of Dentsply IH AB), Molndal, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Jun 2020
- FDA classified
- 17 Jul 2020
- Reported
- 29 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 17 Jun 2020 | Recall initiated by company | |
| 17 Jul 2020 | Classified by FDA | +30 days |
| 29 Jul 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
LoFric Origo, Nelaton, 16in, FR10 urinary catheters
Where it was distributed
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
AlabamaArizonaCaliforniaConnecticutFloridaGeorgiaIllinoisIndianaKentuckyMassachusettsMarylandMichiganMissouriNorth CarolinaNew HampshireNew JerseyOhioPennsylvaniaRhode IslandSouth Carolina
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot # 447123
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 85905This product is part of a recall event; the main page for the event is LoFric Origo, Tiemann, FR12 urinary catheters recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | LoFric Origo, Tiemann, FR12 urinary catheters recalled | Wellspect HealthCare (Division of Dentsply IH AB) | Device Malfunction | 22 states | |
| CLASS II | LoFric Origo, Tiemann, FR14 urinary catheters recalled | Wellspect HealthCare (Division of Dentsply IH AB) | Device Malfunction | 22 states |
More recalls from Wellspect HealthCare (Division of Dentsply IH AB)
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | LoFric Origo, Tiemann, FR14 urinary catheters recalled | Wellspect HealthCare (Division of Dentsply IH AB) | Device Malfunction | 22 states |
| Device | CLASS II | LoFric Origo, Tiemann, FR12 urinary catheters recalled | Wellspect HealthCare (Division of Dentsply IH AB) | Device Malfunction | 22 states |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |