Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

LoFric Origo Recalled by Wellspect HealthCare (Division of DENTSPLY IH AB) Due to Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo"...

Date: June 17, 2020
Company: Wellspect HealthCare (Division of DENTSPLY IH AB)
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Wellspect HealthCare (Division of DENTSPLY IH AB) directly.

Affected Products

LoFric Origo, Nelaton, 16in, FR10 urinary catheters

Quantity: N/A

Why Was This 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.

Where Was This Sold?

This product was distributed to 22 states: AL, AZ, CA, CT, FL, GA, IL, IN, KY, MD, MA, MI, MO, NH, NJ, NC, OH, PA, RI, SC, TX, VA

Affected (22 states)Not affected

About Wellspect HealthCare (Division of DENTSPLY IH AB)

Wellspect HealthCare (Division of DENTSPLY IH AB) has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report