Wellspect HealthCare (Division of DENTSPLY IH AB): Medical Device Recall in 2020 - (Recall #: Z-2643-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

LoFric Origo, Nelaton, 16in, FR10 urinary catheters

Product Classification:

Class II

Date Initiated: June 17, 2020

Date Posted: July 29, 2020

Recall Number: Z-2643-2020

Event ID: 85905

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.

Status: Terminated

Product Quantity: N/A

Code Information:

Lot # 447123

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated