Wellspect HealthCare (Division of DENTSPLY IH AB) Aminogatan 1 Molndal Sweden LoFric Origo, Nelaton, 16in, FR10 urinary catheters Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
LoFric Origo, Nelaton, 16in, FR10 urinary catheters
Brand
Wellspect HealthCare (Division of DENTSPLY IH AB) Aminogatan 1 Molndal Sweden
Lot Codes / Batch Numbers
Lot # 447123
Products Sold
Lot # 447123
Wellspect HealthCare (Division of DENTSPLY IH AB) Aminogatan 1 Molndal Sweden is recalling LoFric Origo, Nelaton, 16in, FR10 urinary catheters due to Wellspect Healthcare is voluntarily recalling certain LoFric Origo" urethral catheters due to a potential defect which may be present in the catheter . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Effected catheters must be not used and should be immediately returned. Wellspect issued an urgent medical device field notice dated June 19, 2020 to customers.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, CA, CT, FL, GA, IL, IN, KY, MD, MA, MI, MO, NH, NJ, NC, OH, PA, RI, SC, TX, VA
Page updated: Jan 10, 2026