FDA Medical Device Recalls (openFDA)
Wellspect HealthCare (Division of DENTSPLY IH AB): LoFric Origo, Tiemann, 16in, FR12 urinary catheters
- Recall number
- Z-2644-2020
- Recalling firm
- Wellspect HealthCare (Division of DENTSPLY IH AB)
- Product
- LoFric Origo, Tiemann, 16in, FR12 urinary catheters
- Status
- Terminated
- Initiated
- 2020-06-17
- Posted
- not on file
- Terminated
- 2021-04-09
- Reason
- Wellspect Healthcare is voluntarily recalling certain LoFric Origo" urethral catheters due to a potential defect which may be present in the catheters distal tip.
- Root cause
- Equipment maintenance
- Action
- 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.
- Quantity
- not on file
- Distribution
- 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
- Lot, serial or model codes
- Lot # 450422
- 510(k) numbers
- ["K122078"]
- PMA numbers
- not on file
- Product code
- EZD
- Firm FEI
- 3009632672
- Firm city
- Molndal
- Firm state
- not on file
- Firm country
- Sweden
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28