FDA Medical Device Recalls (openFDA)
Richard Wolf GmbH: RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endoscopic microsurgery.
- Recall number
- Z-1868-2018
- Recalling firm
- Richard Wolf GmbH
- Product
- RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endoscopic microsurgery.
- Status
- Terminated
- Initiated
- 2018-03-11
- Posted
- not on file
- Terminated
- 2022-03-09
- Reason
- Tube ends may be mixed up.
- Root cause
- Use error
- Action
- The firm initiated the recall via an Urgent Safety Information letter on 03/11/2018. The letter identified the affected product and the problem involved. Customers were asked to check the inventory for the affected lot numbers and complete the attached answer form. The firm requested that the recalled product be discarded. All users should be notified of the safety information. The completed answer form should be returned via fax to 07043 354467 or e-mail to marek.rast@richard-wolf.com.
- Quantity
- 1710 units
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- Lot numbers: 32062417, 32133317
- 510(k) numbers
- ["K000180"]
- PMA numbers
- not on file
- Product code
- HIF
- Firm FEI
- 3002808001
- Firm city
- Knittlingen
- Firm state
- not on file
- Firm country
- Germany
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