FDA Medical Device Recalls (openFDA)
Steris Corp: C1141 Flexible Endoscope Processing Container, designed to fit the Steris System I Processor. The unit may be sold individually or with the processing tray assembly (C1140).
- Recall number
- Z-0829-03
- Recalling firm
- Steris Corp
- Product
- C1141 Flexible Endoscope Processing Container, designed to fit the Steris System I Processor. The unit may be sold individually or with the processing tray assembly (C1140).
- Status
- Terminated
- Initiated
- 2003-04-23
- Posted
- 2003-05-15
- Terminated
- 2004-02-05
- Reason
- The container flow port is inverted, which restricts the flow of sterilant to the endoscope and affects the sterilization process.
- Root cause
- Other
- Action
- The firm notified their customers by telephone and letter on 4/23/2003.
- Quantity
- 138 units
- Distribution
- The product was shipped to end-users located nationwide and worldwide.
- Lot, serial or model codes
- All codes.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MLR
- Firm FEI
- 1527821
- Firm city
- Mentor
- Firm state
- OH
- Firm country
- not on file
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