FDA Medical Device Recalls (openFDA)
Smith And Nephew, Inc. Endoscopy Division: Smith & Nephew Endocoupler C-Mount 30mm Focal Length Reference: 7204823 and 7204823S (S indicates unit previously serviced)
- Recall number
- Z-0247-04
- Recalling firm
- Smith And Nephew, Inc. Endoscopy Division
- Product
- Smith & Nephew Endocoupler C-Mount 30mm Focal Length Reference: 7204823 and 7204823S (S indicates unit previously serviced)
- Status
- Terminated
- Initiated
- 2003-10-10
- Posted
- 2003-12-18
- Terminated
- 2016-01-28
- Reason
- Hardware of the camera coupler may rust and result in an ineffective sterilization/cleaning process.
- Root cause
- Nonconforming Material/Component
- Action
- Smith & Nephew notified direct accounts by letter on 10/15/03. Service representatives will remove and replace product.
- Quantity
- 35 units
- Distribution
- Nationwide to hospitals Foreign: Australia, Africa, Belgium, Canada, China, Dubai, Egypt, Germany, D\Godmanchester, Italy, Japan, Korea, Malaysia, Norway, Portugal, Singapore, South Africa, Thailand, Taiwan.
- Lot, serial or model codes
- Part Number: 7204823, Camera Coupler, C-Mount, 30mm F.L. Serial Numbers (SR prefix): 8632 8646 8652 8659 8670 8679 8693 8709 8714 8633 8647 8655 8660 8675 8686 8694 8711 8716 8635 8648 8657 8665 8676 8687 8712 8727 8636 8649 8658 8668 8677 8691 8707 8713 8728 Part Number: 7204823S, Camera Coupler, C-Mount, 30mm F.L. Serial Number SR8705
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FEM
- Firm FEI
- 3003604053
- Firm city
- Andover
- Firm state
- MA
- 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