Z-0247-04

Smith & Nephew Endocoupler C-Mount 30mm Focal Length Reference: 7204823 and 7204823S (S indicates unit...

Name: Z-0247-04 Smith & Nephew Endocoupler C-Mount 30mm Focal Length Reference: 7204823 and 7204823S (S indicates unit...
Creator: Smith And Nephew, Inc. Endoscopy Division
Published: 2003-10-10
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2003-10-10 / Terminated / root cause: manufacturing process

FDA source

Smith And Nephew, Inc. Endoscopy Division began a recall of Smith & Nephew Endocoupler C-Mount 30mm Focal Length Reference: 7204823 and 7204823S (S indicates unit previously serviced) on 2003-10-10. The reason FDA records is "Hardware of the camera coupler may rust and result in an ineffective sterilization/cleaning process". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0247-04
Status: Terminated
Initiated: 2003-10-10
Posted: 2003-12-18
Terminated: 2016-01-28
Recalling firm: Smith & Nephew, Inc.
Product: Smith & Nephew Endocoupler C-Mount 30mm Focal Length Reference: 7204823 and 7204823S (S indicates unit previously serviced)
Product code: FEM Accessories, Photographic, For Endoscope (Exclude Light Sources)
Reason for recall: Hardware of the camera coupler may rust and result in an ineffective sterilization/cleaning process.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: 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

Product code FEM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)