Z-0441-06

SGD-12-70 Savary-Gilliard Dilator - Diameter: 12MM./36 FR. Length: 70 CM Reusable

Name: Z-0441-06 SGD-12-70 Savary-Gilliard Dilator - Diameter: 12MM./36 FR. Length: 70 CM Reusable
Creator: Cook Endoscopy
Published: 2006-01-05
License: https://open.fda.gov/license/

Wilson-Cook Medical Inc. / initiated 2006-01-05 / Terminated / root cause: labeling and UDI

FDA source

Cook Endoscopy began a recall of SGD-12-70 Savary-Gilliard Dilator - Diameter: 12MM./36 FR. Length: 70 CM Reusable on 2006-01-05. The reason FDA records is "The dilator size does not match the label on the product and product packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0441-06
Status: Terminated
Initiated: 2006-01-05
Posted: 2006-01-25
Terminated: 2006-04-04
Recalling firm: Wilson-Cook Medical Inc.
Product: SGD-12-70 Savary-Gilliard Dilator - Diameter: 12MM./36 FR. Length: 70 CM Reusable
Product code: KNQ Dilator, Esophageal
Reason for recall: The dilator size does not match the label on the product and product packaging.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: A recall letter was issued to the consignees on 1/5/06 requesting return of the product. The letter also requested a sub-recall if the product had been further distributed.
Distribution: Canada and Australia
Product codes and lots: Lot W2048624

Product code KNQ

K851955Class IISavary-Gilliard DilatorWilson-Cook Medical, Inc. / cleared 1985-07-25

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)