FDA Medical Device Recalls (openFDA)
Cook Endoscopy: Cook Esophageal Dilator Set --------------------------------------Small label applied by OEM supplier: C CEDS 58 70 * Use By 2008/04 * Lot No. F1734513 * Sterile * Rx only * Cook *** Large product label applied at Cook Endoscopy: Cook Esophageal Dilator Set * Catheter Diameter: 20 FR. Catheter Length: 15cm. * Dilator Diameter: 58 FR. * Dilator Length: 70 CM. * Disposable Single Use Only * Rx Only * 2008/05 * Cook * Wilson Cook Medical GI Endoscopy * 4900 Bethania Station Road, Winston Salem, NC 27105
- Recall number
- Z-0848-06
- Recalling firm
- Cook Endoscopy
- Product
- Cook Esophageal Dilator Set --------------------------------------Small label applied by OEM supplier: C CEDS 58 70 * Use By 2008/04 * Lot No. F1734513 * Sterile * Rx only * Cook *** Large product label applied at Cook Endoscopy: Cook Esophageal Dilator Set * Catheter Diameter: 20 FR. Catheter Length: 15cm. * Dilator Diameter: 58 FR. * Dilator Length: 70 CM. * Disposable Single Use Only * Rx Only * 2008/05 * Cook * Wilson Cook Medical GI Endoscopy * 4900 Bethania Station Road, Winston Salem, NC 27105
- Status
- Terminated
- Initiated
- 2006-04-20
- Posted
- 2006-05-06
- Terminated
- 2006-06-29
- Reason
- Large product label contains an incorrect expiration date.
- Root cause
- Labeling False and Misleading
- Action
- Consignees were notified by letter (USPS certified)on/about April 21, 2006.
- Quantity
- 43 units
- Distribution
- Alabama consignees
- Lot, serial or model codes
- Lot: W2110292, Correct expiration on Small OEM Label: Mar-08, Expiration date on Large Label Apr-08; W2118663, Correct exp.: Mar-08, Exp. On large label: Apr-08; W2126166, Correct exp.: Apr-08, Exp. On large label: May-08; W2128638, Correct exp.: Apr-08, Exp. On large label: May-08; W2128639, Correct exp.: Apr-08, Exp. On large label: May-08; W2138018, Correct exp.: Apr-08, Exp. On large label: May-08; W2143643, Correct exp.: Apr-08, Exp. On large label: May-08; W2150003, Correct exp.: Apr-08, Exp. On large label: May-08; W2177983, Correct exp.: Apr-08, Exp. On large label: May-08; W2190096, Correct exp.: Sep-08, Exp. On large label: Oct-08; W2194318, Correct exp.: Sep-08, Exp. On large label: Oct-08.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KOG
- Firm FEI
- 1037905
- Firm city
- Winston Salem
- Firm state
- NC
- 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