Z-0954-04

The product is a sheath meant to fit over a Nasopharyngoscope and is labeled as EndoScrub 2 Sheaths

Name: Z-0954-04 The product is a sheath meant to fit over a Nasopharyngoscope and is labeled as EndoScrub 2 Sheaths
Creator: Medtronic Xomed, Inc.
Published: 2004-01-29
License: https://open.fda.gov/license/

Medtronic Xomed, Inc. / initiated 2004-01-29 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Xomed, Inc. began a recall of The product is a sheath meant to fit over a Nasopharyngoscope and is labeled as EndoScrub 2 Sheaths on 2004-01-29. The reason FDA records is "The sheaths in question have shafts that are one inch longer than required for the endoscope specified on the label". 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-0954-04
Status: Terminated
Initiated: 2004-01-29
Posted: 2004-07-20
Terminated: 2012-05-03
Recalling firm: Medtronic Xomed, Inc.
Product: The product is a sheath meant to fit over a Nasopharyngoscope and is labeled as EndoScrub 2 Sheaths
Product code: FED Endoscopic Access Overtube, Gastroenterology-Urology
Reason for recall: The sheaths in question have shafts that are one inch longer than required for the endoscope specified on the label.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: A Recall notification letter was mailed to each hospital account on January 29, 2004 for each type of device they received which was under recall explaining the error and asking the accounts to remove recalled product from inventory, fax them the response sheet and to return the products.
Quantity in commerce: 7 boxes, 5 sheaths per box
Distribution: Products were distributed to 23 hospitals and surgical centers in NC, NB, IN, UT, TX, NY, WI, MO, TN, ID, OK, FL, MA, WY, NJ, LA.
Product codes and lots: Lots 31396400 and 30722300

Product code FED

K982594Class IIEndo-Scrub/endo-Scrub 2Xomed, Inc. / cleared 1998-08-27

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)