FDA Medical Device Recalls (openFDA)
Medtronic Xomed, Inc.: The product is a sheath meant to fit over a Nasopharyngoscope and is labeled as EndoScrub 2 Sheaths
- Recall number
- Z-0954-04
- Recalling firm
- Medtronic Xomed, Inc.
- Product
- The product is a sheath meant to fit over a Nasopharyngoscope and is labeled as EndoScrub 2 Sheaths
- Status
- Terminated
- Initiated
- 2004-01-29
- Posted
- 2004-07-20
- Terminated
- 2012-05-03
- Reason
- The sheaths in question have shafts that are one inch longer than required for the endoscope specified on the label.
- 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
- 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.
- Lot, serial or model codes
- Lots 31396400 and 30722300
- 510(k) numbers
- ["K982594"]
- PMA numbers
- not on file
- Product code
- FED
- Firm FEI
- 1045254
- Firm city
- Jacksonville
- Firm state
- FL
- 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