FDA Medical Device Recalls (openFDA)
EBI, L.P.: EBI VueCath Endoscopic Spinal System
- Recall number
- Z-1006-03
- Recalling firm
- EBI, L.P.
- Product
- EBI VueCath Endoscopic Spinal System
- Status
- Terminated
- Initiated
- 2003-06-17
- Posted
- 2003-07-15
- Terminated
- 2003-12-31
- Reason
- Non sterile device is labeled sterile.
- Root cause
- Labeling False and Misleading
- Action
- The firm notified their customers via a field correction letter dated June 17, 2003. Instructions given are to sterilize the unit prior to use. A EBI field representative will be visiting to replace the boxes.
- Quantity
- 39
- Distribution
- Hospitals, clinics, and doctors nationwide.
- Lot, serial or model codes
- Catalog Number: S002 Lot/Serial Nos: F10021, F10017, F10012, F10018, F10025, F10019, F10020, F10014, F10023, F10022, F10001, F10000, F10024, F10007, F10008, F00005, F10003, F10016, F10015, F10002, F10027.
- 510(k) numbers
- ["K023233","K971083","K982484","K010179"]
- PMA numbers
- not on file
- Product code
- GWG
- Firm FEI
- 2242816
- Firm city
- Parsippany
- Firm state
- NJ
- 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