FDA Medical Device Recalls (openFDA)
Linvatec Corp. dba ConMed Linvatec: ***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source
- Recall number
- Z-2455-2012
- Recalling firm
- Linvatec Corp. dba ConMed Linvatec
- Product
- ***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source
- Status
- Terminated
- Initiated
- 2011-05-20
- Posted
- 2012-09-25
- Terminated
- 2012-09-26
- Reason
- Linvatec Corporation dba ConMed Linvatec, Largo, FL initiated a recall of their products LS7700 Xenon Universal Light Source and LS7600 Xenon Light Source are intended to be used with an endoscope to provide illumination during endoscopic procedures.
- Root cause
- Nonconforming Material/Component
- Action
- Linvatec Corporation sent an "URGENT Medical Device Recall Notification letter dated May 20, 2011 to its customers via FedEx service. Firm advised their suppliers of the Light Sources potentially has unapproved components and does not meet the finished product requirement. The distributors and end user level are advised if any affected product is in their possession can be used until returned for advance exchange. The customers were instructed to: 1) locate the identified product by serial number at your facility and complete the Reply Form attached; 2) Contact ConMed Linvatec Customer Service (800-237-0169) to receive SR Number Advance Exchange affected product only. Once Customer Service authorizes the SR Number your Advance Exchange Light Source will be shipped to your facility; 3) Once replacement unit is received, utilize the packaging material to return the recalled Light Source to ConMed Linvatec using the enclosed FedEx Airway Bill. Mail or FAX copy of Reply Form to ConMed Linvatec; 4) Complete and return a copy of the Reply Form. For questions contact your local ConMed Linvatec office or email Custseryl@linvatec.com, Customer Service at 800-237-0169 or fax to 727-319-5701.
- Quantity
- 1
- Distribution
- Worldwide Distribution - US Nationwide and the countries of Canada, DK, HK, IN, IT, KR, MY, RU, CO, VN, ZA.
- Lot, serial or model codes
- GCT
- 510(k) numbers
- ["K070376"]
- PMA numbers
- not on file
- Product code
- GCT
- Firm FEI
- 1017294
- Firm city
- Largo
- 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