FDA Medical Device Recalls (openFDA)
Stryker Communications: Stryker Visum 300 Ceiling-mounted Exam Light.
- Recall number
- Z-1992-2013
- Recalling firm
- Stryker Communications
- Product
- Stryker Visum 300 Ceiling-mounted Exam Light.
- Status
- Terminated
- Initiated
- 2013-07-25
- Posted
- 2013-08-21
- Terminated
- 2015-04-03
- Reason
- Potential incomplete final weld on the drop tube flange.
- Root cause
- Process control
- Action
- The firm decided to recall and notified consignees with an "Urgent Medical Device Correction/Removal" notification letter dated 07/29/13. The product issue was described and recommended actions were provided. Customers may contact Stryker Technical Support at 866-841-5663.
- Quantity
- 1,375 units
- Distribution
- Worldwide Distribution: US natiowide and to the country of Canada.
- Lot, serial or model codes
- Product sold under the following part numbers: 0682001410A, 0682001410B, 0682001410C, 0682001410D, 0682001410E, 0682001410F, 0682001410G, and 0682001410H and shipped prior to February 28, 2013.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KZF
- Firm FEI
- 3002975342
- Firm city
- Flower Mound
- Firm state
- TX
- 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