FDA Medical Device Recalls (openFDA)
Vital Signs Colorado Inc.: Light Wand Orotracheal Lighted Stylet, Part number: 3910. Sterile, Vital Signs Colorado Inc., Englewood, CO. , packaged 20 per case.
- Recall number
- Z-2454-2008
- Recalling firm
- Vital Signs Colorado Inc.
- Product
- Light Wand Orotracheal Lighted Stylet, Part number: 3910. Sterile, Vital Signs Colorado Inc., Englewood, CO. , packaged 20 per case.
- Status
- Terminated
- Initiated
- 2008-08-11
- Posted
- 2008-09-21
- Terminated
- 2011-01-10
- Reason
- Light protector may detach from lighted stylet during intubation.
- Root cause
- Device Design
- Action
- Consignees were notified by letter on 08/11/2008, and instructed to return any unopened and sealed product for replacement.
- Quantity
- 55,560 pieces
- Distribution
- Worldwide including states of CA, OH, MD, NC, TX and VA facilities in GA, IN, MS, NC, NJ, NM, NY, and VA. Foreign distribution to Argentina, Australia, Canada, Chile, China, Colombia, Dominican Republic, Dubai, Ecuador, Egypt, Germany, Hong Kong, India, Indonesia, Israel, Italy, Korea, Malaysia, Mexico, Nepal, Netherlands, New Zealand, Philippines, Qatar, Republic of China, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Thailand, UK, and Venezuela.
- Lot, serial or model codes
- Lot numbers: 1188D, 1465D, 1683D, 1999D, 2165D, 2461D, 2635D, 2833D, 2856D, 3044E, 3072F, 3129D, 3355H, 3612F, 3673D, 4377F, 5495C, 5496C, 5497C, 5498C, 5668C, 5669C, 6581C, 6582C, 6730C, 7108C, 7256C, 7364C, 7861C, 7970C, 8355C, 8880C, 9233C, 9423C, 9905C, 3854F, 3945G, 3966F, 4013E, 4036N, 4078D, 4103U, 4156M, 4211K, 4222P, 4222R, 4266G, 4281C, 4294J, 4306G, 4318D, 4331A, 4339R, 4358P, 4366X.
- 510(k) numbers
- ["K944729"]
- PMA numbers
- not on file
- Product code
- BSR
- Firm FEI
- 1718887
- Firm city
- Englewood
- Firm state
- CO
- 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