FDA Medical Device Recalls (openFDA)
Becton Dickinson and Company: BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
- Recall number
- Z-0022-2009
- Recalling firm
- Becton Dickinson and Company
- Product
- BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
- Status
- Terminated
- Initiated
- 2008-09-15
- Posted
- 2008-10-03
- Terminated
- 2012-02-29
- Reason
- Product labeled as 4 mm High Viscosity Injector tip contains a 6 mm tip.
- Root cause
- Employee error
- Action
- BD contacted accounts by telephone on 9/15/08 requesting users to discard units and complete the response form. Contact Becton Dickinson and Co. at 1-781-906-7950 for assistance.
- Quantity
- 1485 units
- Distribution
- AZ, CA, CO, IL, OH, FL, PA , TN, TX,and VA Foreign: Australia and Japan.
- Lot, serial or model codes
- Lot Number: 8018591
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HMX
- Firm FEI
- 1211998
- Firm city
- Waltham
- Firm state
- MA
- 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