FDA Medical Device Recalls (openFDA)
Symbiosis Corp.: Boston Scientific Microvasive Radial Jaw 3 Single-Use Maximum Capacity Biopsy Forceps Needle, 240 cm length, 3.3 mm Jaw Outside Diameter. Each device is pakaged in a Tyvek laminate pouch. The pouch assemblies are packaged in a five-pack product box.
- Recall number
- Z-0562-03
- Recalling firm
- Symbiosis Corp.
- Product
- Boston Scientific Microvasive Radial Jaw 3 Single-Use Maximum Capacity Biopsy Forceps Needle, 240 cm length, 3.3 mm Jaw Outside Diameter. Each device is pakaged in a Tyvek laminate pouch. The pouch assemblies are packaged in a five-pack product box.
- Status
- Terminated
- Initiated
- 2002-09-03
- Posted
- 2003-02-21
- Terminated
- 2008-04-15
- Reason
- Product does not have the needle component as part of the jaw assembly.
- Root cause
- Other
- Action
- The firm forwarded recall letters and response forms via Federal Express to Risk Managers at hospitals on 9/3/2002. Accounts were asked to return product by first calling 1-800-862-1284.
- Quantity
- 155/5-pack
- Distribution
- Product was distributed to 29 hospital accounts nationwide. There were no intenational, govenment or military accounts.
- Lot, serial or model codes
- The code for the individual pouches is Catalog 1589 and Lot # 0551847, expiration date of 2005-07. The code for the five pack boxes is Catalog No. 1589 and lot number 0551847, expiration date of 2005-07.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 1051710
- Firm city
- Miami
- 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