FDA Medical Device Recalls (openFDA)
Microline Surgical, Inc.: Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips Ref 3221
- Recall number
- Z-1986-2014
- Recalling firm
- Microline Surgical, Inc.
- Product
- Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips Ref 3221
- Status
- Terminated
- Initiated
- 2014-05-12
- Posted
- 2014-07-02
- Terminated
- 2015-08-13
- Reason
- Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw
- Root cause
- Nonconforming Material/Component
- Action
- Microline Surgical notified Distributors, Hospitals (Customers/End Users) and Suppliers via letter dated May 15, 2014 with labeling, pictures, and Recall Response Forms via UPS Overnight Air, email, and/or fax. Product is requested to be returned and a RMA number will be issued. Contact 978-867-1775 for questions.
- Quantity
- 150 units
- Distribution
- Worldwide Distribution-USA including the states of CA, HI, ID, MA, MI, MS, PA, TN, UT, and TX. and the countries of Belgium, France, Ireland, Germany, Indonesia, Korea, Norway, Saudi Arabia, Switzerland, Turkey, and UK.
- Lot, serial or model codes
- Lot Numbers: 00115342
- 510(k) numbers
- ["K981389"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 1000137656
- Firm city
- Beverly
- 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