FDA Medical Device Recalls (openFDA)
COVIDIEN LLC: Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo Grasp" Auto Suture" grasper 5 mm instrument has applications in a variety of gynecologic, general, urologic, thoracic and endoscopic procedures for temporary grasping/clamping of tissue and small tubular structures.
- Recall number
- Z-1212-2019
- Recalling firm
- COVIDIEN LLC
- Product
- Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo Grasp" Auto Suture" grasper 5 mm instrument has applications in a variety of gynecologic, general, urologic, thoracic and endoscopic procedures for temporary grasping/clamping of tissue and small tubular structures.
- Status
- Terminated
- Initiated
- 2019-03-13
- Posted
- not on file
- Terminated
- 2020-04-23
- Reason
- Sterilization method used was not consistent with the labeling and the approved sterilization method
- Root cause
- Process control
- Action
- Medtronic notified consignees via an "URGENT MEDICAL DEVICE RECALL" letter by Federal Express and/or certified mail on March 13, 2019. The letter informs customers of the recall of twenty-one production lot of Covidien Endo Clinch" and Endo Grasp" Auto Suture" graspers 5mm as the sterilization method used for these lots was not consistent with the labeling and the approved sterilization method. Customers are instructed to take the following actions: 1. Please immediately quarantine and discontinue use of the affected item codes and lots listed above. 2. Please return affected product as indicated below. 3. If you have distributed the Endo Clinch" II or Endo Grasp" Auto Suture" graspers 5mm listed above, please promptly forward the information from this letter to those recipients. 4. Complete the Recalled Product Return Form even if you do not have inventory. -----If you have inventory email to: feedback.customerservice@covidien.com fax to: 800-895-6140. -----Exception: Customers with zero inventory, fax to 203-492-7719 or email to GMBFCAMITG@Medtronic.com If purchased by distributor, fax to 203-492-7719 or email GMBFCAMITG@Medtronic.com. If you have any questions or concerns, please do not hesitate to contact your Medtronic representative or Customer Service at 800-962-9888, option 2.
- Quantity
- 240 units
- Distribution
- Worldwide Distribution: US (Nationwide) and to countries of: Canada, Chile, Costa Rica, Guatemala, Japan, Mexico, Panama, Slovakia, Spain, Switzerland and Turkey.
- Lot, serial or model codes
- Lot Numbers: P8D1335PRX P8D1336PRX P8D1605PRX
- 510(k) numbers
- ["K903205"]
- PMA numbers
- not on file
- Product code
- HDA
- Firm FEI
- 1282497
- Firm city
- Mansfield
- 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