FDA Medical Device Recalls (openFDA)
Covidien Llc: Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - Product Usage: designed for the repair of inguinal hernias via laparoscopic or posterior open procedures Item Code: TECT1510AL
- Recall number
- Z-1142-2021
- Recalling firm
- Covidien Llc
- Product
- Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - Product Usage: designed for the repair of inguinal hernias via laparoscopic or posterior open procedures Item Code: TECT1510AL
- Status
- Terminated
- Initiated
- 2021-01-13
- Posted
- not on file
- Terminated
- 2023-02-14
- Reason
- incorrect device is contained in the package. The packaging label indicates that the device is for left side use, the product inside the package is for right side use. Use of an opposite side mesh can result in implant failure and hernia recurrence
- Root cause
- Under Investigation by firm
- Action
- Medtronic issued Urgent Medical Device Recall letter via Federal Express and/or certified mail beginning January 13, 2021. The letter states reason for recall, health risk and action to take:: " Immediately quarantine and discontinue use of the affected item codes and lots. " Return affected product. " Forward the information to anyone who they have distributed affected Covidien Parietex" Hydrophilic Anatomical Mesh. " Complete the Recalled Product Return Form. Inventory within Medtronic control and customer returned products will be scrapped. Questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.
- Quantity
- 129 units WW
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of MA and the countries of France, French Guiana, Germany, Luxembourg, Spain, United Kingdom.
- Lot, serial or model codes
- Lot Number: SUH0709M
- 510(k) numbers
- ["K173796"]
- PMA numbers
- not on file
- Product code
- FTL
- 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