FDA Medical Device Recalls (openFDA)
Covidien LP: AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material to soft tissue in minimally invasive and open surgical hernia repair procedures Model ABSTACK30
- Recall number
- Z-0986-2024
- Recalling firm
- Covidien LP
- Product
- AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material to soft tissue in minimally invasive and open surgical hernia repair procedures Model ABSTACK30
- Status
- Open, Classified
- Initiated
- 2023-11-16
- Posted
- 2024-02-06
- Terminated
- not on file
- Reason
- Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentially resulting in a sterile/moisture barrier breach, compromising the product sterility
- Root cause
- Process control
- Action
- Medtronic issued Urgent Medical Device Recall Letter and Customer Acknowledgement Form to each consignee via mail beginning 16 November 2023. Letter states reason for recall, health risk and action to take: Identify and quarantine all unused and non-expired affected lot N3J1860Y of the ModelABSTACK30 AbsorbaTack" Absorbable Fixation Device listed above. See attachment A forguidance on identifying potentially affected devices. "Return all unused product from the affected lot in your inventory to Medtronic. Please contactrs.covidienfeedbackcustomerservice@medtronic.com for the Return Good Authorization (RGA). "In addition, please complete and return the enclosed Customer Confirmation Form tors.gmbfcamitg@medtronic.com even if you do not have unused inventory. "Pass on this notice to all those who need to be aware within your organization or to any organization where the potentially affected product has been transferred or distributed. If you have any questions regarding this communication, please contact your Medtronic Representative or Customer Service at 800-962-9888.
- Quantity
- 54 units
- Distribution
- US Nationwide distribution in the states of CA, CO, FL, IL, TX.
- Lot, serial or model codes
- GTIN 20884523006527 Lot number: N3J1860Y
- 510(k) numbers
- ["K090470"]
- PMA numbers
- not on file
- Product code
- OCW
- Firm FEI
- 1219930
- 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