AbsorbaTack recallZ-0986-2024 · Covidien LP · initiated Nov 16, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Covidien LP or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Process control
What the company is doing
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 [email protected] for the Return Good Authorization (RGA). "In addition, please complete and return the enclosed Customer Confirmation Form [email protected] 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.
Recall details
- Recall number
- Z-0986-2024
- Status
- Open, Classified
- Initiated by the company
- Nov 16, 2023
- Posted by the FDA
- Feb 6, 2024
- Recalling firm
- Covidien LP
- Quantity
- 54 units
- Product code
- OCW
- FDA submissions
- K090470
- Distribution
- US Nationwide distribution in the states of CA, CO, FL, IL, TX.
Product description
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
Code information (models, lots, serial numbers)
GTIN 20884523006527 Lot number: N3J1860Y
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- AbsorbaTack ABSTACK30Covidien LP · STAPLE, IMPLANTABLE1 recall455 reports
Product lines
Other devices under the same FDA submission
5 devices cleared under K090470 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- ProTack 174006Covidien LP · Endoscopic tissue approximation device709 reports
- Stat Tack OMS-TTSSCovidien LP · STAPLE, IMPLANTABLE12 reports
- Tacker OMS-TTSDCovidien LP · STAPLE, IMPLANTABLE3 reports
- Tacker OMS-TTSD30Covidien LP · STAPLE, IMPLANTABLE3 reports
- Tacker OMS-TTHCovidien LP · STAPLE, IMPLANTABLE1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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