Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0986-2024 — 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

U.S. FDA — Device Enforcement · United States · 2023-11-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0986-2024
Date of alert
2023-11-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Covidien LP
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
20884523006527
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.