AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5… — Class II medical device recall Z-0986-2024
Ongoing recall by Covidien LP, reported 2024-02-14, distributed nationwide. Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentially resulting
| Recall number | Z-0986-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LP, Mansfield, MA, United States |
| Recall initiated | 2023-11-16 |
| Classified | 2024-02-06 |
| Reported by FDA | 2024-02-14 |
| Distributed | Nationwide (US) |
| Quantity | 54 units |
| Reason classes | potency, sterility, packaging |
| UPC / GTIN / UDI-DI | 20884523006527 |
| Lot numbers | N3J1860Y |
| Model numbers | ABSTACK30 |
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
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0986-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.