CLASS II ONGOING Device recall · Reported 5 Jun 2024 · FDA Enforcement Report
Tri-Staple 2.0 Black Reinforced Intelligent Reload recalled by Covidien
Covidien is recalling Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, distributed nationwide in the US. The recall was initiated on 15 Apr 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1891-2024
- FDA event ID
- 94484
- Recalling firm
- Covidien, North Haven, CT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Apr 2024
- FDA classified
- 24 May 2024
- Reported
- 5 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 15 Apr 2024 | Recall initiated by company | |
| 24 May 2024 | Classified by FDA | +39 days |
| 5 Jun 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery
Product as listed by the FDA
Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis Model: SIGTRSB60AXT
Where it was distributed
Worldwide - US Nationwide distribution in the state of NJ and the countries of Australia, Japan, New Zealand, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand.
Questions about this recall
Why was it recalled?
Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery
Which lots are affected?
GTIN: 10884521717633 20884521717630 Lot #: N3G1372Y
Where was it sold?
Worldwide - US Nationwide distribution in the state of NJ and the countries of Australia, Japan, New Zealand, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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