CLASS II ONGOING Device recall · Reported 7 Oct 2020 · FDA Enforcement Report
Endo GIA Auto Suture Universal Articulating Loading Unit recalled
Covidien is recalling Endo GIA Auto Suture Universal Articulating Loading Unit, distributed nationwide in the US. The recall was initiated on 12 Aug 2020 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-0004-2021
- FDA event ID
- 86214
- Recalling firm
- Covidien, North Haven, CT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Aug 2020
- FDA classified
- 1 Oct 2020
- Reported
- 7 Oct 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 12 Aug 2020 | Recall initiated by company | |
| 1 Oct 2020 | Classified by FDA | +50 days |
| 7 Oct 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Where it was distributed
Worldwide distribution - US Nationwide and Global Distribution.
Stores named: Walmart
Questions about this recall
Is Endo GIA Auto Suture Universal Articulating Loading Unit recalled?
Yes. Covidien recalled Endo GIA Auto Suture Universal Articulating Loading Unit on 12 Aug 2020. The recall is Class II and its status is Ongoing. Recall number Z-0004-2021.
Why was it recalled?
The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.
Which lots are affected?
Lot Numbers: T7F017X T7J023X T7L032X T7L034X T8L100X T7F025X T7J024X T7L033X T7L035X T9F138X T7F026X T7K020X
Where was it sold?
Worldwide distribution - US Nationwide and Global Distribution.
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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