CLASS II Device recall · Reported 26 Feb 2020 · FDA Enforcement Report
Endo GIA Ultra Universal Stapler-intended for resection recalled
Covidien is recalling Covidien Endo GIA Ultra Universal Stapler-intended for resection, transection in general, distributed nationwide in the US. The recall was initiated on 17 Jan 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-1264-2020
- FDA event ID
- 84811
- Recalling firm
- Covidien, Mansfield, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Jan 2020
- FDA classified
- 18 Feb 2020
- Reported
- 26 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 17 Jan 2020 | Recall initiated by company | |
| 18 Feb 2020 | Classified by FDA | +32 days |
| 26 Feb 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result in a potentially increased risk for infection
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND
Where it was distributed
US Nationwide, Israel, and Japan
Questions about this recall
Is Endo GIA Ultra Universal Stapler-intended for resection, transection in general surgery recalled?
Yes. Covidien recalled Endo GIA Ultra Universal Stapler-intended for resection, transection in general surgery on 17 Jan 2020. The recall is Class II and its status is Terminated. Recall number Z-1264-2020.
Why was it recalled?
Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result in a potentially increased risk for infection
Which lots are affected?
Lot Number: P9E0022Y
Where was it sold?
US Nationwide, Israel, and Japan
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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