CLASS II Device recall · Reported 10 Oct 2018 · FDA Enforcement Report
EEA Circular Stapler with Tri-Staple Technology recalled by Covidien
Covidien is recalling EEA Circular Stapler with Tri-Staple Technology, distributed nationwide in the US. The recall was initiated on 17 Aug 2018 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-0070-2019
- FDA event ID
- 81043
- Recalling firm
- Covidien, Mansfield, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Aug 2018
- FDA classified
- 4 Oct 2018
- Reported
- 10 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Surgical Instruments
Timeline
| 17 Aug 2018 | Recall initiated by company | |
| 4 Oct 2018 | Classified by FDA | +48 days |
| 10 Oct 2018 | 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 firm identified the potential for a device to have an incorrect tissue gap. Use of a device with an incorrect tissue gap may result in incomplete staple formation and/or the inability to remove the device from tissue following application potentially leading to bleeding, anastomotic leak or tissue trauma. There have been no reports of serious injury related to this issue.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage: The EEA Circular Stapler with Tri-Staple Technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis.
Where it was distributed
Worldwide Distribution - US Nationwide in the states of CA, FL, IL, NC, NY, UT. and the countries of Austria, Belgium, Denmark, Finland, France, Germany, Iceland, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Reunion, Spain, Sweden, Switzerland, and United Kingdom.
Nationwide CaliforniaFloridaIllinoisNorth CarolinaNew YorkUtah
Questions about this recall
Is EEA Circular Stapler with Tri-Staple Technology recalled?
Yes. Covidien recalled EEA Circular Stapler with Tri-Staple Technology on 17 Aug 2018. The recall is Class II and its status is Terminated. Recall number Z-0070-2019.
Why was it recalled?
The firm identified the potential for a device to have an incorrect tissue gap. Use of a device with an incorrect tissue gap may result in incomplete staple formation and/or the inability to remove the device from tissue following application potentially leading to bleeding, anastomotic leak or tissue trauma. There have been no reports of serious injury related to this issue.
Which lots are affected?
P8A0976X P8A0977X P8A0978X P8A0979X P8A0980X P8A0981X P8B1538X P8B1539X P8B1540X P8B1541X P8B1542X P8C0032X P8C0033X P8C1177X P8C1178X P8C1179X P8C1180X P8C1181X P8C1183X P8D1405X P8D1406X P8D1407X P8D1408X P8D1409X P8D1410X P8D1411X P8E1211X P8E1212X P8E1213X P8E1214X P8E1215X P8E1216X P8E1217X P8E1304X P8E1305X
Where was it sold?
Worldwide Distribution - US Nationwide in the states of CA, FL, IL, NC, NY, UT. and the countries of Austria, Belgium, Denmark, Finland, France, Germany, Iceland, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Reunion, Spain, Sweden, Switzerland, and United Kingdom.
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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