Device recall: EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
Class II FDA enforcement event 82950. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Covidien LLC started this device recall on 17 May 2019. The firm address in the FDA record is in North Haven, CT. FDA put the recall in Class II. FDA event 82950 has 12 product records. The first FDA enforcement report date is 26 Jun 2019. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide domestic distribution, worldwide foreign distribution.
Recalling firm
Covidien LLC, North Haven, CT.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
12 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1825-2019 | EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT | 3,113,280 | Class II | Ongoing | 26 Jun 2019 |
| Z-1826-2019 | EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT | 3,113,280 | Class II | Ongoing | 26 Jun 2019 |
| Z-1827-2019 | EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT | 3,113,280 | Class II | Ongoing | 26 Jun 2019 |
| Z-1828-2019 | EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT | 3,113,280 | Class II | Ongoing | 26 Jun 2019 |
| Z-1829-2019 | EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT | 3,113,280 | Class II | Ongoing | 26 Jun 2019 |
| Z-1830-2019 | EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT | 3,113,280 | Class II | Ongoing | 26 Jun 2019 |
| Z-1831-2019 | EGIA45 CT AR MD THK REL, EGIA45CTAMT | 3,113,280 | Class II | Ongoing | 26 Jun 2019 |
| Z-1832-2019 | SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT | 3,113,280 | Class II | Ongoing | 26 Jun 2019 |
| Z-1833-2019 | SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT | 3,113,280 | Class II | Ongoing | 26 Jun 2019 |
| Z-1834-2019 | SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT | 3,113,280 | Class II | Ongoing | 26 Jun 2019 |
| Z-1835-2019 | SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT | 3,113,280 | Class II | Ongoing | 26 Jun 2019 |
| Z-1836-2019 | SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT | 3,113,280 | Class II | Ongoing | 26 Jun 2019 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2019
- 968
- Share of these events in Class II
- 88%
- Product records in this event
- 12Median of the firm: 1
- Events of the firm on the register
- 77
Other events of the firm
Official channels
- FDA enforcement report Z-1825-2019The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 82950. https://recallregister.com/fda/ii/82950/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide domestic distribution, worldwide foreign distribution.
- What quantity of product is in FDA event 82950?
- The event has 12 product records. The first record gives this quantity:
3,113,280
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2019 have the same class?
- 88% of the 968 device events that started in 2019 are in Class II.