Food, drugs, devices › Covidien, LP
Device recall: Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB
FDA enforcement event 94131 is a device recall by Covidien, LP of North Haven, CT, initiated 28 Feb 2024 and classified Class II, with 7 product records.
FDA defines Class II as 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. 87% of the 970 device enforcement events initiated in 2024 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Covidien, LP has 31 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Covidien, LP, North Haven, CT.
Reason for recall
"The potential for trocar seal disengagement when using mesh products incorrectly with the device."
Distribution
"Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Aruba, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Colombia, Croatia, Czech Republic,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1465-2024 | Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB | 124,863 units | Class II | Ongoing | 10 Apr 2024 |
| Z-1466-2024 | Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL | 315,716 units | Class II | Ongoing | 10 Apr 2024 |
| Z-1467-2024 | Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNL | 11,796 units | Class II | Ongoing | 10 Apr 2024 |
| Z-1468-2024 | Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT | 93,673 units | Class II | Ongoing | 10 Apr 2024 |
| Z-1469-2024 | Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS | 18,048 units | Class II | Ongoing | 10 Apr 2024 |
| Z-1470-2024 | Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT | 165,356 units | Class II | Ongoing | 10 Apr 2024 |
| Z-1471-2024 | Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNL | 44,777 units | Class II | Ongoing | 10 Apr 2024 |
Context
Other enforcement events for Covidien, LP
All 31 events for Covidien, LP
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The potential for trocar seal disengagement when using mesh products incorrectly with the device."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Aruba, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Colombia, Croatia, Czech Republic,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.