Reported Apr 10, 2024 · Ongoing

Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB

Covidien, LP

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Covidien, LP · 60 Middletown Ave · North Haven, CT · 06473-3908

Is this the product you have?

  • Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB
Lot codes and dates
  • Product Number/CFNOMS-T10SB
  • UDI/DI20884521081083 and 10884521081086
  • Lot Serial Number

    172 of 172 codes

    • P0B1097Y
    • P0L1408
    • P0L1408
    • P0L1442
    • P0L1442
    • P0M1720
    • P0M1721
    • P0M1931
    • P1A1469
    • P1A1469
    • P1A1470
    • P1A1485
    • P1A1486
    • P1A1486
    • P1B1294
    • P1B1294
    • P1B1449
    • P1C0441
    • P1C1565
    • P1C1565
    • P1C1566
    • P1C1568
    • P1C1674
    • P1C1674
    • P1C1675
    • P1C1676
    • P1C1676
    • P1C1786
    • P1C1920
    • P1D0366
    • P1D1379
    • P1D1379
    • P1D1380
    • P1D1380
    • P1D1509
    • P1D1509
    • P1E1551
    • P1F1389
    • P1F1482
    • P1F1482
    • P1F1521
    • P1G0143
    • P1G0143
    • P1K0808
    • P1K0808
    • P1K1036
    • P1K1099
    • P1K1099
    • P1K1320
    • P1L0482
    • P1L0482
    • P1L0486
    • P1L0486
    • P1L0679
    • P1L0679
    • P1L0680
    • P1L0680
    • P1L0885
    • P1L0885
    • P1L1108
Amount recalled
124,863 units

This recall covers 9 products

The agency filed one notice per product. You are reading one of them; the other 8 are below.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

The potential for trocar seal disengagement when using mesh products incorrectly with the device.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:20 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.