Z-1469-2024Class II

Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS

Name: Z-1469-2024 Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS
Creator: Covidien, LP
Published: 2024-02-28
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2024-02-28 / Open, Classified / root cause: labeling and UDI

FDA source

Covidien, LP began a recall of Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS on 2024-02-28. FDA classified it as Class II and gives the reason as "The potential for trocar seal disengagement when using mesh products incorrectly with the device". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1469-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-28
Posted: 2024-04-03
Recalling firm: Medtronic, Inc.
Product: Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: The potential for trocar seal disengagement when using mesh products incorrectly with the device.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: On February 28, 2024, the firm notified customers of the issue via URGENT: MEDICAL DEVICE RECALL letters. Actions to be taken by the customer: 1. Inform all surgeons and clinicians who handle the preparation and/ or placement of a Mesh Device that utilize the balloon and blunt tip trocar devices. 2. Prior to using any Mesh device in conjunction with the following Trocars: Covidien Auto Suture" Structural Balloon Trocar and Auto Suture" Blunt Tip Trocar, please carefully review and adhere to the mesh manufacturer s Instructions for Use (IFU) on proper insertion techniques. 3. Please complete and return the customer confirmation form enclosed with this letter acknowledging receipt of this information via email to [email protected]. 4. Please transfer this notice to other organizations on which this action has an impact and maintain a copy of this notice in your records. Adverse events or quality problems experienced with this product should be reported to the FDA and Medtronic: Online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm, or call FDA at 1-800-FDA-1088 (1-800-332-1088) and Medtronic Vascular Customer Service at 800-716-6700. We regret any inconvenience this may cause. We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this communication, please contact your Medtronic Representative.
Quantity in commerce: 18,048 units
Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Aruba, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Gibraltar, Greece, Guadeloupe, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Republic Of, Luxembourg, Macao, Malaysia, Malta, Martinique, Mayotte, Mexico, Netherlands, New Caledonia, New Zealand, Nigeria, Northern Ireland, Norway, Oman, Poland, Portugal, Puerto Rico, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Turkey, United Arab Emirates, United Kingdom, United States, Uzbekistan, Viet Nam, Virgin Islands, U.S.;
Product codes and lots: Product Number/CFN: OMS-T10BTS; UDI/DI: 20884521081076, 10884521081079; Lot Serial Number: P1D1416, P1E1509, P1F1547, P1H0898, P1J0874, P1J0895, P1J0895, P1J1268, P1J1268, P1J1340, P1J1340, P1J1341, P1K0181, P1L0683, P1L0978, P1L0984, P1L0984, P2A0017, P2A0017, P2A0018, P2A0019, P2A0019, P2A0020, P2A0021, P2A0021, P2A0750, P2A0750, P2B0135, P2B0136, P2B0136, P2B0752, P2B0916, P2C0757, P2D0347, P2D0541, P2D0542, P2F0385, P2F0386, P2F0386, P2H0022, P2H0022, P2H0147, P2H0147, P2K0433, P2K0433, P2K0434, P2K0434, P3D0123, P3D0123, P3D0124, P3D0124, P3E0187, P3E0187, P3E0188, P3E0189, P3E0189, P3H1197, P3J0771, P3J0858, P3K1341;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1469-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1465-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-10	2024-04-03
Z-1466-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-10	2024-04-03
Z-1467-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-10	2024-04-03
Z-1468-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-10	2024-04-03
Z-1469-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-10	2024-04-03
Z-1470-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-10	2024-04-03
Z-1471-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-10	2024-04-03

Product code GCJ

K924011Class IIOrigin Blunt Tip Surgical TrocarOrigin Medsystems, Inc. / cleared 1993-07-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)