Covidien Auto Suture blunt tip trocar recalled for seal disengagement
Covidien recalls its Auto Suture blunt tip trocar (OMS-T10BTS) due to potential seal disengagement when mesh products are used incorrectly, affecting approximately 18,048 units worldwide.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall with no reported deaths, injuries, or hospitalizations. The hazard represents a risk-of-harm scenario (seal disengagement during mesh use) where injury has not yet been reported, meeting the criteria for severity score 3 per the rubric.
Plain-English summary
Covidien, LP is recalling the Auto Suture® Blunt Tip Trocar, Product Number OMS-T10BTS, due to potential seal disengagement when mesh products are used incorrectly with the device.
The recall affects approximately 18,048 units that have been distributed worldwide, including to the United States and numerous other countries across Europe, Asia, the Middle East, Africa, and the Americas. The affected product is identified by UDI/DI codes 20884521081076 and 10884521081079.
Healthcare facilities and surgical centers using this device should review the safety information and contact Covidien directly for guidance on device use or replacement options.
The recalled product
- Product
- Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS
- Manufacturer
- Covidien, LP
- Hazard
- Affected units
- 18,048
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Product Number/CFN: OMS-T10BTS
- UDI/DI: 20884521081076
- 10884521081079
- Lot Serial Number: P1D1416
- P1E1509
- P1F1547
- P1H0898
- P1J0874
- P1J0895
- P1J1268
- P1J1340
- P1J1341
- P1K0181
- P1L0683
- P1L0978
- P1L0984
- P2A0017
- P2A0018
- P2A0019
- P2A0020
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Covidien, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
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See all →- HighCovidien Trocar Recall Due to Potential Seal Disengagement with Mesh
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- HighCovidien Auto Suture Blunt Tip Trocar Seal Disengagement Recall
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