Covidien Trocar Recall Due to Potential Seal Disengagement with Mesh
Covidien recalls 44,777 Auto Suture Blunt Tip Trocars worldwide due to potential seal disengagement when mesh products are used incorrectly with the device.
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: FDA Class II classification without reported hospitalizations or injuries. The recall addresses a potential risk of device malfunction when used incorrectly with mesh products, fitting the criterion for High severity.
Plain-English summary
Covidien, LP is recalling 44,777 units of the Auto Suture Blunt Tip Trocar (Product Number OMS-T12BTNL). The device was distributed worldwide, including throughout the United States and internationally.
The recall is due to the potential for trocar seal disengagement when mesh products are used incorrectly with the device. If the trocar seal disengages, the device may not function properly during surgical use.
Affected units carry product number OMS-T12BTNL and include multiple lot and serial numbers. The UDI/DI numbers are 20884521552446 and 10884521552449. A complete list of affected lot numbers is available in the FDA recall notice.
Healthcare providers and surgical teams with this device should consult the FDA recall notice (Z-1471-2024) for detailed instructions regarding the affected lots and any necessary follow-up actions.
The recalled product
- Product
- Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNL
- Manufacturer
- Covidien, LP
- Hazard
- Affected units
- 44,777
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-T12BTNL
- UDI/DI: 20884521552446
- 10884521552449
- Lot Serial Number: P0L1444
- P0L1444
- P0M1932
- P1A1491
- P1B0649
- P1B1560
- P1D0399
- P1G0142
- P1G1132
- P1G1365
- P1J1046
- P1J1179
- P1J1213
- P1L0002
- P1M0637
- P1M0838
- P2A0608
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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Same hazard · seal disengagement
See all →- HighCovidien Auto Suture Blunt Tip Trocar Seal Disengagement Recall
FDA (Devices) · 2024-04-10
- HighCovidien Auto Suture blunt tip trocar recalled for seal disengagement
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- HighCovidien Auto Suture Trocar Recall: Potential Seal Disengagement With Incorrect Mesh Use
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- HighCovidien Auto Suture Trocar Recalled for Potential Seal Disengagement
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