Banyan Medical Pyramidal Trocar Recalled for Potential Sterility Issues
Banyan Medical is recalling 5 x 55mm Pyramidal Trocars due to a potential lack of assurance of sterility. The affected units were distributed in Indiana and Tennessee.
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: The recall involves a risk-of-harm product (sterile medical device) where the hazard is a potential lack of sterility, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Banyan Medical, LLC is recalling 19 boxes of 5 x 55mm Regular Pyramidal Trocars and 2x Cannula (Product Code 400-008). The recall is being conducted because of a potential lack of assurance of sterility for these sterile, single-use laparoscopic instruments.
The affected products are identified by Lot Numbers 140310 and 140806. The recall covers 19 boxes of 5 units each. These products were distributed to facilities in Indiana (IN) and Tennessee (TN).
Consumers and healthcare facilities should stop using the affected trocars and contact Banyan Medical, LLC for further instructions or a return.
The recalled product
- Product
- Banyan Medical 5 x 55mm Regular Pyramidal Trocar and 2x Cannula. For Laproscopic Use- Sterile Single Use Only. Product Code 400-008
- Manufacturer
- Banyan Medical, LLC
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 (2)
- Lot Numbers: 140310
- 140806
Distribution
Part of a larger recall action
This product is one of 2 recalled by Banyan Medical, LLC 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.
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