Instratek Recalls Endotrig Trigger Release Blades Due to Cannula Advancement Issues
Instratek is recalling 235 Endotrig Trigger Release Sterile Micro Hook Blades because they could not be advanced into the cannula during procedures.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a functional defect (inability to advance the blade) without reporting any injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving low-risk issues or voluntary precautionary actions.
Plain-English summary
Instratek, Incorporated is recalling 235 units of the Endotrig Trigger Release Sterile Micro Hook Blade, Model number 1052. The affected lots are M674180, MAKL170, and M674200. These blades are intended to release the A-1 pulley in endoscopic trigger release procedures.
The recall was initiated after Instratek received multiple complaints that the blades could not be advanced into the cannula through which they are used during the procedures. The products were distributed nationwide in the United States, including the states of Arizona, Michigan, Nebraska, Nevada, and Texas.
Healthcare providers and consumers should stop using the affected blades and contact Instratek for further instructions or a return.
The recalled product
- Product
- Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended to release A-1 pulley in endoscopic trigger release procedures.
- Manufacturer
- Instratek, Incorporated
- Hazard
- Affected units
- 235
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 (4)
- Model number 1052
- Lots M674180
- MAKL170
- M674200
Distribution
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