Integra Jarit Take-Apart Endoscopic Instruments Recalled for Component Defect
Integra Limited is recalling 108 Take-Apart Endoscopic Instruments because internal shaft components were out of specification.
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. The source text does not report any injuries, illnesses, or deaths, and the defect is a manufacturing specification issue rather than a high-risk pathogen or structural failure with reported harm.
Plain-English summary
Integra Limited is recalling 108 units of Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments. These instruments are intended for use in laparoscopic gynecological surgery and other operative procedures under endoscopic observations, specifically for grasping, dissecting, or manipulating soft tissue.
The recall was initiated because the instrument shafts were released with internal components that were out of specification. The affected units include specific model numbers (643350, 643425, 643650, and 643725) and associated batch numbers listed in the agency's structured data.
The products were distributed nationwide in the United States, including the states of Arizona, California, Illinois, Massachusetts, Minnesota, New Jersey, Oklahoma, Tennessee, Texas, Virginia, Washington, and Wisconsin. Healthcare facilities and users should stop using the affected instruments and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments. Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments are intended for use in laparoscopic gynecological surgery and other operative procedures under endoscopic observations. For use when a rigid endoscopic instrument…
- Manufacturer
- Integra Limited
- Hazard
- Affected units
- 108
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 (19)
- Model number 643350 -- batch numbers 1045878
- 1045879
- 1045881
- 1045880
- 1045872
- 1045882
- 1045876
- 1045877
- 1045873
- 1045874
- and 1045875. Model number 643425 -- batch numbers 1045890
- 1045886
- 1045884
- 1045887
- 1045888
- 1045889
- and 1045885. Model number 643650 -- batch numbers 1045891
- 1045892
- and 1045893. Model number 643725 -- batch numbers 1045894 and 1045895.
Distribution
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