Integra Jarit Monopolar Cable Recall for Updated Safety Warnings
Integra LifeSciences is recalling 22,500 Jarit Monopolar Cables to distribute an addendum to the Instructions for Use. The update emphasizes existing warnings and adds new precautions for electrosurgical equipment.
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 a Class II recall involving an update to safety warnings and precautions without reported injuries or illnesses, fitting the criteria for moderate severity as a precautionary labeling/documentation update.
Plain-English summary
Integra LifeSciences Corp. is recalling 22,500 units of the Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). This device is used in endoscopic surgery for grasping and dissecting soft tissue, utilizing monopolar electrosurgical current for coagulation and cutting. The recall covers all lots distributed since 2004 and includes worldwide distribution, specifically noting USA Nationwide and Canada.
The recall is initiated to distribute an addendum to the Instructions for Use (IFU). This addendum emphasizes the warnings and precautions already contained in the device's IFU and provides additional warnings and precautions applicable to the use of electrosurgical equipment in health care facility environments. The source text does not report any specific injuries, illnesses, or deaths associated with the device.
Healthcare facilities and users of the Integra(R) Jarit(R) Monopolar Cable should review the provided addendum to ensure they are aware of the updated safety information. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). For use in endoscopic surgery. For use when a rigid endoscopic instrument for grasping and/or dissecting if soft tissue is determined to be appropriate by the surgeon. Monopolar electrosurgical current can be…
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 22,500
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 (1)
- Catalogue No. 600-290. All lots distributed since 2004.
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Integra LifeSciences Corp.
See all →- HighAURORA Surgiscope System Obturator May Break or Separate
FDA (Devices) · 2025-03-12
- HighMediHoney Gel Wound Dressing Recall: Potential Induction Seal Defect
FDA (Devices) · 2025-02-19
- ModerateIntegra implantable hydrocephalus valve recalled for incorrect product description on labels
FDA (Devices) · 2025-01-29
- ModerateCODMAN CERTAS Plus programmable valve recalled for incorrect label descriptions
FDA (Devices) · 2025-01-29
- ModerateProgrammable Valve Device Recalled Due to Incorrect Product Description Labels
FDA (Devices) · 2025-01-29
Same hazard · electrical burn
See all →- HighStryker Neptune SafeAir Electrosurgical Pencil Recalled for Unintended Activation Risk
FDA (Devices) · 2024-11-20
- HighStryker Neptune SafeAir Smoke Evacuation Pencil May Activate Unintentionally
FDA (Devices) · 2024-11-20
- HighStryker smoke evacuation pencil recall: unintended activation risk
FDA (Devices) · 2024-11-20
- HighStryker Neptune SafeAir smoke evacuation pencil recalled for unintended activation
FDA (Devices) · 2024-11-20
- HighProCuity Hospital Beds: Missing electrical safety tests pose burn and shock risk
FDA (Devices) · 2023-12-13
Similar recalls
- ModerateIntegra Jarit Take-Apart Endoscopic Instruments Recalled for Component Defect
FDA (Devices) · 2012-07-25
- HighIntegra MicroFrance Electrosurgical Instruments Recalled for Burn and Shock Risks
FDA (Devices) · 2016-06-08
- HighIntegra Jarit GEMINI CLAMP Recalled Due to Potential Instrument Breakage
FDA (Devices) · 2019-09-11
- SevereIntuitive Surgical Recalls Monopolar Curved Scissors Due to Thermal Injury Risk
FDA (Devices) · 2013-06-12
- HighIntuitive Surgical Monopolar Curved Scissors Recalled for Frayed Grip Cables
FDA (Devices) · 2025-01-22
- ModerateInstrumed Reusable Laparoscopic Instruments Recalled for Updated Safety Warnings
FDA (Devices) · 2014-10-08