Integra MicroFrance Electrosurgical Instruments Recalled for Burn and Shock Risks
Integra LifeSciences is recalling 30,146 MicroFrance electrosurgical instruments due to reports of unintended patient or operator burns and electric shock.
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 (electrosurgical instruments) where injury (burns and electric shock) has been reported, but the source text does not specify the severity of these injuries or mention hospitalizations, aligning with the 'High' severity criteria for reported injuries without explicit severe outcomes.
Plain-English summary
Integra LifeSciences Corp. is recalling 30,146 units of Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments. The recall was initiated due to reports of unintended patient or operator burns and operator electric shock associated with the use of these devices.
The affected instruments were distributed to facilities in Arizona, California, Colorado, Florida, Indiana, Kentucky, Massachusetts, Michigan, North Carolina, New Jersey, New York, New Mexico, Ohio, Tennessee, Texas, Washington, and Wisconsin. The recall covers all batch numbers distributed from January 2011 to February 17, 2016, across a wide range of catalogue numbers.
Healthcare providers and facilities should stop using the affected instruments immediately and contact Integra LifeSciences Corp. for instructions on returning the devices. Patients who have undergone procedures using these instruments should consult their healthcare provider if they experience any adverse effects.
The recalled product
- Product
- Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 30,146
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)
- Catalogue No's: CEV649B5
- CEV649BGP
- CEV649GP
- CEV8649B5
- CEV8649BGP
- CEV646B5
- CEV647B5
- CEV648B5
- CEV649-5B
- CEV649-5N
- CEV8646B5
- CEV8647B5
- CEV8648B5
- CEV1019-5B
- CEV10195C
- CEV10195D
- CEV1019-5N
- CEV10195NA
- CEV10195R
- CEV1039-5-B
Distribution
Part of a larger recall action
This product is one of 2 recalled by Integra LifeSciences Corp. 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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