Aesculap Bipolar Generator Foot Pedal Recalled for Energy Failure
Aesculap, Inc. is recalling 59 Bipolar Generator Foot Pedals because the bipolar energy did not stop after the pedal was released.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the failure of a medical device to stop energy delivery during surgery poses a significant risk of injury, meeting the criteria for a Severe rating.
Plain-English summary
Aesculap, Inc. is recalling 59 units of the Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226. This device is used for electrosurgical cutting and coagulation. The recall was initiated because the bipolar energy did not stop after the release of the foot pedal.
The affected units were distributed nationwide in the United States, including the states of AR, CA, FL, IN, IA, KS, MD, MN, MO, OR, TN, TX, VA, and WA. The specific units involved have manufacture dates between 45/10 and 31/12, which are indicated on the label on the bottom of the foot pedal.
Healthcare facilities and users should stop using the affected foot pedals and contact Aesculap, Inc. for further instructions regarding the recall.
The recalled product
- Product
- Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226, for electrosurgical cutting and coagulation.
- Manufacturer
- Aesculap, Inc.
- Affected units
- 59
Distribution
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