Encision Recalls AEM Disposable Electrodes Due to Unanticipated Alarms
Encision, Inc. is recalling 48 boxes of AEM Disposable Electrodes after two complaints reported unanticipated alarms from the AEM monitor, which could cause delays or complications during surgery.
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 medical device where a defect could result in complications during surgical procedures, fitting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Encision, Inc. is performing a field correction for 48 boxes of AEM Disposable Electrodes, model FC03XX series. These electrosurgical accessories are intended for the ablation, removal, resection, and coagulation of soft tissue in open, endoscopic, and laparoscopic surgical procedures. The affected units are identified by the following lot codes: RDB, RJB, RJE, RJH, RLG, RLI, RLJ, RLK, RLO, RLP, RLR, RLQ, SBF, and SBJ.
The recall was initiated due to two consumer complaints reporting unanticipated alarms from the AEM monitor while using the device. The source text notes that this issue could result in delays or complications during surgical procedures. The affected products were distributed worldwide, including in the United States (California, Texas, Georgia, New York, North Carolina, and Ohio) and New Zealand.
Healthcare facilities and consumers should stop using the affected AEM Disposable Electrodes immediately. Encision, Inc. is the recalling firm responsible for the field correction. Users should contact the manufacturer for further instructions on how to return or replace the devices.
The recalled product
- Product
- AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical…
- Manufacturer
- Encision, Inc.
- Affected units
- 48
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 (14)
- RDB
- RJB
- RJE
- RJH
- RLG
- RLI
- RLJ
- RLK
- RLO
- RLP
- RLR
- RLQ
- SBF
- SBJ.
Distribution
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