Encision, Inc.
United StatesFDA applicant, unverified FDA FEI 1000117361
Encision, Inc. is a medical device manufacturer, with 237 devices listed in FDA GUDID and FDA 510(k) (FDA Class II) and 26 FDA recalls as of 14 Nov 2026.
- Devices
- 237
- Registrations
- FDA
- FDA recalls
- 26
Registry facts
- Registries
- FDA GUDID 227
- FDA 510(k) 10
- Device classes
- FDA Class II 237
- FDA recalls
- Identifiers
- FDA FEI 1000117361
- DUNS 612250175
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
What Encision, Inc. makes
Encision, Inc. makes a range of medical devices, including endoscopic electrosurgical electrodes, rigid endoscopic tissue manipulation forceps, electrosurgical handpieces, and electrical-only medical device connection cables. These products are designed for use in surgical procedures, with examples including disposable electrodes, grasping forceps, and scissors. The company's devices are used for tasks such as tissue manipulation and electrosurgery.
The company's portfolio is regulated as Class II devices and is listed in the FDA's 510(k) and UDI registries.
Catalogue
Search and filter all 237 devicesShowing 1-50 of 237
Company details
- FDA FEI number
- 1000117361
- DUNS number
- 612250175
- Address
- 6797 WINCHESTER CIR., BOULDER, CO, 80301
FDA recalls
FDA recall records list 26 recalls initiated by ENCISION, INC., the earliest on 2003-01-15 and the most recent on 2012-06-15. By recorded status: 26 terminated. The reasons filed fall into these groups: sterility or contamination, packaging, electrical or power and mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2012
- 15 Jun 2012 Z-1951-2012 Class II Terminated Encision is performing a field correction to their AEM Disposable Electrodes due to two consumer complaints reporting unanticipated alarms from the AEM monitor while using the device. This issue could result delays or complications during surgical procedures.
2011
- 24 Aug 2011 Z-3093-2011 Unclassified (pre-2012) Terminated Electrode tips have been reported breaking off during use or cleaning.
- 24 Aug 2011 Z-3094-2011 Unclassified (pre-2012) Terminated Electrode tips have been reported breaking off during use or cleaning.
- 24 Aug 2011 Z-3095-2011 Unclassified (pre-2012) Terminated Electrode tips have been reported breaking off during use or cleaning.
- 24 Aug 2011 Z-3096-2011 Unclassified (pre-2012) Terminated Electrode tips have been reported breaking off during use or cleaning.
- 24 Aug 2011 Z-3097-2011 Unclassified (pre-2012) Terminated Electrode tips have been reported breaking off during use or cleaning.
- 7 Apr 2011 Z-2395-2011 Unclassified (pre-2012) Terminated Sterility may be compromised due to holes in packaging.
- 7 Apr 2011 Z-2396-2011 Unclassified (pre-2012) Terminated Sterility may be compromised due to holes in packaging.
- 7 Apr 2011 Z-2397-2011 Unclassified (pre-2012) Terminated Sterility may be compromised due to holes in packaging.
- 7 Apr 2011 Z-2398-2011 Unclassified (pre-2012) Terminated Sterility may be compromised due to holes in packaging.
Show the 25 most recent of 26 recalls
2011
- 7 Apr 2011 Z-2399-2011 Unclassified (pre-2012) Terminated Sterility may be compromised due to holes in packaging.
- 7 Apr 2011 Z-2400-2011 Unclassified (pre-2012) Terminated Sterility may be compromised due to holes in packaging.
2010
- 5 Apr 2010 Z-1539-2010 Unclassified (pre-2012) Terminated Electrosurgical electrode tip insulation may crack and break off during use.
Full distribution text
- 5 Apr 2010 Z-1540-2010 Unclassified (pre-2012) Terminated Electrosurgical electrode tip insulation may crack and break off during use.
Full distribution text
- 5 Apr 2010 Z-1541-2010 Unclassified (pre-2012) Terminated Electrosurgical electrode tip insulation may crack and break off during use.
Full distribution text
- 5 Apr 2010 Z-1542-2010 Unclassified (pre-2012) Terminated Electrosurgical electrode tip insulation may crack and break off during use.
Full distribution text
- 5 Apr 2010 Z-1543-2010 Unclassified (pre-2012) Terminated Electrosurgical electrode tip insulation may crack and break off during use.
Full distribution text
- 5 Apr 2010 Z-1544-2010 Unclassified (pre-2012) Terminated Electrosurgical electrode tip insulation may crack and break off during use.
Full distribution text
- 5 Apr 2010 Z-1545-2010 Unclassified (pre-2012) Terminated Electrosurgical electrode tip insulation may crack and break off during use.
Full distribution text
- 5 Apr 2010 Z-1546-2010 Unclassified (pre-2012) Terminated Electrosurgical electrode tip insulation may crack and break off during use.
Full distribution text
- 5 Apr 2010 Z-1539-2010 Unclassified (pre-2012) Terminated Electrosurgical electrode tip insulation may crack and break off during use.
2004
- 9 Jul 2004 Z-1132-04 Unclassified (pre-2012) Terminated Firm found pinholes in packaging which would compromise sterility.
Full distribution text
- 11 Jun 2004 Z-1074-04 Unclassified (pre-2012) Terminated Electrosurgical tip may break or come off during use.
- 9 Jul 2004 Z-1132-04 Unclassified (pre-2012) Terminated Firm found pinholes in packaging which would compromise sterility.
2003
- 23 Jun 2003 Z-1050-03 Unclassified (pre-2012) Terminated Use of NC versions of AEM monitor presents burn hazard when used with single pad and capacitively coupled patient return electrodes.
- 23 Jun 2003 Z-1051-03 Unclassified (pre-2012) Terminated Use of NC versions of AEM monitor presents burn hazard when used with single pad and capacitively coupled patient return electrodes.
- 23 Jun 2003 Z-1052-03 Unclassified (pre-2012) Terminated Use of NC versions of AEM monitor presents burn hazard when used with single pad and capacitively coupled patient return electrodes.
Frequently asked questions
How many devices does ENCISION, INC. have in the registry?
The registry currently lists 237 devices for ENCISION, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list ENCISION, INC.'s devices?
Among its 50 most recently registered devices, ENCISION, INC. has devices listed in FDA GUDID (50 devices).
What risk classes do ENCISION, INC.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for ENCISION, INC.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for ENCISION, INC.?
FDA recall records list 26 recalls initiated by ENCISION, INC., the most recent initiated on 15 Jun 2012. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from ENCISION, INC. in the registry?
The most recently registered devices listed for ENCISION, INC. include AEM® Disposable Electrode, Spatula ES0301, Fenestrated Bowel Grasper, 45cm, 20mm Jaw EP3690-45RR, AEM® Disposable Electrode, J-Hook ES0310 and Fixed Tip Electrode, 90 degree, L-Hook ES3513B.