Essential NEO, Audio/Visual Integration Unit An audio/visual integration unit.
FDA Device Recall #Z-2039-2014 — Class II — June 25, 2014
Recall Summary
| Recall Number | Z-2039-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 25, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Karl Storz Endoscopy |
| Location | El Segundo, CA |
| Product Type | Devices |
| Quantity | 968 units |
Product Description
Essential NEO, Audio/Visual Integration Unit An audio/visual integration unit.
Reason for Recall
KARL STORZ Endoscopy-America is recalling the Essential NEO because the connected power cable could potentially become overheated and result in smoke being generated and the cessation of function of the peripheral that the cable is connected to.
Distribution Pattern
Nationwide Distribution including the states of: AL, AZ, CA, CO, CT, District of Columbia, DE, FL, GA, HI, IA, IL, IN, KY, LA, MX, MS, MD, MI, MA, MO, MN. NM, NV, NJ, NY, NC, NE, OK, OH, PA, SC, SD, TX, UT, VA, WI and WA., and Internationally to Canada.
Lot / Code Information
Serial Numbers: 20110322-01 HLS-20110706-01 HLS-20110315-03 MLS-20101208-01 MLS-20101101-01 MLS-20130418-22 MLS-20130715-03 MLS-20130514-06 MLS-20130514-13 MLS-20130514-14 MLS-20130514-09 MLS-20130514-18 MLS-20130514-19 MLS-20130514-16 MLS-20130514-11 MLS-20130514-08 MLS-20130514-15 MLS-20130514-17 HLS-20130523-02 HLS-20130523-04 MLS-20130514-07 HLS-20130523-03 MLS-20130715-04 MLS-20130514-12 MLS-20130514-10 MLS-20110609-01 MLS-20110603-02 MLS-20110603-01 MLS-20110527-02 MLS-20110531-01 MLS-20110531-02 MLS-20110601-01 MLS-20110601-03 MLS-20140411-01 MLS-20130418-18 MLS-20130418-13 HLS16-20130128-04 HLS16-20130128-03 HLS16-20130128-01 HLS16-20130128-02 MLS-20140424-02 MLS-20130514-02 MLS-20130418-21 MLS-20120924-03 LLS-20111003-03 MLS-20111011-03 MLS-20110920-03 MLS-20120117-14 MLS-20120523-03 MLS-20120905-02 LLS-20121112-04 MLS-20130322-01 MLS-20120713-05 MLS-20110713-04 MLS-20110629-01 MLS16-20131028-01 MLS-20120208-01 HLS24-20130823-01 LLS-20120103-03 MLS-20111005-08 HLS-20120118-03 HLS-20120112-01 MLS-20120910-05 MLS-20121010-01 MLS-20120910-03 MLS-20120910-01 MLS-20120830-01 MLS-20120920-03 MLS-20120920-05 MLS-20120920-06 MLS-20120920-07 MLS-20120808-01 MLS-20121010-02 MLS-20121008-02 MLS16-20130708-06 MLS-20120207-04 LLS-20130109-01 MLS-20120213-02 MLS-20120213-03 MLS-20120215-01 MLS-20120215-03 MLS-20120306-02 MLS-20120329-01 HLS-20120207-01 MLS-20120301-01 MLS-20120319-01 MLS-20120313-01 MLS-20120104-03 LLS-20120430-02 MLS-20120511-02 MLS-20120523-02 MLS-20120618-01 MLS-20120301-02 LLS-20120615-01 LLS8-20121024-01 MLS-20120703-07 MLS16-20130927-01 MLS-20121231-01 MLS-20130418-01 MLS-20130405-01 MLS-20130405-10 MLS-20130405-08 20110314-02 HLS24-20130923-01 MLS16-20130923-03 LLS8-20140523-01 HLS24-20130923-02 HLS24-20130826-01 MLS16-20130823-01 LLS8-20130726-04 HLS24-20130809-01 LLS-20120103-12 LLS-20111207-03 LLS-20120103-04 LLS-20111227-02 MLS-20121231-07 MLS-20130418-09 LLS-20120427-03 20110211-01 MLS-20130418-08 MLS-20130418-15 LLS-20110315-01 LLS-20110309-01 HLS24-20130923-03 HLS32-20131206-01 LLS-20120517-05 LLS-20140307-01 LLS-20120419-01 LLS-20120409-01 LLS-20120404-01 LLS-20140307-02 MLS-20110502-03 20110309-02 MLS-20110502-02 MLS-20110506-01 MLS-20110510-02 MLS16-20140328-01 LLS8-20140314-01 MLS-20130726-03 MLS-20130726-02 MLS-20130418-11 MLS-20130418-14 MLS-20130725-01 MLS-20130726-04 MLS-20130726-01 MLS-20130725-02 LLS-20120420-05 MLS-20120523-04 LLS-20120427-05 MLS-20120703-12 MLS-20120703-10 MLS-20120703-09 MLS-20120703-06 MLS-20120703-04 MLS-20120703-03 MLS-20120703-02 MLS-20120703-01 MLS-20120629-01 20110308-01 20110208-01 20110405-06 20110405-04 20110405-02 MLS16-20130214-04 MLS16-20130329-01 MLS16-20130329-04 MLS16-20130214-01 MLS16-20140428-01 MLS16-20130329-03 MLS16-20130923-01 MLS16-20131028-02 20110217-06 MLS-20111011-04 20110217-01 HLS16-20121108-01 HLS16-20121108-07 MLS-20111212-01 MLS-20120501-01 MLS-20120813-04 MLS-20120326-01 MLS-20120306-01 MLS-20120227-01 MLS-20120403-01 MLS-20120419-01 MLS-20120713-04 MLS-20120713-06 MLS-20120713-07 MLS-20120904-02 MLS-20120813-02 MLS-20120716-01 MLS-20120813-01 HLS32-20130401-01 MLS-20111027-02 HLS24-20140407-02 HLS-20130313-02 HLS32-20130906-01 HLS32-20130906-02 MLS-20130329-01 HLS24-20140328-01 HLS24-20140124-02 HLS24-20140203-01 MLS-20130322-02 MLS-20121213-21 MLS-20130405-02 MLS-20130405-04 MLS-20130418-10 MLS-20130418-03 MLS-20130418-20 MLS-20130418-19 MLS-20130514-05 MLS-20130514-04 HLS24-20140213-01 HLS24-20140124-01 MLS-20120904-01 MLS-20130226-01 20110315-04 MLS-20110927-02 MLS-20110510-03 MLS16-20131018-01 HLS24-20130703-01 MLS-20110630-01 MLS16-20130729-01 LLS8-20131016-05 MLS16-20130923-02 HLS24-20130729-01 MLS-20121016-02 MLS-20121016-01 LLS-20110713-05 MLS-20110713-03 MLS-20110622-04 LLS-20110411-04 LLS-20120224-01 LLS-20120116-07 LLS-20110331-01 LLS-20111013-03 LLS-20120307-02 MLS-20110517-01 MLS-20110517-03 20110221-01 MLS-20110517-02 MLS-20110425-01 MLS-20121107-08 MLS-20121207-01 MLS-20120501-02 MLS-20120910-04 MLS-20120914-07 MLS-20120921-01 MLS-20120910-07 LLS8-20130929-01 MLS-20110811-02 20110316-01 LLS-20120802-01 LLS-20120319-02 MLS-20131021-01 HLS24-20131208-01 MLS16-20140127-01 MLS16-20140218-02 HLS16-20130401-13 HLS-20131014-01 20101209-01 HLS16-20130401-03 HLS16-20130401-08 HLS16-20130401-04 HLS16-20130401-07 HLS16-20130401-05 HLS16-20130401-11 HLS16-20130401-09 HLS16-20130401-14 HLS16-20130401-15 HLS16-20130401-10 HLS16-20130401-02 HLS16-20130401-06 HLS16-20130401-01 LLS-20111207-04 MLS-20120116-02 MLS-20130514-03 MLS-20140124-03 MLS-20130715-08 20110301-01 20110307-01 MLS-20130819-02 MLS-20121119-01 LLS-20120313-02 MLS16-20140221-01 LLS-20120420-01 LLS-20120411-05 MLS-20120323-01 LLS-20120615-02 LLS-20120402-04 MLS16-20140221-02 LLS-20111110-03 LLS-20111110-02 MLS-20130819-07 HLS-20121113-03 HLS-20111213-02 HLS-20130523-01 HLS-20120319-03 MLS-20120914-06 MLS-20120910-06 HLS-20121119-06 MLS-20110527-01 MLS16-20131212-01 MLS-20111011-01 MLS-20111011-02 MLS-20121107-17 MLS-20121213-02 MLS-20121107-07 MLS-20121107-11 20110117-02 LLS-20131121-01 LLS-20120517-02 MLS-20131211-01 LLS-20130205-03 MLS-20131002-01 MLS-20131127-01 MLS-20131118-01 MLS-20130514-20 HLS-20131127-01 HLS24-20130531-01 HLS-20131209-02 LLS8-20140210-04 LLS8-20140211-01 LLS8-20140211-02 LLS8-20140210-01 LLS8-20140210-03 LLS8-20140210-05 LLS8-20140210-02 MLS-20121115-02 HLS24-20130411-01 HLS-20121012-01 LLS8-20131104-06 MLS-20111013-07 LLS8-20131016-04 20110211-02 LLS8-20131122-01 MLS-20120806-01 MLS-20120716-02 MLS-20111013-06 MLS-20120118-01 MLS-20120723-03 MLS-20120703-08 MLS-20120723-02 MLS-20111027-03 MLS-20120111-02 MLS-20120124-02 MLS-20120117-02 MLS-20120713-09 LLS8-20121122-02 LLS8-20121122-01 LLS8-20140228-01 MLS-20111227-01 20110321-05 MLS-20130916-02 HLS-20130227-04 HLS-20130110-01 HLS-20121227-02 20110315-05 20110321-03 20110301-02 LLS-20120116-04 MLS-20121107-04 HLS-20121113-02 HLS-20131209-01 LLS-20110803-04 LLS-20111118-07 LLS-20120427-01 LLS-20120802-02 LLS-20120517-03 MLS16-20130926-01 LLS8-20130812-01 MLS-20120515-01 MLS-20130109-02 MLS-20121119-04 MLS-20121107-03 MLS-20130109-03 MLS-20130109-04 MLS-20121213-11 MLS-20121213-13 MLS-20121213-15 MLS-20121213-10 MLS-20121213-09 MLS-20121213-08 MLS-20121213-07 MLS-20121213-03 MLS-20121213-14 MLS-20121213-17 MLS-20121213-18 MLS-20121231-04 MLS-20121213-19 MLS-20121231-02 MLS-20121227-01 MLS-20121213-20 MLS-20121213-06 LLS-20111020-03 LLS-20111109-01 MLS-20110616-03 MLS-20110603-03 MLS-20110613-03 MLS-20110622-03 MLS-20110622-01 MLS-20110616-04 MLS-20110616-02 MLS-20110616-01 MLS-20110613-04 MLS-20110613-02 MLS-20110613-01 MLS-20110608-01 MLS-20120203-01 MLS-20120713-03 MLS-20120920-02 MLS-20120924-01 MLS-20120830-02 MLS-20121008-01 MLS-20120924-05 MLS-20120924-04 MLS-20120910-02 MLS-20120924-02 MLS-20130514-22 MLS16-20131230-02 MLS16-20140120-01 MLS16-20140131-02 MLS16-20140120-02 MLS-20130405-07 MLS-20130715-05 MLS-20130715-07 MLS-20130715-06 MLS16-20130503-01 LLS8-20130503-04 MLS16-20130503-02 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LLS-20120301-03 LLS-20120302-02 LLS-20120327-01 HLS-20111202-03 HLS-20120116-01 20110211-03 MLS-20130514-01 MLS-20130405-03 MLS-20130227-06 MLS-20130418-12 MLS16-20140411-01 HLS-20120806-01 MLS16-20131216-01 LLS-20111130-04 LLS-20111118-06 LLS-20111130-03 LLS-20111130-02 LLS-20111121-02 MLS-20120703-05 MLS-20130418-17 MLS-20130221-01 MLS-20130715-11 MLS-20130715-10 MLS-20130715-09 LLS-20130109-03 LLS-20111020-01 MLS-20120914-03 MLS16-20130812-04 MLS16-20130708-02 MLS16-20130708-03 MLS16-20130517-01 20110111-01 MLS-20140328-01 LLS-20121114-04 LLS-20120815-01 LLS-20130109-02 LLS-20120420-04 MLS-20130405-11 MLS-20110502-01 20110315-02 LLS-20120104-04 MLS-20120713-01 MLS-20121213-16 LLS-20110725-05 LLS-20110725-04 HLS24-20131227-01 HLS24-20140407-01 MLS-20131104-01 HLS-20131018-02 20110125-02 20110119-02 MLS-20110510-01 MLS-20120206-01 20110114-01 MLS-20120207-02 MLS-20110601-02 MLS-20130405-09 MLS-20120626-01 MLS-20120905-01 MLS-20121010-03 MLS-20120920-08 MLS-20121115-01 MLS-20121231-06 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LLS-20140515-01 LLS-20140519-02 LLS-20140513-02 LLS-20140523-01 HLS-20121026-01 MLS16-20140120-03 MLS16-20140218-04 MLS16-20131209-02 LLS-20120103-13 LLS-20111130-05 MLS16-20140218-03 MLS16-20130819-01 MLS16-20130708-07 MLS-20120130-03 LLS8-20131025-02 LLS8-20121208-01 LLS8-20131016-06 LLS8-20131016-01 LLS8-20131002-01 LLS8-20131025-01 LLS8-20131016-03 LLS8-20131025-03 LLS8-20131016-02 LLS8-20121208-03 LLS8-20121208-04 LLS8-20121208-02 MLS-20110725-03 MLS16-20131028-03 MLS16-20131230-03 20110217-05 LLS-20120517-04 LLS-20120906-02 LLS-20120906-01 20110405-01 HLS-20111208-01 HLS-20120307-03 HLS-20120706-03 20110228-05 20110321-06 20110316-02 20110411-01 20110411-03 20110408-03 20110405-05 20110408-02 HLS-20110602-03 HLS-20110602-01 HLS-20110411-02 HLS-20110405-03 HLS-20120611-01 HLS-20120611-02 HLS-20120620-01 LLS-20120404-02 HLS-20120706-01 HLS-20120706-02 20110222-01 MLS-20110809-05 MLS-20111003-01 MLS-20110825-02 MLS-20110622-02 MLS-20110920-01 MLS-20110908-02 MLS-20110920-05 MLS-20110725-02 MLS-20110818-01 MLS-20110818-02 MLS-20110825-01 MLS-20110909-02 MLS-20110920-02 MLS-20110926-01 HLS-20110701-01 MLS16-20131004-01 MLS16-20131004-03 MLS-20140130-01 MLS-20140417-02 LLS8-20131227-01 20110314-03 20110119-01 MLS-20130715-02 20110314-01 20110301-03 20110228-07 20110228-06 20110228-03 20110228-01 20110217-09 20110217-08 20110217-07 20110217-03 20110112-01 MLS16-20130814-01 MLS16-20131121-05 MLS16-20131121-04 LLS-20120427-02 20110221-02 20110316-03 20110120-02 LLS-20110803-02 20110125-01 20110217-02 20110119-03 20110228-02 20110228-04 20110314-04 20110217-04 MLS-20110722-01 MLS-20110630-02 MLS-20110725-01 20110321-02 20110321-04 MLS-20110509-01 MLS-20110510-04 LLS-20111201-03 HLS-20110919-01 HLS-20111213-01 HLS-20111202-07 HLS-20111202-06 LLS-20110411-05 LLS-20111110-01 LLS-20110411-06 LLS-20110803-03 LLS-20110803-01 LLS-20110728-01 LLS-20110713-07 LLS-20110713-06 LLS-20110711-01 LLS-20110803-05 LLS-20111005-09 LLS-20111013-04 LLS-20111017-01 LLS-20111020-02 LLS-20111130-01 LLS-20111201-02 MLS-20110818-03 LLS-20110513-01 HLS-20110809-04 MLS-20110923-01 HLS-20110809-02 HLS-20110713-02 HLS-20110620-01 HLS-20110822-02 HLS-20110602-02 HLS-20110614-01 HLS-20110830-01 HLS-20110818-04 HLS-20110822-01 HLS-20110701-02 LLS-20110726-01 HLS-20110901-01 MLS-20110922-02 MLS-20110920-04 HLS-20110912-01 MLS-20110908-03 MLS-20110914-02 MLS-20110914-01 MLS-20110909-03 MLS-20110909-01 MLS-20110908-01 MLS-20110829-02 MLS-20131104-02 MLS-20130514-23 HLS16-20111010-05 HLS16-20111010-02 HLS16-20111017-02 HLS16-20111024-12 HLS16-20111017-03 HLS16-20111110-06 HLS16-20111031-05 HLS16-20111114-05 HLS16-20111116-01 HLS16-20111010-01 HLS16-20111117-01 HLS16-20111110-05 HLS16-20111114-04 HLS16-20111116-02 HLS16-20111117-02 HLS16-20111117-03 HLS16-20111118-01 HLS16-20111117-04 HLS16-20111103-01 HLS16-20111024-11 HLS16-20111024-13 HLS16-20111024-14 HLS16-20111024-15 HLS16-20111031-04 HLS16-20111103-02 MLS-20111209-03 LLS-20121112-03 LLS-20121114-02 LLS-20121114-01 HLS-20120104-05 LLS-20120430-01 LLS-20120402-03 LLS-20120305-02 LLS-20120321-01 MLS-20121016-03 MLS-20120914-04 MLS-20120920-01 MLS-20120920-04 LLS8-20131025-05 LLS8-20131025-14 LLS8-20130812-03 LLS8-20131025-06 LLS8-20131025-04 LLS8-20130726-03 LLS8-20131025-08 LLS8-20131025-10 LLS8-20131025-07 LLS8-20131025-12 LLS8-20131025-09 LLS8-20131025-11 LLS8-20131025-13 LLS8-20131104-03 MLS-20130814-01 MLS-20131003-01 MLS-20130916-01 HLS16-20121108-13 HLS16-20121108-14 HLS16-20121108-12 HLS16-20121108-10 HLS16-20121108-05 HLS16-20121108-04 HLS16-20121108-03 HLS16-20121108-02 HLS16-20121129-02 HLS16-20121129-01 HLS16-20121108-11 HLS16-20121108-09 HLS16-20121108-08 HLS16-20121108-06 HLS-20121119-07 MLS-20121114-11 HLS-20121113-01 MLS-20121114-07 MLS-20121107-14 MLS-20121107-15 MLS-20121107-16 MLS-20121114-08 MLS-20121114-09 MLS-20121114-12 MLS-20121107-13 MLS-20121207-02 MLS-20121207-03 MLS-20121207-04 MLS-20121107-01 MLS-20121107-02 MLS-20121107-05 LLS-20121114-06 LLS-20121114-05 LLS-20121112-01 LLS-20121112-02 LLS8-20130214-09 LLS8-20130214-07 LLS8-20130214-08 LLS8-20130214-10 LLS8-20130214-06 LLS8-20130214-11 HLS-20130408-03 HLS-20130408-05 HLS-20130408-01 HLS-20130408-02 HLS-20130408-04 MLS16-20130329-05 HLS32-20130412-01 LLS8-20130524-02 LLS8-20130524-01 MLS16-20140124-04 MLS16-20140303-01 MLS-20130531-02 MLS-20130531-01 LLS8-20130726-06 LLS8-20130812-02 LLS8-20130929-02 MLS16-20130708-04 MLS16-20130717-01 MLS16-20130708-01 MLS16-20130708-05 HLS-20130718-01 HLS24-20131014-02 MLS16-20140331-01 MLS16-20131121-06 HLS-20131024-01 LLS8-20130726-05 LLS8-20130412-01 LLS8-20140603-02 MLS16-20140411-02 LLS8-20140603-01 LLS8-20140610-01 LLS8-20140515-01 MLS-20140117-02 MLS-20140110-01 MLS-20140117-01 MLS16-20131216-02 MLS16-20131018-02 20101101-01 20101208-01
Other Recalls from Karl Storz Endoscopy
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1062-2025 | Class II | KARL STORZ - ENDOSKOPE, REF: 27001K, Ureterosco... | Dec 19, 2024 |
| Z-1052-2025 | Class II | KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Ure... | Dec 19, 2024 |
| Z-1051-2025 | Class II | KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Ure... | Dec 19, 2024 |
| Z-1055-2025 | Class II | KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Re... | Dec 19, 2024 |
| Z-1057-2025 | Class II | KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Re... | Dec 19, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.