Z-0928-2012

Product is a lithium ion battery charger sold as both a stand-alone accessory, and as part of endoscopy...

Name: Z-0928-2012 Product is a lithium ion battery charger sold as both a stand-alone accessory, and as part of endoscopy...
Creator: Vision-Sciences, Inc.
Published: 2011-12-27
License: https://open.fda.gov/license/

Cogentix Medical, Inc. / initiated 2011-12-27 / Terminated / root cause: manufacturing process

FDA source

Vision-Sciences, Inc. began a recall of Product is a lithium ion battery charger sold as both a stand-alone accessory, and as part of endoscopy system sets. --- Stand alone labeling: Vision Sciences... on 2011-12-27. The reason FDA records is "Vision-Sciences is recalling the Vision-Sciences Battery Charger due to reports relating to the potential for over-heating and possible burning of the lithium-ion batteries being charged". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0928-2012
Status: Terminated
Initiated: 2011-12-27
Posted: 2012-01-29
Terminated: 2018-07-06
Recalling firm: Cogentix Medical, Inc.
Product: Product is a lithium ion battery charger sold as both a stand-alone accessory, and as part of endoscopy system sets. --- Stand alone labeling: Vision Sciences Battery Charger, Lithium Ion [REF] 07-3051; [MFG Symbol] Vision-Sciences, Inc., 40 Ramland Road South, Orangeburg, NY 10962 USA. Accessory to endoscopy kits used to charge/recharge lithium ion batteries.
Product code: EOB Nasopharyngoscope (Flexible Or Rigid)
Reason for recall: Vision-Sciences is recalling the Vision-Sciences Battery Charger due to reports relating to the potential for over-heating and possible burning of the lithium-ion batteries being charged.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Vision Sciences sent an "URGENT: PRODUCT RECALL NOTIFICATION" letter dated December 27, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to remove the affected product from inventory. A Tracking/Verification Form was provided for customers to complete and return to the firm. Contact the firm at 800-874-9975 for questions regarding this recall.
Quantity in commerce: 1618 units
Distribution: Worldwide Distribution
Product codes and lots: All units are affected. Products which include this item are VISION SCIENCES CAT. No. ITEM Description; 07-3051 Battery Charger, Lithium-Ion; 07-3051X Battery Charger, Lithium-Ion*; 07-3053 BLS Kit; 07-3053X BLS Kit*; 07-3052 Rechargeable Batteries, Lithium-Ion; 07-3052X Rechargeable Batteries, Lithium-Ion*; 02-2602 ENT-3000 Scope (Standard Set); 02-2602-IN ENT-3000 Scope (Standard Set)*; 02-2602X ENT-3000 Scope (Standard Set)*; 02-4201 ENT-4000 Portable Set; 02-4201X ENT-4000 Portable Set*; * These products were distributed by Medtronic Xomed/ENT.

Product code EOB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)