Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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.

FDA Recall Z-0928-2012 · Posted 2012-01-29

Recalling FirmVision-Sciences, Inc.
Recall StatusTerminated
Product CodeEOB
Date Initiated2011-12-27
Date Terminated2018-07-06
Product Quantity1618 units

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K100125VISION SCIENCES FLEXIBLE ENT SCOPEVision-Sciences, Inc. · 2010-02-25K050972VISION-SCIENCES ENT-3000 SCOPEVision-Sciences, Inc. · 2005-04-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑