FDA Medical Device Recalls (openFDA)
Vision-Sciences, Inc.: Product is a lithium ion battery sold as both a stand-alone accessory, and as part of endoscopy system sets. Stand alone labeling: Vision Sciences Rechargeable Lithium Ion Batteries, Replacement (2) [REF] 07-3052; [MFG Symbol] Vision-Sciences, Inc., 40 Ramland Road South, Orangeburg, NY 10962 USA. Accessory to endoscopy kits used to charge/recharge lithium ion batteries.
- Recall number
- Z-0929-2012
- Recalling firm
- Vision-Sciences, Inc.
- Product
- Product is a lithium ion battery sold as both a stand-alone accessory, and as part of endoscopy system sets. Stand alone labeling: Vision Sciences Rechargeable Lithium Ion Batteries, Replacement (2) [REF] 07-3052; [MFG Symbol] Vision-Sciences, Inc., 40 Ramland Road South, Orangeburg, NY 10962 USA. Accessory to endoscopy kits used to charge/recharge lithium ion batteries.
- Status
- Terminated
- Initiated
- 2011-12-27
- Posted
- 2012-01-29
- Terminated
- 2018-07-06
- Reason
- 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
- 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
- 3628 batteries
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K050972","K100125"]
- PMA numbers
- not on file
- Product code
- EOB
- Firm FEI
- 2242464
- Firm city
- Orangeburg
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28