Vision-Sciences, Inc.

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.

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution

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.

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.

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution

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.