All lots and codes manufactured between May 2010 and July 2011.

Ear, Nose, and Throat Devices

1

No

US Nationwide Distribution.

Water Pik Sinusense battery operated device including a blue semi-transparent water reservoir, a white hand held button initiated injector device, and a soft seal nozzle affixed to the white injector. The product is sold individually in white, blue red and orange cartons with a photo of the device as well as a stream of water flowing through it. The contents of the container include the device as well as a package insert with utilization instructions. || Product Usage: Sinus washing device to keep sinus passages clear of congestion.

Model Numbers 1016, 1016EU, R1016ES; GXXXX64 All units Made in Costa Rica are affected Lot Numbers:    12089A 12131A   5575A 5586X 5633U 5664E 5685G 5712T  12090B 12138A 5578K 5603R 5636Y 5666R 5685H  5714Z  12100A 12157B 5578L 5606U 5638P 5668N 5685J  12101B 12173A 5580Y 5614N 5638Q 5669G 5689Y  12102A 5573Q 5580Z 5615N 5648T 5669H 5691T  12108B 5574A 5581A 5621U 5648U 5671D 5692H  12109B 5574B 5581L 5623H 5653Z 5673V 5696Q  12114B 5574X 5583E 5631C 5658D 5683V 5700J  12117B 5574Y 5584C 5632V 5660C 5683W 5703N  12130B 5574Z 5584D 5633T 5664D 5683X 5708R

Ear, Nose, and Throat Devices

1

No

Worldwide distribution: USA (nationwide) including states of: AR, CA, FL,GA, IL, LA, MA, MI, MO, NC, NH, NY, OH, OK, PA, RI, SE,TX, and WA; and countries of: AUSTRALIA, BARCELONA, GERMANY, NEW ZEALAND, NETHERLANDS, SWITZERLAND, and UNITED KINGDOM.

Vital Signs Disposable General Purpose 9 French Temperature Probe || For monitoring of core temperature

Serial Number G11307654403

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution: US (nationwide) including Puerto Rico and states of: AL, AR, AZ, CA, CO, CT, DC, DE, GA, FL, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, VE, VT, WA, WI, WY, and WV. Internationally to: AT, AU, BR, BS, CA, CH, CL, CO, CZ, CR, DE, DK, DO, EG, ES, FI, FR, GB, GR, HK, HU, ID, IL, IN, IS, JP, KH, KR, LB, LT, MX, MY, NL, NO, NZ, PA, PE, PH, PL, PT, SA, SG, SY, TH, TR, TW, and ZA.

***REF XMAX***XMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. || Intended for cutting and shaping bone.

Serial Number MM900

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution: US (nationwide) including Puerto Rico and states of: AL, AR, AZ, CA, CO, CT, DC, DE, GA, FL, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, VE, VT, WA, WI, WY, and WV. Internationally to: AT, AU, BR, BS, CA, CH, CL, CO, CZ, CR, DE, DK, DO, EG, ES, FI, FR, GB, GR, HK, HU, ID, IL, IN, IS, JP, KH, KR, LB, LT, MX, MY, NL, NO, NZ, PA, PE, PH, PL, PT, SA, SG, SY, TH, TR, TW, and ZA.

***REF MICROMAX***microMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. || Intended for cutting and shaping bone.

Lot Number: LFG-111813-1; Expiry date: June 2014; LFG020614-01, Expiry date: September 2014.

Ear, Nose, and Throat Devices

2

No

Distributed in the states of CA, VT, NC, DO, TX, FL, PA, OR, AZ, IL, ID, and VA.

PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter. Sterile. Used for the excision of polyps in the nasal passageways and in sinuses for which access has been previously established.

Outer Package Lot COH523440, COH485876, and COH484221 with/Device Lot No. 131008

Ear, Nose, and Throat Devices

2

No

Nationwide Distribution.

Cochlear Baha Soft tissue gauge 6mm. || Reusable instrument used to ensure the soft tissue thickness is equal to or less than 6 mm. For use with Baha Attract hearing system.

Model #'s FB-10V, FB015BS, FB-15P, FB-15RBS, FB-15V, FB-18BS, FB-18P, FB-18RBS, FB-18V, FB-19TV, FB-8V, EB--1530T3, EB-1170K, EB01570K, EB-1575K, EB-1970K, EB-1970-TK and EB-1975K

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam

Bronchoscope || Intended to provide optical visualization of and therapeutic access to the Airway and Bronchial Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Nasal Passage, Trachea and Bronchial Tree. The instrument is introduced via the mouth or the nose, as decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

Model #VNL-1570STK

Ear, Nose, and Throat Devices

1

No

Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam

Laryngo Stroboscope || Product Usage Intended to provide optical visualization of, therapeutic access to, the Upper Airway and Vocal Folds. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Larynx, Pharynx and Vocal Cords. The instrument is introduced via the mouth or the nose, as decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

Model #'s FNL-10RAP, FNL-13RAP, FNL-15RP3 and VNL-1530T

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam

Naso-Pharyngo-Laryngoscope || Intended to provide optical visualization of, therapeutic access to, the Upper Airway. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Ear, Nasal Passage and Trachea. The instrument is introduced via the mouth or the nose, as decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric patient populations

Model #EB-1970UK

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam

Ultrasound Bronchoscope || Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Pulmonary Tract including but not restricted to organs, tissues and subsystems: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations

Catalog No. (UDI-DI): MBUR5060FRCV (00821925036529), MBUR6060FRCV (00821925036536), and MBUR7060FRCV (00821925036543) ALL LOTS MANUFACTURED BEFORE AUGUST 3, 2017

Ear, Nose, and Throat Devices

1

No

NM, MI, and TX EU, Australia, Japan, and Hong Kong

Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system

Catalog # 4173, Lot number 038594A1.

Ear, Nose, and Throat Devices

1

No

Nationwide domestic distribution. Foreign distribution to Canada and Saudia Arabia. No government and military consignees.

GENT-L-KARE Sterile 3OZ. EAR/ULCER BULB SYRINGE SINGLE USE

Size 12x40, Part #90129-20, Lot #AC0406; Size 14x40, Part #90129-21, Lot #AC0409; Size 16x40, Part #90129-22, Lot #AA0411; Size 16x60, Part #90129-23, Lot #A0413; Size 12x20, Part #90129-24, Lot #AA0404; Size 14x40, Part #90129-25, Lot 3AA0409; Size 14x40, Part #90129-26, Lot #AC0409; Size 16x60, Part #90129-27, Lot #AA0413

Ear, Nose, and Throat Devices

2

No

FL, SC, TX

Alveolus Tracheobronchial Stent Technology System (TB-STS), Manufactured for: Alveolus Inc., 401 North Tryon Street, Charlotte, North Carolina USA 28202

Lot # 233270

Ear, Nose, and Throat Devices

1

No

Product was distributed to one distributor in Argentina.

Labeled in part:"***BIOMET MICROFIXATION***BIOMET MICROFIXATION***1520 TRADEPORT DRIVE***JACKSONVILLE, FL 33218 USA***www.biometfixation.com***2.0 MM X 7.0 MM TITANIUM***#01-6577***LOT XXXXXX***QTY 00001***X-DRIVE FOSSA SCREW 5/PKG***2.0 MM X 7.0 MM***". || Bone screws intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system. These screws are to be used with our TMJ (Temporal Mandibular Joint) implants.

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.

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.

Article 10448446, serial numbers 181011001, 181011009, 181011005, 181011003, 250811007, 28101108, 151111011, 211111007, 251111006 and 251111004. The corrected units will have controller software version MDC V3.6 pack G

Ear, Nose, and Throat Devices

1

No

Worldwide distribution: USA (nationwide) including states of: California, Colorado, Illinois, New York, Oregon, South Carolina; and countries of: Australia, Japan, Korea, Pakistan, Romania, South Africa, Switzerland and Turkey.

Leica M822 Surgical Microscope Device Controller Software (MDC version 3.6, pack F, affecting the control unit component, Article #10448446, in combination with a Leica M822 Optics Carrier-XY-Focus-Tilt-Unit, article #10448587; Leica Microsystems (Schweiz) AG, Max Schmidheiny-Strasse 201, CH-9425, Heerbrugg, Switzerland || The intended use of the microscope is for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.

Product code BC1840A, Size 18 x 40: Lot 110307E, Exp 3/2013; Lot 110429E, Exp 4/2013; Lot 110502B, Exp 5/2013; Lot 110506B, Exp 5/2013; Lot 110606B, Exp 6/2013; Lot 110614B, Exp 6/2013.

Ear, Nose, and Throat Devices

2

No

Nationwide Distribution (USA) only sixe 18 x 40 Worldwide distribution other sizes.Distirbution to France, Canada, Saudi Arabia

Inspira AIR Balloon Dilation System, || size 18 x 40; || Manufactured by Acclarent, Inc. || 1525-G O'Brien Drive, Menlo Park, CA 94025 || Product Usage: Dilation of airway tree.

Model number P02011 - Right, Lot M1110 and M1112 and P020012 - Left, lot M1109, M1111 and M1113.

Ear, Nose, and Throat Devices

2

No

Class III Recall - Nationwide Distribution, including the states of CA, AZ, PA, MI, UT, NC, NY, WI, TX, FL and DC.

SoundBite Hearing System; Microphone Tube Size 0. For use in patients with moderately severe, severe or profound sensorineural hearing loss in one ear and normal hearing in the other or patients with conductive hearing loss where the pure tone average bond-conduction hearing threshold is better than or equal to 25 dB HL. Sonitus Medical, San Mateo, CA.

Model number P02013 - Right, lot M1098, M1106 and P020014 - Left, lot M109, M1102 and M1107.

Ear, Nose, and Throat Devices

2

No

Class III Recall - Nationwide Distribution, including the states of CA, AZ, PA, MI, UT, NC, NY, WI, TX, FL and DC.

SoundBite Hearing System; Microphone Tube Size 1. For use in patients with moderately severe, severe or profound sensorineural hearing loss in one ear and normal hearing in the other or patients with conductive hearing loss where the pure tone average bond-conduction hearing threshold is better than or equal to 25 dB HL. Sonitus Medical, San Mateo, CA.

Model number P02015 - Right, lot M1099 and P020016 - Left, lot M1096, M1103.

Ear, Nose, and Throat Devices

2

No

Class III Recall - Nationwide Distribution, including the states of CA, AZ, PA, MI, UT, NC, NY, WI, TX, FL and DC.

SoundBite Hearing System; Microphone Tube Size 2. For use in patients with moderately severe, severe or profound sensorineural hearing loss in one ear and normal hearing in the other or patients with conductive hearing loss where the pure tone average bond-conduction hearing threshold is better than or equal to 25 dB HL. Sonitus Medical, San Mateo, CA.

Model number P02017 - Right,lot M1100 and P020018 - Left, lot M1104, M1097.

Ear, Nose, and Throat Devices

2

No

Class III Recall - Nationwide Distribution, including the states of CA, AZ, PA, MI, UT, NC, NY, WI, TX, FL and DC.

SoundBite Hearing System; Microphone Tube Size 3. For use in patients with moderately severe, severe or profound sensorineural hearing loss in one ear and normal hearing in the other or patients with conductive hearing loss where the pure tone average bond-conduction hearing threshold is better than or equal to 25 dB HL. Sonitus Medical, San Mateo, CA.

Model number P02019 - Right, lot M1102 and P020020 - Left, lot M1105.

Ear, Nose, and Throat Devices

2

No

Class III Recall - Nationwide Distribution, including the states of CA, AZ, PA, MI, UT, NC, NY, WI, TX, FL and DC.

SoundBite Hearing System; Microphone Tube Size 4. For use in patients with moderately severe, severe or profound sensorineural hearing loss in one ear and normal hearing in the other or patients with conductive hearing loss where the pure tone average bond-conduction hearing threshold is better than or equal to 25 dB HL. Sonitus Medical, San Mateo, CA.

Lot Numbers 0310, 0510, 2710, 3210, 4010 & 4510

Ear, Nose, and Throat Devices

2

No

US Distribution to the state of California.

BOMImed Reusable Integrated Fiber Optic Laryngoscope Blades, MacIntosh and Miller styles - all sizes. Instrument is used to aid with intubation.

Lot#1008419

Ear, Nose, and Throat Devices

2

No

Worldwide distribution: USA (nationwide) including state of: Ohio and country of United Kingdom

BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO || The Blom-Singer Indwelling (TEP(tracheoesophageal Puncture) Occluder is a non-valved silicone prosthesis designed for placement in and maintenance of the TE (tracheoesophageal) puncture following total laryngectomy. The Blom-Singer Indwelling TEP (tracheoesophageal Puncture) Occluder is indicated for placement in and maintenance of the TE puncture following total laryngectomy when placement, or replacement, of an indwelling prosthesis is performed by a qualified, trained medical professional.