AUDIOLOGISTS CHOICE EARWAX REMOVAL SYSTEM (carbamide peroxide) liquid [Oaktree Products Inc.]
Updated Date: Fri, 15 Dec 2023 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - December 15, 2023 Category: Drugs & Pharmacology Source Type: alerts
AUDIOLOGIST ANTI-ITCH (hydrocortisone) cream [OAKTREE PRODUCTS, INC.]
Updated Date: Wed, 13 Dec 2023 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - December 13, 2023 Category: Drugs & Pharmacology Source Type: alerts
MEDLINE INDUSTRIES, LP - Northfield - Custom Sterile and NonSterile Procedural Kits containing Turkuaz Ultrasound Gel - Class 2 Recall
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CAROTID, Model Number: DYNJ54287A; b. CAROTID PACK, Model Number: DYNJ66190; c. CAROTID SUPPLY, Model Number: DYNJ905622C; d. CAROTID-LF, Model Number: DYNJ901745J; e. CENTRAL LINE INSERTION, Model Number: DYNJ63347A; f. CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; g. DBD-CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; h. DBD-IR THYROID PACK THLUF642-LF, Model Number: DYNJ47716B; i. ENT FREE FLAP, Model Number: SYNJ910018A; j. ENT FREE FLAP PACK, Model Number: DYNJ67954...
Source: Medical Device Recalls - August 4, 2023 Category: Medical Devices Source Type: alerts
MEDLINE INDUSTRIES, LP - Northfield - Medline Probe Cover Kits - Class 2 Recall
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CHP COCHLEAR SUPPLEMENT CDS, Model Number CDS983069I; b) HEAD AND NECK PACK, Model Number DYNJ30245; c) IR THYROID PACK (THLUF)642-LF, Model Number DYNJ47716B; d) CENTRAL LINE INSERTION, Model Number DYNJ63347A; e) TAVR FAIRFAX, Model Number DYNJ63634A; f) PARATHYROID PACK, Model Number DYNJ81389A; g) THYRIOD PACK, Model Number DYNJ83960; h) WMC COCHLEAR IMPLANT ADD ON, Model Number DYNJ907206D (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 21, 2023 Category: Medical Devices Source Type: alerts
AUDIOLOGISTS CHOICE EARWAX REMOVAL AID DROPS (carbamide peroxide) solution/ drops [Oaktree Products Inc]
Updated Date: Wed, 24 Feb 2021 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - February 24, 2021 Category: Drugs & Pharmacology Source Type: alerts
Advanced Bionics, LLC - HiResolution Bionic Ear System - Class 2 Recall
AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 16, 2020 Category: Medical Devices Source Type: alerts
Advanced Bionics, LLC - HiResolution Bionic Ear System - Class 2 Recall
AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 16, 2020 Category: Medical Devices Source Type: alerts
Advanced Bionics, LLC - Soundwave Professional Suite Software 3.2 - Class 3 Recall
SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, UDI: (01)07630016853227, Logical SoundWave Professional Suite 3.2, CE 0123 - Product Usage: Soundwave 3.2 is used by healthcare professionals to program Advanced Bionics sound processors for use with Advanced Bionics cochlear implants, a device is intended to restore a level of auditory sensation to children with profound sensorineural deafness via electrical stimulation of the auditory nerve. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 5, 2020 Category: Medical Devices Source Type: alerts
Advanced Bionics, LLC - HiResolution Bionic Ear System - Class 3 Recall
HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 19, 2020 Category: Medical Devices Source Type: alerts
Cochlear Americas Inc. - Baha 5 Tamper Proof Battery Door (3 pcs) - Class 2 Recall
Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.) (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 25, 2020 Category: Medical Devices Source Type: alerts
GN Otometrics - Gold Cup Electrode and Snap Electrode Leads - Class 2 Recall
Gold Cup Leadwire and Snap Leadwire with the following component descriptions: 1. 24" Snap Leadwire, Blue; 2. 40" Snap Leadwire, Blue; 3. 24" Snap Leadwire, Red; 4. 40" Snap Leadwire, Red; 5. 24" Snap Leadwire, Green; 6. 40" Snap Leadwire, Green; 7. 24" Snap Leadwire, Brown; 8. 40" Snap Leadwire, Brown; 9. 24" Snap Leadwire, Orange; 10. 40" Snap Leadwire, Orange; 11. 24" Snap Leadwire, White; 12. 40" Snap Leadwire, White; 13. 24" Snap Leadwire, Black; 14. 40" Snap Leadwire, Black; 15. 24" Snap Leadwire, Yellow; 16. 40...
Source: Medical Device Recalls - September 24, 2019 Category: Medical Devices Source Type: alerts
MED-EL Elektromedizinische Gereate, Gmbh - Cochlear Implant - Class 2 Recall
MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types: a. SONATAti100 FLEXsoft; b. SONATAti100 H Standard; c. SONATAti100 Standard Product Usage: The SONATATIi100 Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 3, 2019 Category: Medical Devices Source Type: alerts
MED-EL Elektromedizinische Gereate, Gmbh - Cochlear Implant - Class 2 Recall
MED EL Cochlear Implant System, PULSARci100 Standard - Product Usage: The PULSARci100 Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 3, 2019 Category: Medical Devices Source Type: alerts
MED-EL Elektromedizinische Gereate, Gmbh - Cochlear Implant - Class 2 Recall
MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the following implant types: a. Mil000 CONCERTO PIN +FLEX28; b. Mi1000 CONCERTO +FLEX28; c. Mi1000 CONCERTO PIN +FLEXsoft; d. Mil000 CONCERTO +Standard; e. Mil000 CONCERTO +Medium; f. Mi1000 CONCERTO PIN +Standard; g. M11000 CONCERTO +Compressed Product Usage: The Mi1000 CONCERTO Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathw...
Source: Medical Device Recalls - August 3, 2019 Category: Medical Devices Source Type: alerts
AUDIOLOGIST ANTI-ITCH (Hydrocortisone) Cream [OAKTREE PRODUCTS, INC.]
Updated Date: Apr 1, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 1, 2019 Category: Drugs & Pharmacology Source Type: alerts
