Panels › Ear, Nose, Throat
Ear, Nose, Throat devices
166 product codes reviewed by the Ear, Nose, Throat panel. 3,804 510(k) clearances and 458 recalls in the FDA data, 68% of those recalls name a 510(k).
50510(k)s in 12 months
39recalls in 12 months
312recalls that name a 510(k)
Codes with the most recalls
| Code | Device | All time | 12 months |
|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | 160 | 5 |
| OGR | Ear, Nose, And Throat Surgical Tray | 77 | 24 |
| ETN | Stimulator, Nerve | 31 | 0 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 29 | 0 |
| NHB | Polymer, Ear, Nose And Throat, Synthetic, Absorbable | 15 | 0 |
| ETD | Tube, Tympanostomy | 14 | 0 |
| KTI | Bronchoscope Accessory | 12 | 0 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 9 | 1 |
| EOX | Esophagoscope (Flexible Or Rigid) | 8 | 0 |
| LXB | Hearing Aid, Bone Conduction | 7 | 0 |
| KCN | Ear Wick | 6 | 0 |
| MMO | Tray, Surgical, Ent | 6 | 1 |
| EWO | Audiometer | 5 | 0 |
| LRC | Instrument, Ent Manual Surgical | 5 | 0 |
| EMX | Balloon, Epistaxis | 4 | 0 |
Active product codes
| Code | Device | Class | 510(k)s, 12 mo | Recalls, 12 mo |
|---|---|---|---|---|
| OGR | Ear, Nose, And Throat Surgical Tray | 1 | 0 | 24 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 2 | 11 | 5 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | 5 | 1 |
| KTI | Bronchoscope Accessory | 2 | 4 | 0 |
| LXB | Hearing Aid, Bone Conduction | 2 | 4 | 0 |
| ETB | Prosthesis, Partial Ossicular Replacement | 2 | 2 | 1 |
| MIB | Elastomer, Silicone Block | 2 | 0 | 3 |
| ETA | Replacement, Ossicular Prosthesis, Total | 2 | 2 | 0 |
| ETN | Stimulator, Nerve | 2 | 2 | 0 |
| EWL | Prosthesis, Laryngeal (Taub) | 2 | 0 | 2 |
| KLW | Masker, Tinnitus | 2 | 2 | 0 |
| NHB | Polymer, Ear, Nose And Throat, Synthetic, Absorbable | 2 | 2 | 0 |
| PDQ | Neurosurgical Nerve Locator | 2 | 2 | 0 |
| SCR | Air-Conduction Hearing Aid Software | 2 | 2 | 0 |
| SHL | Ear, Nose, And Throat Image Analyzer | 2 | 2 | 0 |
| EQN | Laryngoscope, Nasopharyngoscope | 2 | 1 | 0 |
| ETD | Tube, Tympanostomy | 2 | 1 | 0 |
| EWY | Mediastinoscope, Surgical | 2 | 1 | 0 |
| KHJ | Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | 2 | 1 | 0 |
| MAH | Hearing Aid, Bone Conduction, Implanted | 2 | 1 | 0 |
| MIC | Implant, Muscle, Pectoralis | 2 | 0 | 1 |
| MMO | Tray, Surgical, Ent | 1 | 0 | 1 |
| PFO | Active Implantable Bone Conduction Hearing System | 2 | 1 | 0 |
| PNZ | Eustachian Tube Balloon Dilation Device | 2 | 1 | 0 |
| QNW | Reprocessed Bronchoscope | 2 | 0 | 1 |
| QQH | Powered Insertion System For A Cochlear Implant Electrode Array | 2 | 1 | 0 |
| QUH | Self-Fitting Air-Conduction Hearing Aid, Over The Counter | 2 | 1 | 0 |
| QXN | Suction Anti-Choking Device As A Second-Line Treatment | 2 | 1 | 0 |
Latest recalls in this panel
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2026 | Medline Industries, LP Medline surgical convenience kits labeled as:
1) EAR, Medline product number/SKU DYNJ909020B;
2) EAR, Medline product number/SKU DYNJ909020A;
3) CAROTID PACK, Medline product number/SKU DYNJ42922C Open, Classified |
OGR | None listed |
| Oct 1, 2026 | Karl Storz Endoscopy HOPKINS Telescope 30, 4mm REF 10005BA
UDI-DI code: 04048551045121
KARL STORZ HOPKINS and HOPKINS II telescopes are to be used for visualization of the surgical site during diagnostic and therapeutic Open, Classified |
EOB | K945788 |
| Sep 24, 2026 | Medline Industries, LP Medline Convenience Kits:
1) PEDS SINUS PACK, Catalog Number: DYNJ02516G;
2) SINUS PACK-LF, Catalog Number: DYNJ0342705J;
3) NASAL-LF, Catalog Number: DYNJ40094G;
4) ENT PACK, Catalog Number: DYNJ5 Open, Classified |
OGR | None listed |
| Sep 18, 2026 | Medline Industries, LP Medline convenience kits containing Healthmark Instrument Channel Brushes.
SINUS PACK DYNJ48258D and SINUS PACK DYNJ48258F. Open, Classified |
OGR | None listed |
| Sep 3, 2026 | Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:
1) KIT, ENT HARVEST , Catalog Number: PEVMETBJX;
2) KIT, ENT HARVEST , Catalog Number: Open, Classified |
OGR | None listed |
| Aug 26, 2026 | Medline Industries, LP Medline convenience kits labeled as: MAJOR HEAD AND NECK PPS, Medline Kit SKU DYNJ9425991S Open, Classified |
OGR | None listed |
| Aug 21, 2026 | Medline Industries, LP Medline medical convenience kits, labeled as:
1) SINUS PACK-LF, Medline Kit SKU DYNJ0966146F;
2) ENT PACK, Medline Kit SKU DYNJ40154D;
3) ENT PACK, Medline Kit SKU DYNJ40154F;
4) ENT SCOPE PACK, Open, Classified |
OGR | None listed |
| Aug 13, 2026 | Cardinal Health 200, LLC Cardinal Health Presource Kits:
1) ENT TRAY , Catalog Number: 24-0726A;
2) KIT,SINUS , Catalog Number: PE13SPAJA;
3) KIT,SINUS , Catalog Open, Classified |
OGR | None listed |
| Aug 6, 2026 | Freudenberg Medical, LLC Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm
REF: 1610-LF Open, Classified |
EWL | K932120 |
| Aug 6, 2026 | Freudenberg Medical, LLC Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm
REF: 1610-LEF Open, Classified |
EWL | K932120 |
| Jul 24, 2026 | Windstone Medical Packaging, Inc. AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:
1) ENT Pack, Pack Number AMS12206;
2) ENT Pack, Pack Number AMS15517;
3) ENT Facial Pack, Pack Number AMS15863A. Open, Classified |
OGR | None listed |
| Jul 1, 2026 | Windstone Medical Packaging, Inc. A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit Open, Classified |
OGR | None listed |
| Jun 17, 2026 | Medline Industries, LP MEDLINE Medical Procedure Kits labeled as:
ADULT TRACHEOSTOMY TUBE INSERT, ASC T&A, CONWAY T&A SINUS, EAR PACK, etc. (see the recall documents for the full list of products) Open, Classified |
OGR | None listed |
| Jun 12, 2026 | Medline Industries, LP Medline convenience kits:
DISCECTOMY PACK
DYNJ86476B
EAR
DYNJ81460C
DYNJ900004J
DYNJ901779J
DYNJ902900F
EAR PACK
DYNJ81419D
ENT PACK
DYNJ40498B
HEAD & NECK CDS
DYNJ901246J
JEWISH DR SEVERTSON EA Open, Classified |
OGR | None listed |
| Jun 4, 2026 | Grace Medical, Inc. TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L
Model/Catalog Number: 409-375
Product Description: Stapes Prosthesis Open, Classified |
ETB | K060518 |
| May 8, 2026 | Medline Industries, LP Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit Number/SKU DYNJ36478B Open, Classified |
OGR | None listed |
| May 7, 2026 | Medline Industries, LP See RES for full list. Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; 3) HEAD & NECK CDS-LF, Model Numbe Open, Classified |
OGR | None listed |
| Apr 30, 2026 | Medline Industries, LP Medline and Centurion medical procedure kits, containing Medline Neuro Sponges (1229 in total), HEAD & NECK TRAY, SINUS, SMR, etc. Open, Classified |
OGR | None listed |
| Apr 30, 2026 | Medline Industries, LP Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:
1. ZALE STEREOTACTIC CDS, Medline Kit Number/SKU CDS983173G;
2. EPISTAXIS TRAY, Medline Kit Number/SKU DYNDA324 Open, Classified |
MMO | None listed |
| Apr 17, 2026 | Medline Industries, LP Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
MINOR ENT SINUS PACK-LF
DYNJ0101278F
DYNJ0101278G
DYNJ0101278I
SINUS PACK DYNJ56262 Open, Classified |
OGR | None listed |
| Apr 17, 2026 | Medline Industries, LP Medline Kits:
1) ENT PACK, Model Number: DYNJ59030B;
2) ENT, Model Number: DYNJ908586C;
3) LH 3 PORT W/O WASTEBAG, Model Number: VASC1081C Open, Classified |
OGR | None listed |
| Apr 7, 2026 | Medline Industries, LP Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows:
1. HEAD AND NECK CDS-LF, Medline SKU # CDS780138K;
2. Open, Classified |
OGR | None listed |
| Apr 1, 2026 | Medline Industries, LP Medline kits containing Olympus biopsy valves:
1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G
2. FLEXIBLE BRONCHOSCOPY KIT, DYKM1417I DYKM1417J
3. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146A
4. RIGID KIT Open, Classified |
OGR | None listed |
| Mar 3, 2026 | Olympus Corporation of the Americas Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box.
The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent lea Open, Classified |
EOQ | K061313 |
| Mar 3, 2026 | Olympus Corporation of the Americas Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box.
The MAJ-210 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent reflu Open, Classified |
EOQ | K061313 |
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