Panels › General, Plastic Surgery
General, Plastic Surgery devices
466 product codes reviewed by the General, Plastic Surgery panel. 16,352 510(k) clearances and 6,898 recalls in the FDA data, 41% of those recalls name a 510(k).
358510(k)s in 12 months
415recalls in 12 months
2,795recalls that name a 510(k)
Codes with the most recalls
| Code | Device | All time | 12 months |
|---|---|---|---|
| LRO | General Surgery Tray | 1,085 | 104 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 644 | 18 |
| FSY | Light, Surgical, Ceiling Mounted | 454 | 5 |
| KDD | Kit, Surgical Instrument, Disposable | 252 | 16 |
| OJH | Orthopedic Tray | 239 | 35 |
| GDW | Staple, Implantable | 225 | 0 |
| GEX | Powered Laser Surgical Instrument | 201 | 6 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 135 | 7 |
| FYA | Gown, Surgical | 129 | 5 |
| KCY | Tourniquet, Pneumatic | 112 | 70 |
| LRP | Tray, Surgical | 111 | 11 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 107 | 0 |
| GEH | Unit, Cryosurgical, Accessories | 107 | 5 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | 101 | 0 |
| KKX | Drape, Surgical, Antimicrobial | 92 | 3 |
Active product codes
| Code | Device | Class | 510(k)s, 12 mo | Recalls, 12 mo |
|---|---|---|---|---|
| LRO | General Surgery Tray | 2 | 0 | 104 |
| GEX | Powered Laser Surgical Instrument | 2 | 72 | 6 |
| KCY | Tourniquet, Pneumatic | 1 | 0 | 70 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 47 | 18 |
| OHS | Light Based Over The Counter Wrinkle Reduction | 2 | 38 | 0 |
| OJH | Orthopedic Tray | 1 | 0 | 35 |
| KDD | Kit, Surgical Instrument, Disposable | 1 | 0 | 16 |
| OHT | Light Based Over-The-Counter Hair Removal | 2 | 16 | 0 |
| PUI | Drape, Surgical, Exempt | 2 | 0 | 16 |
| FTN | Plastic Surgery And Accessories Kit | 1 | 0 | 15 |
| FYA | Gown, Surgical | 2 | 10 | 5 |
| GEH | Unit, Cryosurgical, Accessories | 2 | 10 | 5 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 2 | 6 | 7 |
| LRP | Tray, Surgical | 1 | 0 | 11 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | 2 | 11 | 0 |
| FTC | Light, Ultraviolet, Dermatological | 2 | 4 | 4 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 2 | 1 | 7 |
| GDC | Table, Operating-Room, Electrical | 1 | 0 | 8 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 2 | 7 | 0 |
| FXX | Mask, Surgical | 2 | 7 | 0 |
| GBX | Catheter, Irrigation | 1 | 0 | 7 |
| NEU | Marker, Radiographic, Implantable | 2 | 4 | 3 |
| NEW | Suture, Surgical, Absorbable, Polydioxanone | 2 | 6 | 0 |
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | 2 | 6 | 0 |
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 2 | 5 | 0 |
| FSY | Light, Surgical, Ceiling Mounted | 2 | 0 | 5 |
| FZP | Clip, Implantable | 2 | 5 | 0 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 2 | 5 | 0 |
| GDW | Staple, Implantable | 2 | 5 | 0 |
| OKI | Emergency Response Safety Kit | 2 | 0 | 5 |
| OLI | Fat Reducing Low Level Laser | 2 | 5 | 0 |
| QPB | System, Suction, Lipoplasty For Removal | 2 | 5 | 0 |
| SCV | Modular Electromechanical Surgical System | 2 | 4 | 1 |
| FSM | Tray, Surgical, Instrument | 1 | 0 | 4 |
| OJU | Skin Prep Tray | 1 | 0 | 4 |
| OWW | Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon | 2 | 1 | 3 |
| PKD | Laceration Tray | 1 | 0 | 4 |
| QAU | Hemostatic Device For Endoscopic Gastrointestinal Use | 2 | 3 | 1 |
| QRL | Multiple Use Blood Lancet For Single Patient Use Only | 2 | 4 | 0 |
| SAH | Magnetic Compression Anastomosis System | 2 | 4 | 0 |
| FYD | Apparatus, Exhaust, Surgical | 2 | 0 | 3 |
| GAP | Suture, Nonabsorbable, Silk | 2 | 0 | 3 |
| GBZ | Catheter, Cholangiography | 1 | 0 | 3 |
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | 2 | 1 | 2 |
| KGO | Surgeon'S Gloves | 1 | 2 | 1 |
| KGZ | Accessories, Catheter | 1 | 0 | 3 |
| KKX | Drape, Surgical, Antimicrobial | 2 | 0 | 3 |
| NEY | System, Ablation, Microwave And Accessories | 2 | 3 | 0 |
| OAB | Low Energy Direct Current Thermal Ablation System | 2 | 3 | 0 |
| ONO | Neurosurgical Laser With Mr Thermography | 2 | 3 | 0 |
| PZX | Left Atrial Appendage Clip, Implantable | 2 | 3 | 0 |
| QPC | Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection | 2 | 3 | 0 |
| FTL | Mesh, Surgical, Polymeric | 2 | 2 | 0 |
| FWP | Prosthesis, Chin, Internal | 2 | 1 | 1 |
| GAQ | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | 2 | 0 | 2 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | 2 | 1 | 1 |
| GFD | Dermatome | 1 | 0 | 2 |
| KGW | Ring (Wound Protector), Drape Retention, Internal | 2 | 2 | 0 |
| LMG | Agent, Absorbable Hemostatic, Non-Collagen Based | 3 | 0 | 2 |
| LRW | Scissors, General, Surgical | 1 | 0 | 2 |
| NVK | Laser, Dental, Soft Tissue | 2 | 2 | 0 |
| OHO | First Aid Kit Without Drug | 1 | 0 | 2 |
| OJJ | Burn Kit Without Drug | 1 | 0 | 2 |
| OVN | Suture Kit | 2 | 0 | 2 |
| OWT | Mesh, Surgical, Absorbable, Abdominal Hernia | 2 | 2 | 0 |
| PEM | Dental Barriers And Sleeves | 2 | 2 | 0 |
| PZP | Fluid Jet Removal System | 2 | 2 | 0 |
| QAI | Powered Microneedle Device | 2 | 2 | 0 |
| QJF | Autofluorescence Imaging Adjunct Tool For Wounds | 2 | 1 | 1 |
| QRK | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | 2 | 2 | 0 |
| QSO | Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs | 2 | 2 | 0 |
| QUW | Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament | 2 | 2 | 0 |
| SDD | Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field | 2 | 2 | 0 |
| BWN | Table And Attachments, Operating-Room | 1 | 0 | 1 |
| ESW | Prosthesis, Esophageal | 2 | 1 | 0 |
| FQO | Table, Operating-Room, Ac-Powered | 1 | 0 | 1 |
| FSH | Tray, Surgical, Needle | 1 | 0 | 1 |
| FTA | Light, Surgical, Accessories | 2 | 0 | 1 |
| FTM | Mesh, Surgical | 2 | 1 | 0 |
| GAD | Retractor | 1 | 0 | 1 |
| GBW | Catheter, Peritoneal | 1 | 0 | 1 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 1 | 0 | 1 |
| KQM | Camera, Surgical And Accessories | 1 | 0 | 1 |
| LMF | Agent, Absorbable Hemostatic, Collagen Based | 3 | 0 | 1 |
| LZK | Implant, Malar | 2 | 0 | 1 |
| MCZ | Suture Removal Kit | 1 | 0 | 1 |
| MDM | Instrument, Manual, Surgical, General Use | 1 | 0 | 1 |
| NAC | Dressing, Wound, Hydrophilic | 1 | 0 | 1 |
| NAD | Dressing, Wound, Occlusive | 1 | 1 | 0 |
| NUV | Massager, Vacuum, Light Induced Heating | 2 | 1 | 0 |
| NWA | Prosthesis, Tracheal, Preformed/Molded | 2 | 1 | 0 |
| OEA | Non-Surgical Gown | 1 | 0 | 1 |
| OHV | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption | 2 | 1 | 0 |
| OKO | Negative Pressure Wound Therapy Non-Powered Suction Apparatus | 2 | 1 | 0 |
| OLP | Over-The-Counter Powered Light Based Laser For Acne | 2 | 1 | 0 |
| ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 2 | 1 | 0 |
| OTN | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | 2 | 1 | 0 |
| OWX | Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon | 2 | 1 | 0 |
| OXC | Mesh, Surgical, Absorbable, Staple Line Reinforcement | 2 | 1 | 0 |
| PAY | Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction | 2 | 1 | 0 |
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Latest recalls in this panel
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 5, 2026 | AVID Medical, Inc. Halyard ARTHROSCOPY PACK. Model/Catalog Number: SAMM014-21. Open, Classified |
LRO | None listed |
| Nov 3, 2026 | Baxter Healthcare Corporation TruSystem 7500 Hybrid Plus (FC), Fixed-Installation Operating Table Column, Model/Catalog Number: 1854087 Open, Classified |
GDC | None listed |
| Nov 3, 2026 | Baxter Healthcare Corporation Operating Table TruSystem 7000 U (dV), Model/Catalog Number: 1723633 Open, Classified |
GDC | None listed |
| Nov 3, 2026 | Baxter Healthcare Corporation Operating Table TruSystem 7000 U, Surgical table, universal, Model/Catalog Number: 1604788 Open, Classified |
GDC | None listed |
| Nov 3, 2026 | Baxter Healthcare Corporation Operating table column TS7500 MOBIUS, Hybrid operating table column, Model/Catalog Number: 1704695 Open, Classified |
GDC | None listed |
| Nov 3, 2026 | Baxter Healthcare Corporation TruSystem 7500 surgical table, Model/Catalog Number: 4091000 Open, Classified |
GDC | None listed |
| Nov 3, 2026 | Baxter Healthcare Corporation Mobile column TruSystem 7500 U, Product Code 1730720 Open, Classified |
GDC | None listed |
| Nov 3, 2026 | Henry Schein Inc. Generic Name: Perma Sharp Sutures;
Generic Name: Polypropylene Nonabsorbable Surgical Suture;
Model/Catalog Number: PSN8695P (HSI Item No. 600-9795);
Product Description: Sterile, synthetic, nonabsorb Open, Classified |
GAW | None listed |
| Nov 3, 2026 | Henry Schein Inc. Generic Name: Perma Sharp Sutures;
Generic Name: PGA Absorbable Surgical Suture;
Model/Catalog Number: PSN387V (HSI Item No. 600-9683);
Product Description: Sterile, synthetic, absorbable, braided 6-0 Open, Classified |
GAM | None listed |
| Nov 3, 2026 | Henry Schein Inc. Generic Name: Perma Sharp Sutures;
Generic Name: PGA Absorbable Surgical Suture;
Model/Catalog Number: PSN392V (HSI Item No. 600-9613);
Product Description: Sterile, synthetic, absorbable, braided 4-0 Open, Classified |
GAM | None listed |
| Nov 3, 2026 | Henry Schein Inc. Generic Name: Perma Sharp Sutures;
Generic Name: PGA Absorbable Surgical Suture;
Model/Catalog Number: PSN388V (HSI Item No. 600-8803);
Product Description: Sterile, synthetic, absorbable, braided 5-0 Open, Classified |
GAM | None listed |
| Nov 3, 2026 | Henry Schein Inc. Generic Name: Perma Sharp Sutures;
Generic Name: Polypropylene Nonabsorbable Surgical Suture;
Model/Catalog Number: PSN8384P (HSI Item No. 600-7664);
Product Description: Sterile, synthetic, nonabsorb Open, Classified |
GAW | None listed |
| Nov 3, 2026 | Henry Schein Inc. Generic Name: Perma Sharp Sutures;
Generic Name: Polypropylene Nonabsorbable Surgical Suture;
Model/Catalog Number: PSN8660P (HSI Item No. 600-7193);
Product Description: Sterile, synthetic, nonabsorb Open, Classified |
GAW | None listed |
| Nov 3, 2026 | Henry Schein Inc. Generic Name: Perma Sharp Sutures;
Generic Name: PGA Absorbable Surgical Suture;
Model/Catalog Number: PSN421V (HSI Item No. 600-6870);
Product Description: Sterile, synthetic, absorbable, braided 5-0 Open, Classified |
GAM | None listed |
| Nov 3, 2026 | Henry Schein Inc. Generic Name: Perma Sharp Sutures;
Generic Name: Silk Nonabsorbable Surgical Suture;
Model/Catalog Number: PSN683S (HSI Item No. 600-6411);
Product Description: Sterile, natural, nonabsorbable, braide Open, Classified |
GAP | None listed |
| Nov 3, 2026 | Henry Schein Inc. Generic Name: Perma Sharp Sutures;
Generic Name: Polypropylene Nonabsorbable Surgical Suture;
Model/Catalog Number: PSN8698P (HSI Item No. 600-5659);
Product Description: Sterile, synthetic, nonabsorb Open, Classified |
GAW | None listed |
| Nov 3, 2026 | Henry Schein Inc. Generic Name: Perma Sharp Sutures;
Generic Name: Silk Nonabsorbable Surgical Suture;
Model/Catalog Number: PSN632S (HSI Item No. 600-3506);
Product Description: Sterile, natural, nonabsorbable, braide Open, Classified |
GAP | None listed |
| Nov 3, 2026 | Henry Schein Inc. Generic Name: Perma Sharp Sutures;
Generic Name: Silk Nonabsorbable Surgical Suture;
Model/Catalog Number: PSN7772S (HSI Item No. 600-3090);
Product Description: Sterile, natural, nonabsorbable, braid Open, Classified |
GAP | None listed |
| Nov 3, 2026 | Henry Schein Inc. Generic Name: Perma Sharp Sutures;
Generic Name: PGA Absorbable Surgical Suture;
Model/Catalog Number: PSN397V (Henry Schein Item No. 600-0331);
Product Description: Sterile, synthetic, absorbable, br Open, Classified |
GAM | None listed |
| Nov 3, 2026 | Henry Schein Inc. Generic Name: Perma Sharp Sutures;
Generic Name: Polypropylene Suture;
Model/Catalog Number: PSN8696P (Henry Schein Item No. 600-0115);
Product Description: Sterile, non-absorbable 7-0 blue polypropyl Open, Classified |
GAW | None listed |
| Nov 3, 2026 | Baxter Healthcare Corporation TruSystem 7000 U Operating Table (dV), Product Code 1723633 Open, Classified |
GDC | None listed |
| Nov 3, 2026 | AVID Medical, Inc. Halyard MINOR PACK. Model/Catalog Number: VASF105-08. Open, Classified |
LRO | None listed |
| Nov 2, 2026 | Cardinal Health 200, LLC Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: KIT EMERGENCY BASKET GENERAL, CATALOG # RES307732A Open, Classified |
OKI | None listed |
| Nov 2, 2026 | Cardinal Health 200, LLC Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as:
1) KIT, ANTEPARTUM IV , CATALOG # MA1DH7533C;
2) KIT, Open, Classified |
LRP | None listed |
| Nov 2, 2026 | Cardinal Health 200, LLC Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as:
1) KIT,C SECTION ADMIT,, CATALOG # MATJV8300D;
2) KIT,C SECTION Open, Classified |
LRO | None listed |
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