Recalls within a year of 510(k) clearance
The latest device recalls that name a 510(k) cleared less than 12 months before the recall, with the time between the two.
48,562recall to 510(k) links with both dates
2,756 daysmedian time from clearance to recall
5.5%recalled within a year
| Recall | Firm | Code | 510(k) | Days after clearance |
|---|---|---|---|---|
| Oct 22, 2026 | Medtronic MiniMed, Inc. | NDC Calculator, Drug Dose | K253512 Jan 8, 2026 | 287 |
| Oct 16, 2026 | Think Surgical, Inc. | OLO Orthopedic Stereotaxic Instrument | K261024 Jul 24, 2026 | 84 |
| Oct 15, 2026 | Merit Medical Systems, Inc. | NEU Marker, Radiographic, Implantable | K252892 Dec 19, 2025 | 300 |
| Oct 7, 2026 | Mindray DS USA, Inc. | MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | K260098 May 20, 2026 | 140 |
| Oct 5, 2026 | Medtronic MiniMed, Inc. | QFG Alternate Controller Enabled Insulin Infusion Pump | K253743 Mar 12, 2026 | 207 |
| Sep 29, 2026 | Penumbra Inc. | NRY Catheter, Thrombus Retriever | K250690 Jun 10, 2026 | 111 |
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. | JAK System, X-Ray, Tomography, Computed | K253173 Jan 20, 2026 | 248 |
| Sep 25, 2026 | Volcano Corp | IYO System, Imaging, Pulsed Echo, Ultrasonic | K253714 Feb 24, 2026 | 213 |
| Sep 25, 2026 | Bard Peripheral Vascular Inc | KNW Instrument, Biopsy | K252681 Dec 12, 2025 | 287 |
| Sep 18, 2026 | Philips Ultrasound, LLC | IYN System, Imaging, Pulsed Doppler, Ultrasonic | K260123 May 27, 2026 | 114 |
| Sep 18, 2026 | Philips Ultrasound, LLC | IYN System, Imaging, Pulsed Doppler, Ultrasonic | K260680 May 27, 2026 | 114 |
| Sep 16, 2026 | Howmedica Osteonics Corp. | NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | K252898 Dec 15, 2025 | 275 |
| Sep 16, 2026 | Howmedica Osteonics Corp. | KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | K261624 Jul 10, 2026 | 68 |
| Sep 16, 2026 | Howmedica Osteonics Corp. | KWL Prosthesis, Hip, Hemi-, Femoral, Metal | K261624 Jul 10, 2026 | 68 |
| Sep 16, 2026 | Wilson-Cook Medical Inc. | QAU Hemostatic Device For Endoscopic Gastrointestinal Use | K253302 Jun 2, 2026 | 106 |
| Aug 5, 2026 | Hardy Diagnostics | JTN Susceptibility Test Discs, Antimicrobial | K253105 Nov 20, 2025 | 258 |
| Aug 3, 2026 | Oxos Medical Inc | OWB Interventional Fluoroscopic X-Ray System | K252068 Dec 22, 2025 | 224 |
| Jul 27, 2026 | Medtronic Perfusion Systems | DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | K260195 Apr 23, 2026 | 95 |
| Jul 27, 2026 | Medtronic Perfusion Systems | DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | K260195 Apr 23, 2026 | 95 |
| Jul 23, 2026 | Medtronic MiniMed, Inc. | NDC Calculator, Drug Dose | K253512 Jan 8, 2026 | 196 |
| Jul 23, 2026 | Alphatec Spine, Inc. | GWF Stimulator, Electrical, Evoked Response | K252842 Jan 11, 2026 | 193 |
| Jul 22, 2026 | Boston Scientific Corporation | LLZ System, Image Processing, Radiological | K252547 Oct 28, 2025 | 267 |
| Jul 22, 2026 | Boston Scientific Corporation | LLZ System, Image Processing, Radiological | K260479 Mar 13, 2026 | 131 |
| Jul 21, 2026 | PIE Medical Imaging B.V. | QIH Automated Radiological Image Processing Software | K250330 Nov 3, 2025 | 260 |
| Jul 9, 2026 | CMR SURGICAL LIMITED | SCV Modular Electromechanical Surgical System | K252111 Dec 16, 2025 | 205 |
| Jul 9, 2026 | Think Surgical, Inc. | OLO Orthopedic Stereotaxic Instrument | K260010 Mar 3, 2026 | 128 |
| Jun 29, 2026 | Medacta Usa Inc | PHX Shoulder Prosthesis, Reverse Configuration | K250644 Feb 3, 2026 | 146 |
| Jun 24, 2026 | SURGIFY MEDICAL OY | HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) | K253627 Mar 26, 2026 | 90 |
| Jun 24, 2026 | SURGIFY MEDICAL OY | HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) | K253627 Mar 26, 2026 | 90 |
| Jun 24, 2026 | SURGIFY MEDICAL OY | HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) | K253627 Mar 26, 2026 | 90 |
| Jun 24, 2026 | SURGIFY MEDICAL OY | HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) | K253627 Mar 26, 2026 | 90 |
| Jun 24, 2026 | SURGIFY MEDICAL OY | HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) | K253627 Mar 26, 2026 | 90 |
| Jun 24, 2026 | SURGIFY MEDICAL OY | HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) | K253627 Mar 26, 2026 | 90 |
| Jun 24, 2026 | SURGIFY MEDICAL OY | HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) | K253627 Mar 26, 2026 | 90 |
| Jun 24, 2026 | SURGIFY MEDICAL OY | HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) | K253627 Mar 26, 2026 | 90 |
| Jun 24, 2026 | SURGIFY MEDICAL OY | HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) | K253627 Mar 26, 2026 | 90 |
| Jun 24, 2026 | SURGIFY MEDICAL OY | HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) | K253627 Mar 26, 2026 | 90 |
| Jun 24, 2026 | SURGIFY MEDICAL OY | HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) | K253627 Mar 26, 2026 | 90 |
| Jun 23, 2026 | Acumed LLC | HRS Plate, Fixation, Bone | K251132 Jul 14, 2025 | 344 |
| Jun 18, 2026 | Beta Bionics, Inc. | QFG Alternate Controller Enabled Insulin Infusion Pump | K252770 Sep 29, 2025 | 262 |
| Jun 11, 2026 | Boston Scientific Corporation | ODC Endoscope Channel Accessory | K252910 Oct 9, 2025 | 245 |
| Jun 9, 2026 | The Binding Site Group, Ltd. | OTA Mass Spectrometer For Clinical Multiplex Test Systems | K250159 Oct 17, 2025 | 235 |
| Jun 5, 2026 | GE Medical Systems, LLC | OWB Interventional Fluoroscopic X-Ray System | K251199 Dec 9, 2025 | 178 |
| May 15, 2026 | TANGENT ENDOSCOPY, LLC | FBN Choledochoscope And Accessories, Flexible/Rigid | K251170 Sep 12, 2025 | 245 |
| Apr 29, 2026 | Beta Bionics, Inc. | QFG Alternate Controller Enabled Insulin Infusion Pump | K252770 Sep 29, 2025 | 212 |
| Apr 27, 2026 | Philips North America | LNH System, Nuclear Magnetic Resonance Imaging | K251397 Jun 4, 2025 | 327 |
| Apr 27, 2026 | Philips North America | LNH System, Nuclear Magnetic Resonance Imaging | K251397 Jun 4, 2025 | 327 |
| Apr 27, 2026 | Philips North America | LNH System, Nuclear Magnetic Resonance Imaging | K251808 Jul 11, 2025 | 290 |
| Apr 27, 2026 | Philips North America | LNH System, Nuclear Magnetic Resonance Imaging | K251397 Jun 4, 2025 | 327 |
| Apr 27, 2026 | Philips North America | LNH System, Nuclear Magnetic Resonance Imaging | K251397 Jun 4, 2025 | 327 |
| Apr 27, 2026 | Philips North America | LNH System, Nuclear Magnetic Resonance Imaging | K251808 Jul 11, 2025 | 290 |
| Apr 27, 2026 | Philips North America | LNH System, Nuclear Magnetic Resonance Imaging | K251397 Jun 4, 2025 | 327 |
| Apr 27, 2026 | Philips North America | LNH System, Nuclear Magnetic Resonance Imaging | K251397 Jun 4, 2025 | 327 |
| Apr 27, 2026 | Philips North America | LNH System, Nuclear Magnetic Resonance Imaging | K251808 Jul 11, 2025 | 290 |
| Apr 27, 2026 | Philips North America | LNH System, Nuclear Magnetic Resonance Imaging | K251808 Jul 11, 2025 | 290 |
| Apr 27, 2026 | Philips North America | LNH System, Nuclear Magnetic Resonance Imaging | K251397 Jun 4, 2025 | 327 |
| Apr 27, 2026 | Philips North America | LNH System, Nuclear Magnetic Resonance Imaging | K251808 Jul 11, 2025 | 290 |
| Apr 27, 2026 | Philips North America | LNH System, Nuclear Magnetic Resonance Imaging | K251397 Jun 4, 2025 | 327 |
| Apr 27, 2026 | Philips North America | LNH System, Nuclear Magnetic Resonance Imaging | K251808 Jul 11, 2025 | 290 |
| Apr 17, 2026 | Olympus Corporation of the Americas | GEI Electrosurgical, Cutting & Coagulation & Accessories | K252150 Oct 7, 2025 | 192 |
| Apr 17, 2026 | Olympus Corporation of the Americas | GEI Electrosurgical, Cutting & Coagulation & Accessories | K252150 Oct 7, 2025 | 192 |
| Apr 17, 2026 | Olympus Corporation of the Americas | GEI Electrosurgical, Cutting & Coagulation & Accessories | K252150 Oct 7, 2025 | 192 |
| Apr 17, 2026 | Olympus Corporation of the Americas | GEI Electrosurgical, Cutting & Coagulation & Accessories | K252150 Oct 7, 2025 | 192 |
| Apr 3, 2026 | Tornier, Inc | KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | K251686 Oct 30, 2025 | 155 |
| Apr 2, 2026 | Medtronic MiniMed, Inc. | QFG Alternate Controller Enabled Insulin Infusion Pump | K251032 Jul 1, 2025 | 275 |
| Mar 25, 2026 | Tandem Diabetes Care, Inc. | QFG Alternate Controller Enabled Insulin Infusion Pump | K250792 Sep 24, 2025 | 182 |
| Mar 25, 2026 | Tandem Diabetes Care, Inc. | QFG Alternate Controller Enabled Insulin Infusion Pump | K250798 May 21, 2025 | 308 |
| Mar 24, 2026 | Medtronic MiniMed, Inc. | QFG Alternate Controller Enabled Insulin Infusion Pump | K251032 Jul 1, 2025 | 266 |
| Mar 20, 2026 | Olympus Corporation of the Americas | ODC Endoscope Channel Accessory | K250949 Jul 16, 2025 | 247 |
| Mar 20, 2026 | Olympus Corporation of the Americas | ODC Endoscope Channel Accessory | K250949 Jul 16, 2025 | 247 |
| Mar 19, 2026 | Elekta, Inc. | IWB System, Radiation Therapy, Radionuclide | K250391 Jul 2, 2025 | 260 |
| Feb 17, 2026 | Stryker Corporation | NEU Marker, Radiographic, Implantable | K253888 Dec 31, 2025 | 48 |
| Feb 13, 2026 | Baxter Healthcare Corporation | FRN Pump, Infusion | K251636 Jul 28, 2025 | 200 |
| Feb 6, 2026 | Medline Industries, LP | OWQ Reprocessed Intravascular Ultrasound Catheter | K250545 Jun 5, 2025 | 246 |
| Feb 6, 2026 | Philips North America Llc | JAK System, X-Ray, Tomography, Computed | K244008 May 16, 2025 | 266 |
| Feb 6, 2026 | Philips North America Llc | JAK System, X-Ray, Tomography, Computed | K250648 Jun 27, 2025 | 224 |
| Feb 5, 2026 | Olympus Corporation of the Americas | KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | K250945 Oct 17, 2025 | 111 |
| Feb 5, 2026 | Olympus Corporation of the Americas | KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | K250945 Oct 17, 2025 | 111 |
| Feb 5, 2026 | Olympus Corporation of the Americas | KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | K250945 Oct 17, 2025 | 111 |
| Feb 5, 2026 | Olympus Corporation of the Americas | KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | K250945 Oct 17, 2025 | 111 |
| Feb 5, 2026 | Olympus Corporation of the Americas | KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | K250945 Oct 17, 2025 | 111 |
| Feb 5, 2026 | Olympus Corporation of the Americas | KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | K250945 Oct 17, 2025 | 111 |
| Feb 5, 2026 | Olympus Corporation of the Americas | KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | K250945 Oct 17, 2025 | 111 |
| Feb 5, 2026 | Olympus Corporation of the Americas | KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | K250945 Oct 17, 2025 | 111 |
| Feb 5, 2026 | Olympus Corporation of the Americas | KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | K250945 Oct 17, 2025 | 111 |
| Feb 5, 2026 | Olympus Corporation of the Americas | KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | K250945 Oct 17, 2025 | 111 |
| Feb 5, 2026 | Olympus Corporation of the Americas | KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | K250945 Oct 17, 2025 | 111 |
| Feb 5, 2026 | Olympus Corporation of the Americas | KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | K250945 Oct 17, 2025 | 111 |
| Feb 5, 2026 | Olympus Corporation of the Americas | KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | K250945 Oct 17, 2025 | 111 |
| Feb 5, 2026 | Olympus Corporation of the Americas | KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | K250945 Oct 17, 2025 | 111 |
| Feb 5, 2026 | Olympus Corporation of the Americas | KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | K250945 Oct 17, 2025 | 111 |
| Feb 5, 2026 | Olympus Corporation of the Americas | KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | K250945 Oct 17, 2025 | 111 |
| Feb 5, 2026 | Fujirebio Diagnostics, Inc. | SET Immunoassay Blood Test For Amyloid Pathology Assessment | K242706 May 16, 2025 | 265 |
| Feb 5, 2026 | Fujirebio Diagnostics, Inc. | SET Immunoassay Blood Test For Amyloid Pathology Assessment | K242706 May 16, 2025 | 265 |
| Feb 5, 2026 | Fujirebio Diagnostics, Inc. | SET Immunoassay Blood Test For Amyloid Pathology Assessment | K242706 May 16, 2025 | 265 |
| Feb 5, 2026 | Fujirebio Diagnostics, Inc. | SET Immunoassay Blood Test For Amyloid Pathology Assessment | K242706 May 16, 2025 | 265 |
| Feb 5, 2026 | Fujirebio Diagnostics, Inc. | SET Immunoassay Blood Test For Amyloid Pathology Assessment | K242706 May 16, 2025 | 265 |
| Feb 5, 2026 | Fujirebio Diagnostics, Inc. | SET Immunoassay Blood Test For Amyloid Pathology Assessment | K242706 May 16, 2025 | 265 |
| Feb 5, 2026 | Fujirebio Diagnostics, Inc. | SET Immunoassay Blood Test For Amyloid Pathology Assessment | K242706 May 16, 2025 | 265 |
| Feb 3, 2026 | Siemens Medical Solutions USA, Inc | JAK System, X-Ray, Tomography, Computed | K251061 Jul 28, 2025 | 190 |
Newest 100 shown. A link exists when the FDA recall record lists the 510(k) number.
More: Medical device recalls by FDA device class · Most recalled device types by review panel · Top 510(k) applicants in the last 12 months · Latest recalls of Class III devices · Latest recalls of Class II devices · Latest recalls of Class I devices · Companies with the most medical device recalls