ClearanceBrief
Insights

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
RecallFirmCode510(k)Days after clearance
Oct 22, 2026Medtronic MiniMed, Inc.NDC
Calculator, Drug Dose
K253512
Jan 8, 2026
287
Oct 16, 2026Think Surgical, Inc.OLO
Orthopedic Stereotaxic Instrument
K261024
Jul 24, 2026
84
Oct 15, 2026Merit Medical Systems, Inc.NEU
Marker, Radiographic, Implantable
K252892
Dec 19, 2025
300
Oct 7, 2026Mindray DS USA, Inc.MHX
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
K260098
May 20, 2026
140
Oct 5, 2026Medtronic MiniMed, Inc.QFG
Alternate Controller Enabled Insulin Infusion Pump
K253743
Mar 12, 2026
207
Sep 29, 2026Penumbra Inc.NRY
Catheter, Thrombus Retriever
K250690
Jun 10, 2026
111
Sep 25, 2026Shanghai United Imaging Healthcare Co., Ltd.JAK
System, X-Ray, Tomography, Computed
K253173
Jan 20, 2026
248
Sep 25, 2026Volcano CorpIYO
System, Imaging, Pulsed Echo, Ultrasonic
K253714
Feb 24, 2026
213
Sep 25, 2026Bard Peripheral Vascular IncKNW
Instrument, Biopsy
K252681
Dec 12, 2025
287
Sep 18, 2026Philips Ultrasound, LLCIYN
System, Imaging, Pulsed Doppler, Ultrasonic
K260123
May 27, 2026
114
Sep 18, 2026Philips Ultrasound, LLCIYN
System, Imaging, Pulsed Doppler, Ultrasonic
K260680
May 27, 2026
114
Sep 16, 2026Howmedica Osteonics Corp.NPJ
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
K252898
Dec 15, 2025
275
Sep 16, 2026Howmedica Osteonics Corp.KWZ
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
K261624
Jul 10, 2026
68
Sep 16, 2026Howmedica Osteonics Corp.KWL
Prosthesis, Hip, Hemi-, Femoral, Metal
K261624
Jul 10, 2026
68
Sep 16, 2026Wilson-Cook Medical Inc.QAU
Hemostatic Device For Endoscopic Gastrointestinal Use
K253302
Jun 2, 2026
106
Aug 5, 2026Hardy DiagnosticsJTN
Susceptibility Test Discs, Antimicrobial
K253105
Nov 20, 2025
258
Aug 3, 2026Oxos Medical IncOWB
Interventional Fluoroscopic X-Ray System
K252068
Dec 22, 2025
224
Jul 27, 2026Medtronic Perfusion SystemsDWF
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
K260195
Apr 23, 2026
95
Jul 27, 2026Medtronic Perfusion SystemsDWF
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
K260195
Apr 23, 2026
95
Jul 23, 2026Medtronic MiniMed, Inc.NDC
Calculator, Drug Dose
K253512
Jan 8, 2026
196
Jul 23, 2026Alphatec Spine, Inc.GWF
Stimulator, Electrical, Evoked Response
K252842
Jan 11, 2026
193
Jul 22, 2026Boston Scientific CorporationLLZ
System, Image Processing, Radiological
K252547
Oct 28, 2025
267
Jul 22, 2026Boston Scientific CorporationLLZ
System, Image Processing, Radiological
K260479
Mar 13, 2026
131
Jul 21, 2026PIE Medical Imaging B.V.QIH
Automated Radiological Image Processing Software
K250330
Nov 3, 2025
260
Jul 9, 2026CMR SURGICAL LIMITEDSCV
Modular Electromechanical Surgical System
K252111
Dec 16, 2025
205
Jul 9, 2026Think Surgical, Inc.OLO
Orthopedic Stereotaxic Instrument
K260010
Mar 3, 2026
128
Jun 29, 2026Medacta Usa IncPHX
Shoulder Prosthesis, Reverse Configuration
K250644
Feb 3, 2026
146
Jun 24, 2026SURGIFY MEDICAL OYHBE
Drills, Burrs, Trephines & Accessories (Simple, Powered)
K253627
Mar 26, 2026
90
Jun 24, 2026SURGIFY MEDICAL OYHBE
Drills, Burrs, Trephines & Accessories (Simple, Powered)
K253627
Mar 26, 2026
90
Jun 24, 2026SURGIFY MEDICAL OYHBE
Drills, Burrs, Trephines & Accessories (Simple, Powered)
K253627
Mar 26, 2026
90
Jun 24, 2026SURGIFY MEDICAL OYHBE
Drills, Burrs, Trephines & Accessories (Simple, Powered)
K253627
Mar 26, 2026
90
Jun 24, 2026SURGIFY MEDICAL OYHBE
Drills, Burrs, Trephines & Accessories (Simple, Powered)
K253627
Mar 26, 2026
90
Jun 24, 2026SURGIFY MEDICAL OYHBE
Drills, Burrs, Trephines & Accessories (Simple, Powered)
K253627
Mar 26, 2026
90
Jun 24, 2026SURGIFY MEDICAL OYHBE
Drills, Burrs, Trephines & Accessories (Simple, Powered)
K253627
Mar 26, 2026
90
Jun 24, 2026SURGIFY MEDICAL OYHBE
Drills, Burrs, Trephines & Accessories (Simple, Powered)
K253627
Mar 26, 2026
90
Jun 24, 2026SURGIFY MEDICAL OYHBE
Drills, Burrs, Trephines & Accessories (Simple, Powered)
K253627
Mar 26, 2026
90
Jun 24, 2026SURGIFY MEDICAL OYHBE
Drills, Burrs, Trephines & Accessories (Simple, Powered)
K253627
Mar 26, 2026
90
Jun 24, 2026SURGIFY MEDICAL OYHBE
Drills, Burrs, Trephines & Accessories (Simple, Powered)
K253627
Mar 26, 2026
90
Jun 23, 2026Acumed LLCHRS
Plate, Fixation, Bone
K251132
Jul 14, 2025
344
Jun 18, 2026Beta Bionics, Inc.QFG
Alternate Controller Enabled Insulin Infusion Pump
K252770
Sep 29, 2025
262
Jun 11, 2026Boston Scientific CorporationODC
Endoscope Channel Accessory
K252910
Oct 9, 2025
245
Jun 9, 2026The Binding Site Group, Ltd.OTA
Mass Spectrometer For Clinical Multiplex Test Systems
K250159
Oct 17, 2025
235
Jun 5, 2026GE Medical Systems, LLCOWB
Interventional Fluoroscopic X-Ray System
K251199
Dec 9, 2025
178
May 15, 2026TANGENT ENDOSCOPY, LLCFBN
Choledochoscope And Accessories, Flexible/Rigid
K251170
Sep 12, 2025
245
Apr 29, 2026Beta Bionics, Inc.QFG
Alternate Controller Enabled Insulin Infusion Pump
K252770
Sep 29, 2025
212
Apr 27, 2026Philips North AmericaLNH
System, Nuclear Magnetic Resonance Imaging
K251397
Jun 4, 2025
327
Apr 27, 2026Philips North AmericaLNH
System, Nuclear Magnetic Resonance Imaging
K251397
Jun 4, 2025
327
Apr 27, 2026Philips North AmericaLNH
System, Nuclear Magnetic Resonance Imaging
K251808
Jul 11, 2025
290
Apr 27, 2026Philips North AmericaLNH
System, Nuclear Magnetic Resonance Imaging
K251397
Jun 4, 2025
327
Apr 27, 2026Philips North AmericaLNH
System, Nuclear Magnetic Resonance Imaging
K251397
Jun 4, 2025
327
Apr 27, 2026Philips North AmericaLNH
System, Nuclear Magnetic Resonance Imaging
K251808
Jul 11, 2025
290
Apr 27, 2026Philips North AmericaLNH
System, Nuclear Magnetic Resonance Imaging
K251397
Jun 4, 2025
327
Apr 27, 2026Philips North AmericaLNH
System, Nuclear Magnetic Resonance Imaging
K251397
Jun 4, 2025
327
Apr 27, 2026Philips North AmericaLNH
System, Nuclear Magnetic Resonance Imaging
K251808
Jul 11, 2025
290
Apr 27, 2026Philips North AmericaLNH
System, Nuclear Magnetic Resonance Imaging
K251808
Jul 11, 2025
290
Apr 27, 2026Philips North AmericaLNH
System, Nuclear Magnetic Resonance Imaging
K251397
Jun 4, 2025
327
Apr 27, 2026Philips North AmericaLNH
System, Nuclear Magnetic Resonance Imaging
K251808
Jul 11, 2025
290
Apr 27, 2026Philips North AmericaLNH
System, Nuclear Magnetic Resonance Imaging
K251397
Jun 4, 2025
327
Apr 27, 2026Philips North AmericaLNH
System, Nuclear Magnetic Resonance Imaging
K251808
Jul 11, 2025
290
Apr 17, 2026Olympus Corporation of the AmericasGEI
Electrosurgical, Cutting & Coagulation & Accessories
K252150
Oct 7, 2025
192
Apr 17, 2026Olympus Corporation of the AmericasGEI
Electrosurgical, Cutting & Coagulation & Accessories
K252150
Oct 7, 2025
192
Apr 17, 2026Olympus Corporation of the AmericasGEI
Electrosurgical, Cutting & Coagulation & Accessories
K252150
Oct 7, 2025
192
Apr 17, 2026Olympus Corporation of the AmericasGEI
Electrosurgical, Cutting & Coagulation & Accessories
K252150
Oct 7, 2025
192
Apr 3, 2026Tornier, IncKWS
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
K251686
Oct 30, 2025
155
Apr 2, 2026Medtronic MiniMed, Inc.QFG
Alternate Controller Enabled Insulin Infusion Pump
K251032
Jul 1, 2025
275
Mar 25, 2026Tandem Diabetes Care, Inc.QFG
Alternate Controller Enabled Insulin Infusion Pump
K250792
Sep 24, 2025
182
Mar 25, 2026Tandem Diabetes Care, Inc.QFG
Alternate Controller Enabled Insulin Infusion Pump
K250798
May 21, 2025
308
Mar 24, 2026Medtronic MiniMed, Inc.QFG
Alternate Controller Enabled Insulin Infusion Pump
K251032
Jul 1, 2025
266
Mar 20, 2026Olympus Corporation of the AmericasODC
Endoscope Channel Accessory
K250949
Jul 16, 2025
247
Mar 20, 2026Olympus Corporation of the AmericasODC
Endoscope Channel Accessory
K250949
Jul 16, 2025
247
Mar 19, 2026Elekta, Inc.IWB
System, Radiation Therapy, Radionuclide
K250391
Jul 2, 2025
260
Feb 17, 2026Stryker CorporationNEU
Marker, Radiographic, Implantable
K253888
Dec 31, 2025
48
Feb 13, 2026Baxter Healthcare CorporationFRN
Pump, Infusion
K251636
Jul 28, 2025
200
Feb 6, 2026Medline Industries, LPOWQ
Reprocessed Intravascular Ultrasound Catheter
K250545
Jun 5, 2025
246
Feb 6, 2026Philips North America LlcJAK
System, X-Ray, Tomography, Computed
K244008
May 16, 2025
266
Feb 6, 2026Philips North America LlcJAK
System, X-Ray, Tomography, Computed
K250648
Jun 27, 2025
224
Feb 5, 2026Olympus Corporation of the AmericasKNS
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
K250945
Oct 17, 2025
111
Feb 5, 2026Olympus Corporation of the AmericasKNS
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
K250945
Oct 17, 2025
111
Feb 5, 2026Olympus Corporation of the AmericasKNS
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
K250945
Oct 17, 2025
111
Feb 5, 2026Olympus Corporation of the AmericasKNS
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
K250945
Oct 17, 2025
111
Feb 5, 2026Olympus Corporation of the AmericasKNS
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
K250945
Oct 17, 2025
111
Feb 5, 2026Olympus Corporation of the AmericasKNS
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
K250945
Oct 17, 2025
111
Feb 5, 2026Olympus Corporation of the AmericasKNS
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
K250945
Oct 17, 2025
111
Feb 5, 2026Olympus Corporation of the AmericasKNS
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
K250945
Oct 17, 2025
111
Feb 5, 2026Olympus Corporation of the AmericasKNS
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
K250945
Oct 17, 2025
111
Feb 5, 2026Olympus Corporation of the AmericasKNS
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
K250945
Oct 17, 2025
111
Feb 5, 2026Olympus Corporation of the AmericasKNS
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
K250945
Oct 17, 2025
111
Feb 5, 2026Olympus Corporation of the AmericasKNS
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
K250945
Oct 17, 2025
111
Feb 5, 2026Olympus Corporation of the AmericasKNS
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
K250945
Oct 17, 2025
111
Feb 5, 2026Olympus Corporation of the AmericasKNS
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
K250945
Oct 17, 2025
111
Feb 5, 2026Olympus Corporation of the AmericasKNS
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
K250945
Oct 17, 2025
111
Feb 5, 2026Olympus Corporation of the AmericasKNS
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
K250945
Oct 17, 2025
111
Feb 5, 2026Fujirebio Diagnostics, Inc.SET
Immunoassay Blood Test For Amyloid Pathology Assessment
K242706
May 16, 2025
265
Feb 5, 2026Fujirebio Diagnostics, Inc.SET
Immunoassay Blood Test For Amyloid Pathology Assessment
K242706
May 16, 2025
265
Feb 5, 2026Fujirebio Diagnostics, Inc.SET
Immunoassay Blood Test For Amyloid Pathology Assessment
K242706
May 16, 2025
265
Feb 5, 2026Fujirebio Diagnostics, Inc.SET
Immunoassay Blood Test For Amyloid Pathology Assessment
K242706
May 16, 2025
265
Feb 5, 2026Fujirebio Diagnostics, Inc.SET
Immunoassay Blood Test For Amyloid Pathology Assessment
K242706
May 16, 2025
265
Feb 5, 2026Fujirebio Diagnostics, Inc.SET
Immunoassay Blood Test For Amyloid Pathology Assessment
K242706
May 16, 2025
265
Feb 5, 2026Fujirebio Diagnostics, Inc.SET
Immunoassay Blood Test For Amyloid Pathology Assessment
K242706
May 16, 2025
265
Feb 3, 2026Siemens Medical Solutions USA, IncJAK
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