Product category · Updated Jul 29, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices ranks #1 of 12 among PlainRecalls categories by recall count (40,910 notices, 39.3% of the archive); 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,910 medical devices recalls between 2000 and 2026 - roughly 39.3% of the 104,158-record archive. Among 12 product categories, that is #1 of 12. Of the 40,910 records graded for severity, 9% are high-severity. Most are issued by FDA Devices. Counts reflect market size and reporting activity, not a product's inherent danger.
- 40,910 total recalls
- #1 of 12 among categories
- 9% graded high-severity
- FDA Devices top agency
Category snapshot
According to PlainRecalls' category ranking (distinct recall events, same sort as /category), Medical Devices is #1 of 12 (1st of 12) with 40,910 recalls, about 39.3% of the 104,158-record federal archive, with 3,645 graded high-severity, most issued by FDA Devices.
- 40,910
- total recalls
- #1 of 12
- category rank by events
- 9%
- graded high-severity
- FDA Devices
- top issuing agency
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,645
High severity
3,645 recalls
- Moderate
Moderate
36,211 recalls
- Lower severity 1,054
Lower severity
1,054 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,635 recalls
- FDA Drug 934
FDA Drug
934 recalls
- CPSC 306
CPSC
306 recalls
- FDA Food 35
FDA Food
35 recalls
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Recalls in Medical Devices
Newest first · Page 264 of 819
INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS
Wright Medical Technology Inc
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 64 System Number: 882471 Continuous CT (CCT) is a CT or PET/CT product…
Philips North America Llc
Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the RestoreUltra (Model 37712), RestoreSensor (Model 37714), R…
Medtronic Neuromodulation
Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model N…
Siemens Medical Solutions USA, Inc
Western Oxytote DTE Digital VIPR System (with D-size cylinder) Model: MNDS-602
Western/Scott Fetzer Company
Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDU…
Medtronic Vascular, Inc.
Western Oxytote DTE Digital VIPR System (with E-size cylinder) Model: MNDS-603
Western/Scott Fetzer Company
HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.
Instrumentation Laboratory
Artis Q floor with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model N…
Siemens Medical Solutions USA, Inc
SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000
Siemens Medical Solutions USA, Inc
Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK018.10S
The Binding Site Group, Ltd.
The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and…
Intuitive Surgical, Inc.
Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
Medtronic Vascular, Inc.
Artis Q biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Mo…
Siemens Medical Solutions USA, Inc
Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number…
Siemens Medical Solutions USA, Inc
Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure …
Siemens Medical Solutions USA, Inc
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini GXL 16 Slice System Number: 882410 Continuous CT (CCT) is a CT or PET/C…
Philips North America Llc
ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17 and 8C89
Abbott Laboratories
Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600
Western/Scott Fetzer Company
SOMATOM Definition AS with software syngo.CT VB20 Model #8098027
Siemens Medical Solutions USA, Inc
Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Kit used by the Activa RC (Model 37612) implantable neurostimulator.
Medtronic Neuromodulation
Artis Q.zen biplane with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model …
Siemens Medical Solutions USA, Inc
The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chamber that holds shed mediastinal…
Atrium Medical Corporation
Artis zee biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Mo…
Siemens Medical Solutions USA, Inc
Cardioblate CryoFlex Surgical Ablation Console
Medtronic Perfusion Systems
Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and Crome implantable cardioverter …
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 16 System Number: 882470 Continuous CT (CCT) is a CT or PET/CT produ…
Philips North America Llc
SOMATOM Force with software syngo.CT VB20 Model #10742326
Siemens Medical Solutions USA, Inc
Roberts Digital VIPR System (with E-size cylinder) Model: ROC-9840
Western/Scott Fetzer Company
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - TruFlight Select PET/CT System Number: 882438 Continuous CT (CCT) is a CT or P…
Philips North America Llc
SOMATOM Definition Flash with software syngo.CT VB20 Model #10430603
Siemens Medical Solutions USA, Inc
CombiDiagnost R90 is multi-functional general R/F systems.
Philips Healthcare
ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF 01G06-11/1G06; ARCHITECT c16000 REF 03L77-01/3L77;
Abbott Laboratories
SOMATOM Confidence with software syngo.CT VB20 Model #10590100
Siemens Medical Solutions USA, Inc
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - CT Vision ACQSIM CT System Number: 728209 Continuous CT (CCT) is a CT or PET/CT p…
Philips North America Llc
Artis Q ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Mo…
Siemens Medical Solutions USA, Inc
DigitalDiagnost C90
Philips Healthcare
SOMATOM Drive with software syngo.CT VB20 Model #10431700
Siemens Medical Solutions USA, Inc
Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by the InterStim Micro (Model 97810) implantable neurostimulator.
Medtronic Neuromodulation
Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)
Philips Healthcare
SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000
Siemens Medical Solutions USA, Inc
Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
GE Healthcare, LLC
ProxiDiagnost N90 is multi-functional general R/F systems.
Philips Healthcare
Artis Q.zen floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure M…
Siemens Medical Solutions USA, Inc
BD Nexiva, 20 GA 1.00 IN (1.1 X 25 mm), 3660 ml/hr. 61ml/min; Closed IV Catheter System- Dual port -61 mL/min (3660 mL/hr)-0.5mL, REF 383536; BD Q-St…
Becton Dickinson Infusion Therapy Systems Inc.
Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE EN…
Medtronic Vascular, Inc.
Artis zee multi-purpose with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure …
Siemens Medical Solutions USA, Inc
BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR Calibrator Set is intended for the …
Bio-Rad Laboratories, Inc.
SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary …
Cordis Corporation
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075
CooperSurgical, Inc.
What to do with this
Monitoring medical devices? Start here.
- Check a specific product against the full federal archive before you use or buy it. Recall checker
- Most medical devices recalls come from FDA Devices - browse that agency's full feed. FDA Devices recalls
- Sort the whole archive by severity to see the highest-risk active recalls first. Rankings
Recall categorization follows the issuing agency's product taxonomy; always confirm specifics on the official notice.
Nearby categories
Adjacent product categories that share hazard patterns or regulatory oversight.
Data sources
- Source: FDA - openFDA Enforcement API (food, drug, and device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls
- Source: NHTSA - National Highway Traffic Safety Administration Recalls (vehicles & equipment)
Category data as of Jul 29, 2026.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Category counts and the year trend are computed across the full archive for medical devices. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of Jul 29, 2026.