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 267 of 819
Foundation Kit
Stradis Medical, LLC dba Stradis Healthcare
REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852
Limacorporate S.p.A
Optima MR450w 1.5T nuclear magnetic resonance imaging system
GE Healthcare, LLC
1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system
GE Healthcare, LLC
Herniatome, 17G x 15cm, Lumbar Type, Model Number 5091745
ADRIA SRL
Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X 4"Biopsy/Aspiration needle, 15 G Aspiration Needle (Adjus…
Bard Peripheral Vascular Inc
smiths medical portex Loss of Resistance Device, REF 100/398/000
Smiths Medical ASD Inc.
IUD Insertion Pack
Stradis Medical, LLC dba Stradis Healthcare
6.5MMX165MM CANNULATED SCREW
Smith & Nephew, Inc.
Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4"Biopsy/Aspiration needle, sterile, Qty: 10, Single Use Only, RX only. Exp. Dat…
Bard Peripheral Vascular Inc
SIGNA Architect nuclear magnetic resonance imaging system
GE Healthcare, LLC
IUD Insertion Kit
Stradis Medical, LLC dba Stradis Healthcare
Easi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths)
Kinsman Enterprises Inc
Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) with the below Model Numb…
Datascope Corp.
Atellica IM 1600 Analyzer, SMN 11066000
Siemens Healthcare Diagnostics, Inc
SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system
GE Healthcare, LLC
Herniatome, 17G x 9cm, Cervical Type, Model Number 5091749
ADRIA SRL
Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
Canon Medical System, USA, INC.
Discovery MR750w 3.0T nuclear magnetic resonance imaging system
GE Healthcare, LLC
EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
Philips Ultrasound Inc
SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051
DiaSorin Molecular LLC
medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 081-101GE c. 081-101GEE d. 081-101NE e. 081-102NE f. 081-102RE g. 08…
Smiths Medical ASD Inc.
SIGNA Voyager nuclear magnetic resonance imaging system
GE Healthcare, LLC
Kit: Central Line Dres Change 20/Cs
Medical Action Industries, Inc. 306
SIGNA Artist nuclear magnetic resonance imaging system
GE Healthcare, LLC
Discovery MR750 3.0T nuclear magnetic resonance imaging system
GE Healthcare, LLC
Tenaculum, Plastic
Stradis Medical, LLC dba Stradis Healthcare
Atellica IM 1300 Analyzer, SMN 11066001
Siemens Healthcare Diagnostics, Inc
Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex …
Medtronic Xomed, Inc.
HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight hepar…
Instrumentation Laboratory
Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex …
Medtronic Xomed, Inc.
REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845
Limacorporate S.p.A
Endometrial Biopsy Kit
Stradis Medical, LLC dba Stradis Healthcare
Standard IUD Insertion Kit
Stradis Medical, LLC dba Stradis Healthcare
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the performance of the VITROS ECi/ECiQ/3600 …
Ortho Clinical Diagnostics Inc
HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories. The assay prov…
Instrumentation Laboratory
SIGNA Premier nuclear magnetic resonance imaging system
GE Healthcare, LLC
Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex …
Medtronic Xomed, Inc.
P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641
Fort Defiance Industries, LLC
CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-21…
Smiths Medical ASD Inc.
CADD Administration Sets, Model #21-7346-24
Smiths Medical ASD Inc.
Herniatome, 17G x 15cm, Lumbar Type with with 20ga-30cm Introducer, Model Number 5091715
ADRIA SRL
HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight hepar…
Instrumentation Laboratory
Walmart Recalls Better Homes and Gardens Essential Oil Infused Aromatherapy Room Spray with Gemstones Due to Rare and Dangerous Bacteria; Two Deaths …
Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been cleared as part of the Flower …
Flower Orthopedics Corporation
ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl
National Distribution & Contracting Inc
Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A
Philips North America LLC
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Abbott Molecular, Inc.
Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
Medtronic Sofamor Danek USA Inc
Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093.
ELEKTA SOLUTIONS AB
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.