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 252 of 819
SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
Volcano Corporation
Signa 1.5T TwinSpeed Magnetic Resonance Imaging System
GE Healthcare, LLC
MODEL: X-RAY TV SYSSTEM SONIALVISION safire17
Shimadzu Medical Systems
Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
SA3, LLC
Coryell Memorial Hosp Total, Joint Pack - Surgical Kit
Stradis Medical, LLC dba Stradis Healthcare
DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin …
DeRoyal Industries Inc
Alinity m HBV AMP Kit (US and CE)
Abbott Molecular, Inc.
SIGNA Excite 3T. Magnetic Resonance Imaging System
GE Healthcare, LLC
First SIGN SARS-CoV-2 Antigen Test
WHPM Inc.
1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System
GE Healthcare, LLC
Revolution Apex, Revolution CT with Apex Edition
GE Healthcare, LLC
Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 523…
Brius Technologies Inc.
Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.
Hologic, Inc
MODEL: X-RAY TV SYSTEM SONIALVISION G4
Shimadzu Medical Systems
Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Number: 84164…
Draeger Medical, Inc.
DeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of th…
DeRoyal Industries Inc
Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
Philips Healthcare
Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS
Philips North America LLC
Amplatzer Steerable Delivery Sheath
Abbott
Surgicare Neuro Pack - Neurological Kit
Stradis Medical, LLC dba Stradis Healthcare
Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917; IGTCFS-65-1-JUG-TULIP G52916; IG…
Cook Medical Incorporated
BenchMark ULTRA and DISCOVERY ULTRA Instruments
Ventana Medical Systems Inc
Anterior Hip Pack - Surgical Kit
Stradis Medical, LLC dba Stradis Healthcare
Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS CARTRIDGE , (0-8 YEARS) <55 lbs/25 kg, CE 0123, NON-STERILE, Rx only…
Philips North America LLC
Total Knee Pack - Surgical Kit
Stradis Medical, LLC dba Stradis Healthcare
1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System
GE Healthcare, LLC
Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-FEM-CELECT-PT G34502; IGTCFS-65-1-JUG-CELECT-PT G34309; IGTCFS-65-1-UNI…
Cook Medical Incorporated
Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 7220…
Philips North America Llc
Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ventilation neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) …
Draeger Medical, Inc.
C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293
DRG International, Inc.
Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV Flush Only, Contents of Packa…
MEDLINE INDUSTRIES, LP - Northfield
Alinity m HBV Application Specification File (US and CE)
Abbott Molecular, Inc.
Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood oxygenation and carbon dioxide removal system used to pump blood through…
Maquet Medical Systems USA
Customized Brius Appliances (custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
Brius Technologies Inc.
Revolution CT, Revolution CT ES
GE Healthcare, LLC
Lum Lam Custom Pack - Anesthesia Kit
Stradis Medical, LLC dba Stradis Healthcare
DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the pati…
DeRoyal Industries Inc
Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
Remote Diagnostic Technologies Ltd.
Brius Pontics (components in a set of custom metal orthodontic devices);BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
Brius Technologies Inc.
Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
Siemens Medical Solutions USA, Inc.
MODEL: X-RAY R/F SYSTEM FLUOROspeed X1
Shimadzu Medical Systems
YSIO X.Pree
Siemens Medical Solutions USA, Inc
ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT iSystem with S…
Abbott Laboratories
Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded Revogene: Catalog Number 610210…
Meridian Bioscience Inc
BALLARD* Multi-Access Port Catheter, Double Swivel Y Elbow, Adult, 14 French; Sterile; Single Use
Avanos Medical, Inc.
CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
Diagnos Inc
Hanger-Bar 2P 45cm
Human Care USA, Inc.
FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA.
Edwards Lifesciences, LLC
BALLARD* Multi-Access Port (MAP) Catheter, Double Swivel Y- Adult, 16 French; Sterile; Single Use
Avanos Medical, Inc.
Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232
Howmedica Osteonics Corp.
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.