PlainRecalls

Product category · Updated Jul 29, 2026

Medical Devices recalls

Medical device recalls including implants, diagnostic equipment, and surgical tools

Total recalls
40,910
Top agency
FDA Devices
Years covered
2000–2026
Check a product → All categories

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

Where Medical Devices sits among all 12 categories

Distinct recall-event inventory across every PlainRecalls product category. Medical Devices is marked; archive size reflects reporting volume, not inherent product danger.

Medical Devices vs all categories by recall count

Where this category's archive sits among every tracked product class

40,910 1st of 12 the highest of 12 categories

Categories, banded by distinct recall-event inventory

Each bar is a band; taller bars hold more categories. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · NHTSA federal recall filings · 2026-08-22

Medical Devices recalls by year

2000–2026

0 1000 2000 3000 4000 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2576 3437 2649 3803 3003 3209 2356 2247 2606 3417 2982 1787

Source: FDA · CPSC · NHTSA As of Jul 29, 2026

Severity distribution

Graded records only

recalls
Source FDA / CPSC severity classification

Recalls by issuing agency

recalls
Source PlainRecalls index of federal feeds

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 449 of 819

FDA Devices Moderate Oct 10, 2018

Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated Product Usage: The intended use of this device is a stainer for laboratory applic…

Leica Microsystems, Inc.

CPSC No agency class Oct 10, 2018

Briggs & Stratton Recalls Portable Generator Fuel Tank Replacement Caps, Due to Fire Hazard

Kelch, of Sheboygan Falls, Wis., a division of Bemis Manufacturing Company

FDA Devices Moderate Oct 3, 2018

AIIuraXperFDlO/10, System Code 722011 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including dia…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

HipLOC Hip Fracture Fixation System-Hiploc System 135¿ Plate 38 mm Barrel 3 Hole Plate Item Number: 2110-135-003 Product Usage: The HipLOC Com…

Biomet UK Ltd.

FDA Devices Moderate Oct 3, 2018

Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Usage: The Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG…

CooperSurgical, Inc.

FDA Devices Moderate Oct 3, 2018

INTEGRIS CV, System Code 722030 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnosti…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

Allura Xper FD1O C, System Code 722001 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including di…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

Poly C- DMCP-Visub(H3000), System Code 72238 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications includ…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

HipLOC Hip Fracture Fixation System-Hiploc System 140¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-140-004 Product Usage: The HipLOC Com…

Biomet UK Ltd.

FDA Devices Moderate Oct 3, 2018

Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the following product name sold under: Product Name (Model Number): A. 3.…

GE Medical Systems, LLC

FDA Devices Moderate Oct 3, 2018

VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)

Boston Scientific Corporation

FDA Devices Moderate Oct 3, 2018

Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Wide-Field Elite Pack, REF SE5420W (containing the Stellaris Elite 20 GA Vi…

Bausch & Lomb Inc

FDA Devices Moderate Oct 3, 2018

INTEGRIS SUITE, System Code 722199 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagno…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

AIIura Xper F010 DR Table, System Code 722022 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications inclu…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

Allura Xper FD2O, System Code 722006 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diag…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

INTEGRIS Allura 9 (biplane), System Code 722021 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications inc…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002

Stryker GmbH

FDA Devices Moderate Oct 3, 2018

Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Mid-Field Elite Pack, REF SE5423MV (containing the Stellaris Elite 23 GA Vi…

Bausch & Lomb Inc

FDA Devices Moderate Oct 3, 2018

Allura Xper FD2O, System Code 722012 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diag…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

HipLOC Hip Fracture Fixation System- Hiploc System 130¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-130-004 Product Usage: The HipLOC Com…

Biomet UK Ltd.

FDA Devices Moderate Oct 3, 2018

INTEGRIS Allura 15-12 (mono), System Code 722043 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications in…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

NTEGRIS Allura 9 0 FDXD, System Code 722498 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications includ…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

Allura Xper F010/10 DRTable, System Code 722019 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications inc…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Wide-Field Elite Pack, REF SE5423WV (containing the Stellaris Elite 23 GA V…

Bausch & Lomb Inc

FDA Devices Moderate Oct 3, 2018

PROPONENT Pacemaker

Boston Scientific Corporation

FDA Devices Moderate Oct 3, 2018

Allura Xper FD2O Biplane, System Code 722013 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications includ…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

AlIura Xper F010 F, System Code 722002 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including d…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

INTEGRIS Allura 9, System Code 722018 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including dia…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical …

Agfa N.V.

FDA Devices Moderate Oct 3, 2018

Allura Xper F020 DR Table, System Code 722015 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications inclu…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

Vanguard 360 Revision Knee System 75x 5mm Universal Tibial Block Augment, Model Number 185224 Intended for use in Total Knee Arthroplasty

Zimmer Biomet, Inc.

FDA Devices Moderate Oct 3, 2018

Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Wide-Field Elite Pack, REF SE5425WV (containing the Stellaris Elite 25 GA V…

Bausch & Lomb Inc

FDA Devices Moderate Oct 3, 2018

ACCOLADE Pacemaker

Boston Scientific Corporation

FDA Devices Moderate Oct 3, 2018

G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in whole blood spe…

Tosoh Bioscience Inc

FDA Devices Moderate Oct 3, 2018

Allura Xper F010 DR Table, System Code 722014 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications inclu…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

Bausch + Lomb Stellaris Elite 23 GA Vit Cutter, Model BL5627, 7500 cpm, packaged in sterile pouches, 6/shipper.

Bausch & Lomb Inc

FDA Devices Moderate Oct 3, 2018

Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packaged in sterile pouches, 6/shipper.

Bausch & Lomb Inc

FDA Devices Moderate Oct 3, 2018

da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units The da Vinci System consists of a Surgeon Console, a Patient …

Intuitive Surgical, Inc.

FDA Devices Moderate Oct 3, 2018

Cesar Powerpack-Visub(V3000), System Code 72243 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications inc…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Wide-Field Elite Pack, REF SE5523WV (containing the Stellaris Elite 23 GA Vi…

Bausch & Lomb Inc

FDA Devices Moderate Oct 3, 2018

Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Mid-Field Elite Pack, REF SE5420M (containing the Stellaris Elite 20 GA Vit…

Bausch & Lomb Inc

FDA Devices Moderate Oct 3, 2018

Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Wide-Field Elite Pack, REF SE5525WV (containing the Stellaris Elite 25 GA Vi…

Bausch & Lomb Inc

FDA Devices Moderate Oct 3, 2018

Allura Xper F020 DR Table, System Code 722023 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications inclu…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

Allura Xper F020 Biplane DR Table, System Code 722020 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applicatio…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packaged in sterile pouches, 6/shipper.

Bausch & Lomb Inc

FDA Devices Moderate Oct 3, 2018

Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221 Intended for use in Total Knee Arthroplasty

Zimmer Biomet, Inc.

FDA Devices Moderate Oct 3, 2018

Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Mid-Field Elite Pack, REF SE5525MV (containing the Stellaris Elite 25 GA Vit…

Bausch & Lomb Inc

FDA Devices Moderate Oct 3, 2018

ESSENTIO Pacemaker

Boston Scientific Corporation

FDA Devices Low Oct 3, 2018

Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35

Medtronic Vascular

FDA Devices Moderate Oct 3, 2018

Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801764

Terumo Cardiovascular Systems Corporation

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

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.