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

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 201 of 819

FDA Devices Moderate May 17, 2023

STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612

Diagnostica Stago, Inc.

FDA Devices Moderate May 17, 2023

STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612

Diagnostica Stago, Inc.

FDA Devices Critical May 17, 2023

ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RE

Cordis US Corp

FDA Devices Critical May 17, 2023

ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RE

Cordis US Corp

FDA Devices Moderate May 17, 2023

BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med ES Main Tower), REF: 352; BD Pyxis Anesthesia Station ES, REF: 327; BD Py…

CareFusion 303, Inc.

FDA Devices Critical May 17, 2023

ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RE

Cordis US Corp

FDA Devices Moderate May 17, 2023

STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026

Diagnostica Stago, Inc.

FDA Devices Critical May 17, 2023

ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMC

Cordis US Corp

FDA Devices Moderate May 17, 2023

Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagulation/ablation during endoscopic (includ…

Aesculap Implant Systems LLC

FDA Devices Moderate May 10, 2023

LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 58MM Item Number: 15-2028/13

Linkbio Corp.

FDA Devices Moderate May 10, 2023

LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2230/11

Linkbio Corp.

FDA Devices Moderate May 10, 2023

LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 50MM Item Number: 15-2028/07

Linkbio Corp.

FDA Devices Moderate May 10, 2023

OttLite Rechargeable UVC Disinfecting Wand

Ottlite TEchnologies, Inc.

FDA Devices Moderate May 10, 2023

LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2220/46

Linkbio Corp.

FDA Devices Moderate May 10, 2023

LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2230/15

Linkbio Corp.

FDA Devices Moderate May 10, 2023

LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 55MM Item Number: 15-2028/11

Linkbio Corp.

FDA Devices Moderate May 10, 2023

VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clini…

Ortho-Clinical Diagnostics, Inc.

FDA Devices Moderate May 10, 2023

DERMLITE DL4W, REF: DL4W, Rx Only MD, CE

DermLite LLC

FDA Devices Moderate May 10, 2023

LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2220/52

Linkbio Corp.

FDA Devices Moderate May 10, 2023

LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2220/40

Linkbio Corp.

FDA Devices Moderate May 10, 2023

LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2020/46

Linkbio Corp.

FDA Devices Moderate May 10, 2023

Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-functional general radiography and fluoroscopy (R/F) …

Philips North America Llc

FDA Devices Moderate May 10, 2023

VITROS XT 7600 Integrated System - For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of c…

Ortho-Clinical Diagnostics, Inc.

FDA Devices Moderate May 10, 2023

Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 11206248). In vitro diagnostic us…

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 10, 2023

ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)- Angiography systems developed for single and biplane diagnostic …

Siemens Medical Solutions USA, Inc

FDA Devices Moderate May 10, 2023

LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2030/04

Linkbio Corp.

FDA Devices Moderate May 10, 2023

VITROS 5600 Integrated System - Refurbished . For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of a…

Ortho-Clinical Diagnostics, Inc.

FDA Devices Moderate May 10, 2023

SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200

Stryker Corporation

FDA Devices Moderate May 10, 2023

LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13X58MM Item Number: 15-2028/16

Linkbio Corp.

FDA Devices Moderate May 10, 2023

LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2230/06

Linkbio Corp.

FDA Devices Moderate May 10, 2023

LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number: 15-2230/02

Linkbio Corp.

FDA Devices Moderate May 10, 2023

LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 45MM Item Number: 15-2028/03

Linkbio Corp.

FDA Devices Moderate May 10, 2023

LINK SLED Knee System: ENDO SLED KNEE FEM COMP, Large Item Number: 15-2020/60

Linkbio Corp.

FDA Devices Moderate May 10, 2023

LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2230/08

Linkbio Corp.

FDA Devices Moderate May 10, 2023

LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 50MM Item Number: 15-2028/05

Linkbio Corp.

FDA Devices Moderate May 10, 2023

Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers, including disposable surgical light handl…

Steris Corporation

FDA Devices Moderate May 10, 2023

LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 50MM Item Number: 15-2028/06

Linkbio Corp.

FDA Devices Moderate May 10, 2023

LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2030/11

Linkbio Corp.

FDA Devices Moderate May 10, 2023

LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2230/13

Linkbio Corp.

FDA Devices Moderate May 10, 2023

LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2030/06

Linkbio Corp.

FDA Devices Moderate May 10, 2023

LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2030/07

Linkbio Corp.

FDA Devices Moderate May 10, 2023

LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 55MM Item Number: 15-2028/10

Linkbio Corp.

FDA Devices Moderate May 10, 2023

LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2230/14

Linkbio Corp.

FDA Devices Moderate May 10, 2023

LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11X58MM Item Number: 15-2028/15

Linkbio Corp.

FDA Devices Moderate May 10, 2023

LINK SLED Knee System: ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2020/40

Linkbio Corp.

FDA Devices Moderate May 10, 2023

LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 45MM Item Number: 15-2028/01

Linkbio Corp.

FDA Devices Moderate May 10, 2023

Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Au…

Inpeco S.A.

FDA Devices Moderate May 10, 2023

Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 20877004S, d) 20877007S, e) 20877008S, f) 21649301S, g) 21649401S, h) 21…

Baxter Healthcare Corporation

FDA Devices Moderate May 10, 2023

LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number: 15-2030/12

Linkbio Corp.

FDA Devices Moderate May 10, 2023

LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2030/14

Linkbio 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

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.