Product category · Updated Aug 19, 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 (41,070 notices, 39.3% of the archive); 9% of graded records are high-severity.
The FDA, CPSC, USDA FSIS and NHTSA have published 41,070 medical devices recalls between 2000 and 2026 - roughly 39.3% of the 104,423-record archive. Among 12 product categories, that is #1 of 12. Of the 41,070 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.
- 41,070 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 41,070 recalls, about 39.3% of the 104,423-record federal archive, with 3,653 graded high-severity, most issued by FDA Devices.
- 41,070
- 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
41,070 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 · USDA FSIS · NHTSA federal recall filings · 2026-10-01
Do more recalls mean more Class I danger?
Medical Devices sits at the 100th percentile of category volume (41,070 recalls) and the 14th percentile of Class I rate (9% of agency-classified notices) among 7 categories with enough classified rows to measure, those two ranks are not interchangeable.
Read the chart, every category as text
Percentiles are within this release's classified-enough category sample. Class I % uses only agency-classified notices.
| Category | Recalls | Vol %ile | Classified | Class I | Class I % | Rate %ile |
|---|---|---|---|---|---|---|
| Medical Devices | 41,070 | 100 | 40,763 | 3,653 | 9% | 14 |
| Food | 25,513 | 86 | 25,222 | 11,676 | 46.3% | 86 |
| Drugs & Medications | 14,473 | 71 | 14,417 | 1,508 | 10.5% | 29 |
| Children & Baby Products | 4,017 | 57 | 2,483 | 352 | 14.2% | 43 |
| Dietary Supplements | 2,018 | 43 | 1,993 | 466 | 23.4% | 71 |
| Meat & Poultry | 1,672 | 29 | 1,672 | 1,145 | 68.5% | 100 |
| Cosmetics & Personal Care | 1,388 | 14 | 1,289 | 203 | 15.7% | 57 |
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,653
High severity
3,653 recalls
- Moderate
Moderate
36,361 recalls
- Lower severity 1,056
Lower severity
1,056 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,794 recalls
- FDA Drug 934
FDA Drug
934 recalls
- CPSC 307
CPSC
307 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 204 of 822
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM
Cordis US Corp
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC
Cordis US Corp
BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
Bio-Rad Laboratories, Inc.
Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal surgery
Medtronic Sofamor Danek USA Inc
TDHisto/Cyto - A software product used for managing medical information in the field of laboratories performing histology, nongynecological and gynecological cytology and autopsy activities.
Technidata S.A.
COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
Merit Medical Systems, Inc.
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MC
Cordis US Corp
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RE
Cordis US Corp
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMC
Cordis US Corp
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMC
Cordis US Corp
STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612
Diagnostica Stago, Inc.
STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612
Diagnostica Stago, Inc.
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RE
Cordis US Corp
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RE
Cordis US Corp
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 Pyxis CII Safe ES Tower Main, REF: 1116-00; BD Pyxis CII Safe ES, Desktop PC, W-LESS SCNR, BIO, REF: 107-255-01
CareFusion 303, Inc.
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RE
Cordis US Corp
STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026
Diagnostica Stago, Inc.
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMC
Cordis US Corp
Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended for open surgery. Product Code: PL771SU
Aesculap Implant Systems LLC
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 58MM Item Number: 15-2028/13
Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2230/11
Linkbio Corp.
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 50MM Item Number: 15-2028/07
Linkbio Corp.
OttLite Rechargeable UVC Disinfecting Wand
Ottlite TEchnologies, Inc.
LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2220/46
Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2230/15
Linkbio Corp.
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 55MM Item Number: 15-2028/11
Linkbio Corp.
VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents Product Code: 6802413
Ortho-Clinical Diagnostics, Inc.
DERMLITE DL4W, REF: DL4W, Rx Only MD, CE
DermLite LLC
LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2220/52
Linkbio Corp.
LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2220/40
Linkbio Corp.
LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2020/46
Linkbio Corp.
Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-functional general radiography and fluoroscopy (R/F) system
Philips North America Llc
VITROS XT 7600 Integrated System - For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents Product Code: 6844461
Ortho-Clinical Diagnostics, Inc.
Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 11206248). In vitro diagnostic use in the quantitative determination of cortisol in human serum, plasma (EDTA and lithium heparin), and urine.
Siemens Healthcare Diagnostics, Inc.
ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)- Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000
Siemens Medical Solutions USA, Inc
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2030/04
Linkbio Corp.
VITROS 5600 Integrated System - Refurbished . For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents Product Code: 6802915
Ortho-Clinical Diagnostics, Inc.
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
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13X58MM Item Number: 15-2028/16
Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2230/06
Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number: 15-2230/02
Linkbio Corp.
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 45MM Item Number: 15-2028/03
Linkbio Corp.
LINK SLED Knee System: ENDO SLED KNEE FEM COMP, Large Item Number: 15-2020/60
Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2230/08
Linkbio Corp.
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 50MM Item Number: 15-2028/05
Linkbio Corp.
Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers, including disposable surgical light handle covers are designed to fit over surgical light handles for sterile surgeon control. REF: LB53
Steris Corporation
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 50MM Item Number: 15-2028/06
Linkbio Corp.
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2030/11
Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2230/13
Linkbio Corp.
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2030/06
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
- 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 Aug 19, 2026.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC, USDA FSIS 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 Aug 19, 2026.