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 · 2026-09-04
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 818 of 822
TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 …
American Optisurgical Inc
PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523
Tripath Imaging, Inc.
Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection. . Product is labeled in part: "***Certain 3.25, 13***REF IOSM313…
Biomet 3i, LLC
VerifyNow P2Y12 Assay, Part Number: 85064, All reagent lots. Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the l…
Accumetrics Inc
SARNS FLEXIBLE ARTERIAL CANNULA: 7.3 MM (22 FR) 00 WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch Cannula is …
Terumo Cardiovascular Systems Corporation
NIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V~50/60 Hz - 420 W. Oxygen Concentrator.
Nidek Medical Products Inc
SARNS HIGH-FLOW AORTIC ARCH CANNULA: 5.2 MM (16 FR) 00 WITH 3/8" CONNECTOR, 7.5" (19 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicate…
Terumo Cardiovascular Systems Corporation
SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch Cannula is ind…
Terumo Cardiovascular Systems Corporation
PrepStain Syringing Pipettes 240 (Catalog #490517)
Tripath Imaging, Inc.
24FR FLEX ART CANN NON STERILE. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopul…
Terumo Cardiovascular Systems Corporation
SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 11" (28 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated…
Terumo Cardiovascular Systems Corporation
SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) 00 WITH 3/8" CONNECTOR, CM MARKING, 10" (25 CM) LONG. The Sarns High Flow Aortic Arch Cannula is i…
Terumo Cardiovascular Systems Corporation
Boston Scientific Profile Single-Use Pediatric Snare 13mm UPN Outer Box: M00562551 Inner Pouch: M00562550 The single-use Profile Polypectomy Sn…
Boston Scientific Corporation
GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-Ohmeda Aestiva/5 Anesthesia Systems.
GE Healthcare, LLC
NIDEK Medical MARK5 NUVO 8 /OCSI, 230 V~50/60Hz - 420 W. Oxygen Concentrator.
Nidek Medical Products Inc
SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 11" (28 CM) LONG, WITH XCOATING SURFACE COATING. The Sarns High Flow A…
Terumo Cardiovascular Systems Corporation
NIDEK Medical MARK5 NUVO 8 STD, 115 V~60Hz - 500W. Oxygen Concentrator.
Nidek Medical Products Inc
USA-002 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and gener…
Non-Invasive Monitoring Systems, Inc.
Boston Scientific Profile Single-Use Pediatric Snare 11mm UPN Outer Box M00562531 Inner Pouch: M00562530 , The single-use Profile Polypectomy S…
Boston Scientific Corporation
NIDEK Medical NUVO LITE MODEL 925 OCSI, 3LPM 230V - 60Hz - 280W. Oxygen Concentrator.
Nidek Medical Products Inc
Philips Multi Diagnost Eleva II with swivel cable Product Codes; 708032, 708036 Multi Diagnost Eleva with FlatDetector with swivel cable Product …
Philips Healthcare Inc.
NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W. Oxygen Concentrator.
Nidek Medical Products Inc
Boston Scientific Profile Single-Use Pediatric Snare 27mm UPN Outer Box: M00562571 Inner Pouch: M00562570 The single-use Profile Polypectomy Sn…
Boston Scientific Corporation
Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror icon Stationary Fluoroscopic system
Philips Healthcare Inc.
NIDEK Medical NUVO LITE MODEL 525 OCSI, 115V -60Hz - 330W. Oxygen Concentrator.
Nidek Medical Products Inc
NIDEK Medical MARK5 NUVO / M5C5, 115 V ~60Hz - 410 W. Oxygen Concentrator.
Nidek Medical Products Inc
Stryker Howmedica Osteonics Accolade Offset Rasp Handle Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA Stryker France ZAC Satol…
Stryker Howmedica Osteonics Corp.
NIDEK Medical NUVO LITE MODEL 925 OCSI, 230V - 50Hz - 300W. Oxygen Concentrator.
Nidek Medical Products Inc
VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care s…
Accumetrics Inc
Covidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic a…
Covidien LP
The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0. Product…
Spacelabs Healthcare, Llc
SARNS FLEXIBLE ARTERIAL CANNULA: 6.7 MM (20 FR) 00 WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch Cannula is …
Terumo Cardiovascular Systems Corporation
Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic an…
Covidien LP
PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, per the firm's explanation, that contains the PrepStain Syringing Pipet…
Tripath Imaging, Inc.
PrepStain Installation Kit (PreCoat), Catalog/Model # 490528
Tripath Imaging, Inc.
NIDEK Medical NUVO LITE MODEL 520 STD, 115V - 60Hz - 330W. Oxygen Concentrator.
Nidek Medical Products Inc
CPB CATHETER KIT- DR.VAN TRIGHT. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopul…
Terumo Cardiovascular Systems Corporation
CUSTOM CPB CATHETER KIT-DR. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonar…
Terumo Cardiovascular Systems Corporation
Covidien ROTICULATOR 30-3.5 Single Use Stapler REF# 017615 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic a…
Covidien LP
seprafilm¿ Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients…
Genzyme Corporation
HEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-544-01, Product Code 504401, Rx …
App Pharmaceuticals Llc
HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-545-01, Product Code 504501; an…
App Pharmaceuticals Llc
Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system
Philips Healthcare Inc.
Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529
Tripath Imaging, Inc.
US-001 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and genera…
Non-Invasive Monitoring Systems, Inc.
Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm¿ Imaging System is a m…
Medtronic Navigation, Inc.
Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central Venous Catheter - Catalog number CDC-42703-XP1A The mult…
Arrow International Inc
Covidien ROTICULATOR 30-4.8 Single Use Stapler REF# 017617 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic a…
Covidien LP
seprafilm¿ Single Site ADHESION BARRIER Re-order Number: 6641-01 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients unde…
Genzyme Corporation
Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer. The product is contained withi…
Ultradent Products, Inc.
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.