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
Compiled from official public sources by the editorial process.
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 374 of 819

FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.
FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.
FDA Devices Moderate Dec 18, 2019

Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.

Maquet Cardiovascular Us Sales, Llc
FDA Devices Moderate Dec 18, 2019

Healix Knotless ADV BR 4.75 Suture Anchor

DePuy Mitek, Inc., a Johnson & Johnson Co.
FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.
FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.
FDA Devices Moderate Dec 18, 2019

Radiofrequency Grounding Pad, REF RF-DGP-L

Abbott Medical
FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.
FDA Devices Moderate Dec 18, 2019

Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000

GETINGE US SALES LLC
FDA Devices Moderate Dec 18, 2019

Biopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517

Medtronic Navigation, Inc.
FDA Devices Moderate Dec 18, 2019

Ligamax 5 mm Endoscopic Multiple Clip Applier

Ethicon Endo-Surgery Inc
FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.
FDA Devices Moderate Dec 18, 2019

Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970

CP Medical Inc
FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.
FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.
FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.
FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.
FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.
FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.
FDA Devices Critical Dec 18, 2019

CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 For diagnostic and interventional vascular procedures.

Cook Inc.
FDA Devices Critical Dec 18, 2019

CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For diagnostic and interventional vascular procedures.

Cook Inc.
FDA Devices Moderate Dec 18, 2019

P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size: 10mm, (01) 00889795018182, Sterile R, Single Use Only

Paragon 28, Inc.
FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.
FDA Devices Moderate Dec 18, 2019

Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each) - Product Usage: For dentinal hypersensitivity and for the reduction o…

Young Dental Manufacturing Co, LLC
FDA Devices Moderate Dec 18, 2019

Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma C…

Roche Diagnostics Operations, Inc.
FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.
FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.
FDA Devices Moderate Dec 18, 2019

VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly

LivaNova USA Inc
FDA Devices Moderate Dec 18, 2019

BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system is for in vitro diagnostic use. Bond Polymer Refine Detection is a bio…

Leica Microsystems, Inc.
FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.
FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.
FDA Devices Moderate Dec 18, 2019

Cognision, Subject Kit (Clinical Grade), Model 3000- containing Hydro Dot brand Wave Prep cups-electroconductive cream for use with external electrod…

Neuronetrix Solutions, LLC dba Cognision
FDA Devices Moderate Dec 18, 2019

iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR Knee Replacement System is intended for use as a …

Conformis, Inc.
FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.
FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.
FDA Devices Moderate Dec 18, 2019

Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C…

The Binding Site Group, Ltd.
FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.
FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.
FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.
FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.
FDA Devices Moderate Dec 18, 2019

Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of s…

Boston Scientific Corporation
FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.
FDA Devices Moderate Dec 18, 2019

SKINFUSE Resuce Calming Complex Kit containing: SKINFUSE LIFT HG - Product Usage: The SKINFUSE Rescue Calming Complex is intend to be used to soothe…

Bellus Medical
FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.
FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.
FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.
FDA Devices Moderate Dec 18, 2019

Habib EUS RFA, 20mm electrode active tip, Material Number/UPN: 6700 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of s…

Boston Scientific Corporation
FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.
FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.
FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences 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.

Food

25,473 recalls →

Drugs & Medications

14,437 recalls →

Vehicles

8,940 recalls →

Children & Baby Products

4,007 recalls →

Household Products

3,567 recalls →

Dietary Supplements

2,016 recalls →

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.