PlainRecalls

Product category · Updated Aug 19, 2026

Medical Devices recalls

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

Total recalls
41,070
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 (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 · 2026-09-01

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 1947

Source: FDA · CPSC · USDA FSIS · NHTSA As of Aug 19, 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 700 of 822

FDA Devices Moderate Nov 19, 2014

Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Ireland) Limited, IDA Business and Technology Park, Sragh, Tullamore, County…

Integra LifeSciences Corp.

FDA Devices Moderate Nov 19, 2014

GE Healthcare Varicam/VG and VG Hawkeye devices. Models H3000YA, H3000YB, H3000YC, H3000YD, H2508PA, H2508PB, H2508PC, H2508PD. Product Usage…

GE Healthcare, LLC

FDA Devices Moderate Nov 19, 2014

Integra Titan Reverse Shoulder System right and left head cutting templates, 142.5 degrees. The Reverse Shoulder System Cutting Template, 142.5 de…

Integra LifeSciences Corp.

CPSC No agency class Nov 19, 2014

AP Specialties Recalls Power Bank Chargers

FDA Drug Moderate Nov 12, 2014

CEFTAZIDIME, 2.25mg/0.1mL, Injectable, 0.2 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070

Oregon Compounding Centers, Inc. dba Creative Compounds

FDA Drug Moderate Nov 12, 2014

CITRIC ACID/GLUCONOLACTONE MAGNES CARB (RENACIDIN), 66/1.98/31.77 mg/mL, solution for irrigation, 30 mL plastic syringe, RX, Creative Compounds, Wils…

Oregon Compounding Centers, Inc. dba Creative Compounds

FDA Drug Moderate Nov 12, 2014

GANCICLOVIR -preservative free, 2mg/0.1mL, injectable, 0.1 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070

Oregon Compounding Centers, Inc. dba Creative Compounds

FDA Drug Moderate Nov 12, 2014

BEVACIZUMAB/DEXAMETHASONE, 1.25/0.5 mL, Injectable, 0.05 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070.

Oregon Compounding Centers, Inc. dba Creative Compounds

FDA Drug Moderate Nov 12, 2014

TRIESENCE, 8mg/2.0mL, Injectable, 0.2 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070

Oregon Compounding Centers, Inc. dba Creative Compounds

FDA Drug Moderate Nov 12, 2014

GANCICLOVIR, preservative free, 0.2mg/0.05mL, injectable, 0.1 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070

Oregon Compounding Centers, Inc. dba Creative Compounds

FDA Drug Moderate Nov 12, 2014

VANCOMYCIN, 1mg/0.1mL, injectable, 0.2 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070

Oregon Compounding Centers, Inc. dba Creative Compounds

FDA Drug Moderate Nov 12, 2014

AVASTIN, 1.25mg/0.5mL, injectable, 0.05 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070.

Oregon Compounding Centers, Inc. dba Creative Compounds

FDA Devices Moderate Nov 12, 2014

UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate bo…

Zimmer Surgical Inc

FDA Devices Moderate Nov 12, 2014

Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone basket is a teardrop-shaped basket with the ability to capture stones by, ope…

C.R. Bard, Inc.

FDA Devices Moderate Nov 12, 2014

Prescription eyeglass safety lenses. Vision correction

Eyemart Express Ltd

FDA Devices Moderate Nov 12, 2014

Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog Number: 6375 Product Usage: Cardioplegia Delivery System that is desi…

Terumo Cardiovascular Systems Corp

FDA Devices Moderate Nov 12, 2014

St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353

St Jude Medical

FDA Devices Critical Nov 12, 2014

Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. The TriVascular Ovation Prime Abdominal Stent Graft System is a low-pr…

Trivascular, Inc

FDA Devices Moderate Nov 12, 2014

Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A. Product Usage: The Access 2 Immunoassay system i…

Beckman Coulter Inc.

FDA Devices Moderate Nov 12, 2014

Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in Tris buffered saline with car…

Leica Microsystems, Inc.

FDA Devices Moderate Nov 12, 2014

Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 Item Number: 16110 Product Usage: This is a replacement line to…

Terumo Cardiovascular Systems Corp

FDA Devices Moderate Nov 12, 2014

CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01. Product Usage: The CADD-Solis Medication Safety Softw…

Smiths Medical ASD, Inc.

FDA Devices Moderate Nov 12, 2014

COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological

Iba Dosimetry Gmbh

FDA Devices Moderate Nov 12, 2014

UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instructions for Use Part No. A93659AB. Product Usage: The DxI 600i system…

Beckman Coulter Inc.

FDA Devices Moderate Nov 12, 2014

Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product Usage: This is a Cardiople…

Terumo Cardiovascular Systems Corp

FDA Devices Moderate Nov 12, 2014

Stryker SmartLife Large Aseptic Housing REF 7126-120-000 Rx Only The SmartLife" Aseptic Housings are designed to be used in conjunction with the…

Stryker Instruments Div. of Stryker Corporation

FDA Devices Critical Nov 12, 2014

Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid path) ,500 ml. Admixture Products and Accessories The lntra…

Baxter Healthcare Corp

FDA Devices Moderate Nov 12, 2014

Stryker SmartLife Small Aseptic Housing REF 7222-120-000 Rx Only The SmartLife" Aseptic Housings are designed to be used in conjunction with the…

Stryker Instruments Div. of Stryker Corporation

FDA Devices Moderate Nov 12, 2014

Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)

Siemens Healthcare Diagnostics, Inc

FDA Devices Moderate Nov 12, 2014

Terumo Custom Cardiovascular and Perfusion Procedure Kits Catalog Codes: Kits with a 5-digit code beginning with the digit 6: Catalog Number: 6XX…

Terumo Cardiovascular Systems Corp

FDA Devices Moderate Nov 12, 2014

Straumann Bone Level Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021.4308 Product Usage: Dental implants are intended for…

Straumann USA, LLC

FDA Devices Critical Nov 12, 2014

Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixture Products and Accessories. The lntraVia Empty Plasti…

Baxter Healthcare Corp

FDA Devices Moderate Nov 12, 2014

Cardiopulmonary bypass connector; P/N: 321334-000 DESC: CONNECTOR, 3/8 X 3/8 X 1/2 CLEAR PAY LOT: 295424 STERILE Expiration May 2019 Manufacturing Da…

Dokitz NovoSci

FDA Devices Moderate Nov 12, 2014

Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The Cardioplegia Delivery Sets are indicated for delivery of c…

Terumo Cardiovascular Systems Corp

FDA Devices Moderate Nov 12, 2014

Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System

Cynosure, Inc.

FDA Devices Moderate Nov 12, 2014

Terumo Custom Cardioplegia Delivery Sets Catalog Code: 204880 Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets-…

Terumo Cardiovascular Systems Corp

FDA Devices Moderate Nov 12, 2014

Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic Sterile if package is unopened or undamaged.

Merit Medical Systems, Inc.

FDA Food Moderate Nov 5, 2014

Good Herbs, Inc., BLOOD PRESSURE SUPPORT, 1, 4 & 8 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works

Good Herbs, Inc.

FDA Devices Moderate Nov 5, 2014

ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 67…

Siemens Healthcare Diagnostics, Inc

FDA Devices Moderate Nov 5, 2014

ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: …

Siemens Healthcare Diagnostics, Inc

FDA Devices Moderate Nov 5, 2014

Proteus 235 Proton Therapy System for cancer treatment.

Ion Beam Applications S.A.

FDA Devices Moderate Nov 5, 2014

siemens Dimension¿ Phenytoin Flex¿ Reagent Cartridge The PTN method used on the Dimension¿ clinical chemistry system is an in vitro diagnostic tes…

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Nov 5, 2014

Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag.

Coloplast Manufacturing US, LLC

FDA Devices Moderate Nov 5, 2014

ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.

Biosense Webster, Inc.

FDA Devices Moderate Nov 5, 2014

Laksell Gamma Knife Perfexion

Elekta, Inc.

FDA Devices Moderate Nov 5, 2014

Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous infusion of insulin for the treatment of in…

Animas Corporation

FDA Devices Critical Nov 5, 2014

Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide contin…

Nellcor Puritan Bennett Inc. (dba Covidien LP)

FDA Devices Moderate Nov 5, 2014

HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL and 1 x 1.6 mL. A1c Calibrators (lyophilized) contain hemoglobin and glyc…

Abbott Laboratories

FDA Devices Moderate Nov 5, 2014

Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has…

Animas Corporation

FDA Devices Moderate Nov 5, 2014

Tapered Screw-Vent Implant, MTX, 4.1mmD X 10mmL X 3.5mm Platform Part No. TSV4B10 Tapered Screw-Vent Implant, MTX, 4.1mmD X 11.5mmL X 3.5mm Platf…

Zimmer Dental 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

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.