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 publisher.
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

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

40,910 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 · NHTSA federal recall filings · 2026-08-21

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 436 of 819

FDA Devices Moderate Dec 5, 2018

Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vitro diagnostic test for the quantitative measurement of lactate dehydroge…

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Dec 5, 2018

Solar 8000M Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.

GE Healthcare, LLC
FDA Devices Moderate Dec 5, 2018

HemoTrol Level 3- In Vitro Diagnostic Hematology quality control mixture. Catalogue number: 171.003.002 Eurotrol HemoLin is an assayed hemoglobin…

EUROTROL INC
FDA Devices Low Dec 5, 2018

Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis

Fresenius Medical Care Renal Therapies Group, LLC
FDA Devices Moderate Dec 5, 2018

NxStage PureFlow B Solution-RFP-RFP-456, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacem…

NxStage Medical, Inc.
FDA Devices Moderate Dec 5, 2018

NxStage PureFlow B Solution-RFP-401, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement …

NxStage Medical, Inc.
FDA Devices Critical Dec 5, 2018

BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2 Product Usage: BrightMatter Guide can navigate a third-party port (…

Synaptive Medical Inc
FDA Devices Moderate Dec 5, 2018

Dash 3000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.

GE Healthcare, LLC
FDA Devices Critical Dec 5, 2018

QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055120 The membrane…

Maquet Cardiovascular Us Sales, Llc
FDA Devices Moderate Dec 5, 2018

NxStage PureFlow B Solution-RFP-RFP-454, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacem…

NxStage Medical, Inc.
FDA Devices Moderate Dec 5, 2018

PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Tube Set is a single use sterile tube set used in combination with the…

WOM World of Medicine AG
FDA Devices Moderate Dec 5, 2018

NxStage PureFlow B Solution-RFP-404, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement …

NxStage Medical, Inc.
FDA Devices Moderate Dec 5, 2018

Dash 4000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.

GE Healthcare, LLC
FDA Devices Critical Dec 5, 2018

QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO 11000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055207 The membrane ox…

Maquet Cardiovascular Us Sales, Llc
FDA Devices Moderate Dec 5, 2018

Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device is intended for single use only and is provided sterile and …

Smiths Medical ASD Inc.
FDA Devices Moderate Dec 5, 2018

Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA05100 Product Usage: Recommended for use in catheterization for angiography of cardiova…

Numed Inc
FDA Devices Moderate Dec 5, 2018

PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1.0 with Hot Fix 2 Software intended to identify compounds in human samples by ionizing…

PerkinElmer Health Sciences Canada, Inc.
FDA Devices Moderate Dec 5, 2018

NxStage PureFlow B Solution-RFP-406, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement …

NxStage Medical, Inc.
FDA Devices Moderate Dec 5, 2018

Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA06100 Product Usage: Recommended for use in catheterization for angiography of cardiova…

Numed Inc
FDA Devices Moderate Dec 5, 2018

HemoTrol Level 2- In Vitro Diagnostic Hematology quality control mixture Catalogue number: 171.002.002 Eurotrol HemoLin is an assayed hemoglobin …

EUROTROL INC
FDA Devices Moderate Dec 5, 2018

NxStage PureFlow B Solution-RFP-403, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacemen…

NxStage Medical, Inc.
FDA Devices Moderate Dec 5, 2018

Solar 8000i Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.

GE Healthcare, LLC
FDA Devices Moderate Dec 5, 2018

AIA-900 Automated Immunoassay Analyzer, product code 022930 /022930R Product Usage: The AIA-900 is capable of performing three methods of immunoa…

Tosoh Bioscience Inc
FDA Devices Moderate Nov 28, 2018

PremierPro Aluminum Adjustable Walker

SVS LLC
FDA Devices Moderate Nov 28, 2018

Insulia Diabetes Management Companion

Voluntis
FDA Devices Moderate Nov 28, 2018

Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126

Zimmer Biomet, Inc.
FDA Devices Moderate Nov 28, 2018

Sedecal NOVA FA DR System. for diagnostic radiography.

Sedecal S.A.
FDA Devices Moderate Nov 28, 2018

Giraffe Incubator Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1

GE Healthcare, LLC
FDA Devices Moderate Nov 28, 2018

BD Vacutainer Urine Collection Cups, Cat. No. 364941

Becton Dickinson & Company
FDA Devices Moderate Nov 28, 2018

Vanguard Knee System -PS Open Box Femoral Right, 65 mm Item Number:183108

Zimmer Biomet, Inc.
FDA Devices Moderate Nov 28, 2018

LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10

LeMaitre Vascular, Inc.
FDA Devices Critical Nov 28, 2018

1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 MPL With MXP Software BECKMAN COULTER flow cytometer for in vitro diag…

Beckman Coulter Inc.
FDA Devices Moderate Nov 28, 2018

Panda Freestanding Warmer. Device sold under the following product names: Panda Freestanding Warmer and Panda Freestanding Warmer Generic ATO Model.…

GE Healthcare, LLC
FDA Devices Moderate Nov 28, 2018

KIT URIN CUP 16X100 8.0 CONI UA YEL, Cat. No. 364989 BD Vacutainer Urine Cup Kit with UA Tube for Midstream Specimens

Becton Dickinson & Company
FDA Devices Moderate Nov 28, 2018

DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision OMX SR Imaging System is a piece of laboratory equipment for super resol…

GE Healthcare Biosciences
FDA Devices Moderate Nov 28, 2018

Ascom Telligence Nurse Call System

Ascom (US) Inc.
FDA Devices Moderate Nov 28, 2018

Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1

GE Healthcare, LLC
FDA Devices Moderate Nov 28, 2018

Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and Giraffe Bedded Warmer. infant radiant warmer.

GE Healthcare, LLC
FDA Devices Moderate Nov 28, 2018

KIT URIN CUP PLC 16X100 10.0 UA YEL, Cat. No. 364981: Urine Collection Kit for collection and transport of urine specimens for urinalysis

Becton Dickinson & Company
FDA Devices Moderate Nov 28, 2018

AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AIA-2000 is capable of performing three methods of immunoassay: an immunoe…

Tosoh Bioscience Inc
FDA Devices Moderate Nov 28, 2018

Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda iRes Warmer and Panda iRes Bedded Warmer.

GE Healthcare, LLC
FDA Devices Moderate Nov 28, 2018

BD Vacutainer Specimen Collection Cups, Cat. No. 364975

Becton Dickinson & Company
FDA Devices Moderate Nov 28, 2018

The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System The S-ICD System is intended to p…

Boston Scientific Corporation
FDA Devices Moderate Nov 28, 2018

Minicon Clinical Sample Concentrators for In Vitro Diagnostic Use 9031 (Model: Minicon B-15) & 9051 (Model: Minicon CS-15) Minicon concentrators a…

Merck Millipore Ltd.
FDA Devices Moderate Nov 28, 2018

Panda Wall Mount warmer. Infant radiant warmer

GE Healthcare, LLC
FDA Devices Critical Nov 28, 2018

COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II Software

Beckman Coulter Inc.
FDA Devices Moderate Nov 28, 2018

VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC) Product Code: 6801728 UD…

Ortho-Clinical Diagnostics
FDA Devices Moderate Nov 28, 2018

Tosoh AIA-900 immunoassay Analyzer

Tosoh Bioscience Inc
FDA Devices Moderate Nov 28, 2018

Irrisept OR, Finished Bottle Assembly 450 ml STEP 1

Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
FDA Devices Moderate Nov 28, 2018

Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two c…

The Binding Site Group, Ltd.

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.