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 408 of 819

FDA Devices Moderate Jul 3, 2019

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: VLT600SF AIM STP

Maquet Cardiovascular Us Sales, Llc
FDA Devices Moderate Jul 3, 2019

Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 5L GP Bath Model Number: FSGPD05

Thermo Fisher Scientific (Asheville) LLC
FDA Devices Moderate Jul 3, 2019

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811910 Model:VLT600SF STP

Maquet Cardiovascular Us Sales, Llc
FDA Devices Moderate Jul 3, 2019

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229034A Model: VST60SF

Maquet Cardiovascular Us Sales, Llc
FDA Devices Moderate Jul 3, 2019

Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255-001 Product Usage: Centricity PACS-IW with Universal Viewer is a d…

GE Healthcare, LLC
FDA Devices Moderate Jul 3, 2019

TASE 500 Imaging systems

COLLINS AEROSPACE
FDA Devices Moderate Jul 3, 2019

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229036A Model:VST66SF

Maquet Cardiovascular Us Sales, Llc
FDA Devices Moderate Jul 3, 2019

RNeasy DSP FFPE Kit (48), REF 73604 - Product Usage: The RNeasy DSP FFPE Kit is a system intended for the purification of total RNA from formalin-fix…

Qiagen Sciences, Inc.
FDA Devices Moderate Jul 3, 2019

PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.

Hitachi America, Ltd., Power Systems Division
FDA Devices Critical Jul 3, 2019

enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions.

Vyaire Medical
FDA Devices Moderate Jul 3, 2019

Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.

Medtronic Inc
FDA Devices Critical Jul 3, 2019

enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood solutions.

Vyaire Medical
FDA Devices Moderate Jul 3, 2019

Thermo Scientific General Purpose Dynamic Bath Precision 5L GP Bath Model Number: TSGP05

Thermo Fisher Scientific (Asheville) LLC
FDA Devices Moderate Jul 3, 2019

Hancock II T510 Bioprosthesis, Mitral, REF T505U227 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.

Medtronic Inc
FDA Devices Moderate Jul 3, 2019

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model: VLT600SF AIM STP

Maquet Cardiovascular Us Sales, Llc
FDA Devices Low Jul 3, 2019

Replacement ECG leadwires with snap ends REF/Catalog Number Description 2106386-101 Replacement ECG Leadwire, snap, LL, AHA, 130 cm/ 51 in The …

GE Healthcare, LLC
FDA Devices Moderate Jul 3, 2019

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229035A Model:VST60DF

Maquet Cardiovascular Us Sales, Llc
FDA Devices Moderate Jul 3, 2019

Thermo Scientific General Purpose Dynamic Bath Precision 2L-Shallow GP Bath Model Number: TSGP2S

Thermo Fisher Scientific (Asheville) LLC
FDA Devices Low Jul 3, 2019

ECG leadwire sets: REF/Catalog Number Description 2106389-001 ECG Leadwire set, 5-lead, grouped, grabber, AHA, 74 cm/ 29 in 2106389-002 ECG Leadw…

GE Healthcare, LLC
FDA Devices Moderate Jul 3, 2019

Thermo Scientific General Purpose Dynamic Bath Precision 20L GP Bath Model Number: TSGP20

Thermo Fisher Scientific (Asheville) LLC
FDA Devices Moderate Jul 3, 2019

Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.

Medtronic Inc
FDA Devices Moderate Jul 3, 2019

Thermo Scientific General Purpose Dynamic Bath Precision 28L GP Bath Model Number: TSGP28

Thermo Fisher Scientific (Asheville) LLC
FDA Devices Moderate Jul 3, 2019

EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product Usage: The EPi-Sense Guided Coagulation System with VisiTrax, consist…

AtriCure, Inc.
FDA Devices Moderate Jul 3, 2019

Thermo Scientific General Purpose Dynamic Bath Precision 5 & 10L Dual GP Bath Model Number: TSGP15D

Thermo Fisher Scientific (Asheville) LLC
FDA Devices Moderate Jun 26, 2019

Arrow JACC with Chlorag+ard Technology Jugular Axillo subclavian Central Catheter Product Code: CDC 42552 JX1A

Arrow International Inc
FDA Devices Moderate Jun 26, 2019

Arrowg+ard Blue Advance JACC Product Code: CDC 42063 JX1A

Arrow International Inc
FDA Devices Moderate Jun 26, 2019

Arrow PICC with Chlorag+ard Technology Product Code: CDA 45041 HPK1A

Arrow International Inc
FDA Devices Moderate Jun 26, 2019

Arrow¿ JACC with Chlorag+ard¿ Technology Jugular Axillosubclavian Central Catheter Product Code: CDC 43063 JX1A

Arrow International Inc
FDA Devices Moderate Jun 26, 2019

Arrow¿ JACC with Chlorag+ard Technology Product Code:JR 42563 HPHNM

Arrow International Inc
FDA Devices Moderate Jun 26, 2019

EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT

Covidien LLC
FDA Devices Moderate Jun 26, 2019

Arrow¿ PICC Kit Product Code: ASK 45541 LVH1

Arrow International Inc
FDA Devices Moderate Jun 26, 2019

Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053

Randox Laboratories Ltd.
FDA Devices Moderate Jun 26, 2019

Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS" Precision Stylet Product Code: CDC 44052 VPS2

Arrow International Inc
FDA Devices Moderate Jun 26, 2019

2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)

Mako Surgical Corporation
FDA Devices Moderate Jun 26, 2019

Endotrac EPF/EGR Hook/Triangle Blade Kit, Catalogue Number 3056-1

Stryker GmbH
FDA Devices Critical Jun 26, 2019

Hudson RCI Sheridan: 1) EZ-ENDO 6.0 mm, Product Code 5-22512 2) EZ-ENDO 6.5 mm, Product Code 5-22513 3) EZ-ENDO 7.0 mm, Product Code 5-22514 4) E…

Teleflex Medical
FDA Devices Critical Jun 26, 2019

Hudson RCI Sheridan: 1) CF 6.0 mm, Product Codes: 5-10112, 5-10212 2) CF 6.5 mm, Product Codes: 5-10113, 5-10213 3) CF 7.0 mm, Product Codes: 5…

Teleflex Medical
FDA Devices Moderate Jun 26, 2019

Discovery Ml DR Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging…

GE Healthcare, LLC
FDA Devices Moderate Jun 26, 2019

LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The LEEP PRECISION INTEGRATED SYSTEM l 20V combines three components - LEEP…

CooperSurgical, Inc.
FDA Devices Moderate Jun 26, 2019

Arrow PICC Kit Product Code: ASK 45541 RWJ4

Arrow International Inc
FDA Devices Moderate Jun 26, 2019

SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT

Covidien LLC
FDA Devices Moderate Jun 26, 2019

Arrow PICC with Chlorag+ard Technology Product Code: CDA 45052 HPK1A

Arrow International Inc
FDA Devices Critical Jun 26, 2019

Hudson RCI Sheridan: 1) HVT 6.0 mm, Product Code 5-10312 2) HVT 6.5 mm, Product Code 5-10313 3) HVT 7.0 mm, Product Code 5-10314 4) HVT 7.5 mm, P…

Teleflex Medical
FDA Devices Moderate Jun 26, 2019

SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT

Covidien LLC
FDA Devices Moderate Jun 26, 2019

Arrow¿ PICC with Chlorag+ard¿ Technology Product Code: PR 45552 HPHNL

Arrow International Inc
FDA Devices Moderate Jun 26, 2019

EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT

Covidien LLC
FDA Devices Moderate Jun 26, 2019

Arrow PICC with Chlorag+ard Technology Product Code: CDA 45552 VPS2

Arrow International Inc
FDA Devices Moderate Jun 26, 2019

Arrow¿ PICC with Chlorag+ard Technology Product Code:PR 45541 HPHNM

Arrow International Inc
FDA Devices Moderate Jun 26, 2019

Arrow¿ JACC with Chlorag+ard¿ Technology Jugular Axillo subclavian Central Catheter Product Code: CDC 42563 JX1A

Arrow International Inc
FDA Devices Moderate Jun 26, 2019

Arrowg+ard Blue Advance JACC Product Code: CDC 41552 JX1A

Arrow International 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.

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.