PlainRecalls

Product category · Updated Jul 2, 2026

Medical Devices recalls

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

Total recalls
40,372
Top agency
FDA Devices
Years covered
2000–2026
Check a product → All categories

Medical Devices accounts for 40,372 recalls, about 39.7% of the federal recall archive, of which 9% of graded records are high-severity.

The FDA, CPSC and NHTSA have published 40,372 medical devices recalls between 2000 and 2026 - roughly 39.7% of the 101,704-record archive. Of the 40,372 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.

  • 40,372 total recalls
  • 39.7% of the archive
  • 9% graded high-severity
  • FDA Devices top agency

Category snapshot

Medical Devices accounts for 40,372 recalls, about 39.7% of the 101,704-record federal archive, with 3,538 graded high-severity, most issued by FDA Devices.

40,372
total recalls
9%
graded high-severity
FDA Devices
top issuing agency
2000–2026
years covered

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 1248

Source: FDA · CPSC · NHTSA As of Jul 2, 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 98 of 808

FDA Devices Moderate Oct 23, 2024

Leica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 14047033518, b) 14903050S01, c) 14903050S02, d) 14903050S03; for freezing and…

LEICA BIOSYSTEMS NUSSLOCH GMBH

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM JAPAN; the system utilizes an interactive display to provide physicians…

Boston Scientific Corporation

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US; the system utilizes an interactive display to provide physicians wi…

Boston Scientific Corporation

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST US; the system utilizes an interactive display to provide p…

Boston Scientific Corporation

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EU + ROW; the system utilizes an interactive display to provide physici…

Boston Scientific Corporation

FDA Devices Moderate Oct 23, 2024

Horizon Cardiology Hemo. Version 12.2.

CHANGE HEALTHCARE CANADA COMPANY

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST EU + RO; the system utilizes an interactive display to prov…

Boston Scientific Corporation

FDA Devices Moderate Oct 23, 2024

Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510C002, b) 1491510C003; for freezing and sectioning tissue samples

LEICA BIOSYSTEMS NUSSLOCH GMBH

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE JAPAN; the system utilizes an interactive display to provid…

Boston Scientific Corporation

FDA Devices Moderate Oct 23, 2024

Leica Biosystems Cryostat Model Number CM1950, Material Numbers: a) 14047742467, b) 1491950C1US, c) 1491950C2US, d) 1491950C3US; for freezing and se…

LEICA BIOSYSTEMS NUSSLOCH GMBH

FDA Devices Moderate Oct 23, 2024

MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B

Merit Medical Systems, Inc.

FDA Devices Moderate Oct 23, 2024

DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A

Merit Medical Systems, Inc.

FDA Devices Moderate Oct 23, 2024

Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used…

Merit Medical Systems, Inc.

FDA Devices Moderate Oct 23, 2024

The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdination of human thyroid-stimulatin…

Beckman Coulter, Inc.

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + INT Z UPGRADE JP; the system utilizes an interactive display to provi…

Boston Scientific Corporation

FDA Devices Moderate Oct 23, 2024

Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C

Merit Medical Systems, Inc.

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + MOB Z UPGRADE JP; the system utilizes an interactive display to provi…

Boston Scientific Corporation

FDA Devices Moderate Oct 23, 2024

Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device REF IN2430 Injector And Syringe, Angiographic/S…

Merit Medical Systems, Inc.

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL US; the system utilizes an interactive display to provide physicia…

Boston Scientific Corporation

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM US; the system utilizes an interactive display to provide physicians wi…

Boston Scientific Corporation

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL EU + ROW; the system utilizes an interactive display to provide ph…

Boston Scientific Corporation

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO+ BRIDGE TO INTEGRATED KIT; the system utilizes an interactive display to provide phy…

Boston Scientific Corporation

FDA Devices Moderate Oct 23, 2024

Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045

XTANT Medical Holdings, Inc

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST JAPAN; the system utilizes an interactive display to provid…

Boston Scientific Corporation

FDA Devices Moderate Oct 23, 2024

MEDLINE HEART OVERHEAD TABLE PACK, REF DYNJ0778508J

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Oct 23, 2024

Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR PURPLE Model/Catalog Number: 4329PL Product Description: ROLLING WALKER MOBILITY AID

Nova Ortho-Med Inc

FDA Devices Moderate Oct 23, 2024

BlueFIRE Inflation Device, REF: IN10140

Merit Medical Systems, Inc.

FDA Devices Moderate Oct 23, 2024

Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.

CHANGE HEALTHCARE CANADA COMPANY

FDA Devices Moderate Oct 23, 2024

Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool Torque Device REF IN2330 Injector And Syringe, Angiographic…

Merit Medical Systems, Inc.

FDA Devices Moderate Oct 23, 2024

basixTOUCH Inflation Device, REF: IN8140/A

Merit Medical Systems, Inc.

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE EU ROW; the system utilizes an interactive display to provi…

Boston Scientific Corporation

FDA Devices Moderate Oct 23, 2024

StabiliT TOUCH Syringe, REF: IN8VCF/B

Merit Medical Systems, Inc.

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE US; the system utilizes an interactive display to provide p…

Boston Scientific Corporation

FDA Devices Moderate Oct 23, 2024

IntelliSystem Inflation Device, REF: IN1525/D

Merit Medical Systems, Inc.

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM JAPAN; the system utilizes an interactive display to provide physicians…

Boston Scientific Corporation

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM EU + ROW; the system utilizes an interactive display to provide physici…

Boston Scientific Corporation

FDA Devices Moderate Oct 23, 2024

McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.

CHANGE HEALTHCARE CANADA COMPANY

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE JAPAN; the system utilizes an interactive display to provid…

Boston Scientific Corporation

FDA Devices Moderate Oct 23, 2024

Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemostat, REF G21049, 3.7 mm, Steril…

Wilson-Cook Medical Inc.

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST US; the system utilizes an interactive display to provide p…

Boston Scientific Corporation

FDA Devices Moderate Oct 23, 2024

MEDLINE OPEN HEART NIMC KIT, REF DYNJ908840

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Oct 23, 2024

Vanta Implantable Neurostimulator (INS), Model 977006

Medtronic Neuromodulation

FDA Devices Critical Oct 23, 2024

GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator

DATEX--OHMEDA, INC.

FDA Devices Moderate Oct 23, 2024

Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque DeviceREF IN2230 Injector And Syringe, Angiograp…

Merit Medical Systems, Inc.

FDA Devices Moderate Oct 23, 2024

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE US; the system utilizes an interactive display to provide p…

Boston Scientific Corporation

FDA Devices Moderate Oct 23, 2024

1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping and smoothing of bone, bone cement and teeth in…

Stryker Corporation

CPSC Moderate Oct 17, 2024

Anker Power Banks Recalled Due to Fire and Burn Hazards; Manufactured by Anker Innovations

Anker Innovations Limited, of Hong Kong, China

FDA Devices Moderate Oct 16, 2024

Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers are designed to perform as a gu…

Cook Incorporated

FDA Devices Moderate Oct 16, 2024

Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data…

Agfa Healthcare NV

FDA Devices Moderate Oct 16, 2024

Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in…

Windstone Medical Packaging, 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 Jul 2, 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 2, 2026.