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 · 2026-09-03

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 752 of 822

FDA Devices Moderate Nov 27, 2013

Brilliance iCT Computed Tomography X-Ray System, Product Usage: The Brilliance iCT is a Computed Tomography X-Ray System intended to produce c…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Nov 27, 2013

The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated wi…

GE Healthcare It

FDA Devices Moderate Nov 27, 2013

Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube is intended…

Spacelabs Healthcare, Llc

FDA Devices Moderate Nov 27, 2013

Fixed Offset Adapter, A-642100. The Offset Adapter is a fixed modular component which sets the tube 14.5 mm (0.57 inch) offset from the center lin…

Ossur North America Inc

FDA Devices Moderate Nov 27, 2013

VITROS Chemistry Products PHYT Slides packaged as 90 slides/pack catalog number 8298671 VITROS PHYT Slides quantitatively measure phenytoin (PHYT) c…

Ortho-Clinical Diagnostics

FDA Devices Moderate Nov 27, 2013

VITROS Chemistry Products ACET Slides, 90 slides/pack; catalog number 1037274 VITROS Chemistry Products ACET Slides quantitatively measure acetamino…

Ortho-Clinical Diagnostics

FDA Devices Moderate Nov 27, 2013

Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 9914-00-9015. and Candela Laser GentleLase Pr…

Candela Corporation

FDA Devices Moderate Nov 27, 2013

Sterile Disposable Kit ( Contains Skin Tensioner ASY-25067; Three Mark Needle Assembly ASY-25094; Nose Cone Assembly ASY-25098; Dissection 4 mm PRT-…

Restoration Robotics

FDA Devices Moderate Nov 27, 2013

VITROS Chemistry Products CHOL Slides packaged as 300 slides/pack catalog number 1669829 VITROS CHOL Slides quantitatively measure cholesterol (CHO…

Ortho-Clinical Diagnostics

FDA Devices Moderate Nov 27, 2013

Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insert…

Synthes USA HQ, Inc.

FDA Devices Moderate Nov 27, 2013

Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade is used to treat s…

Synthes USA HQ, Inc.

FDA Devices Moderate Nov 27, 2013

VITROS Chemistry Products ALC Slides, 90 slides/pack; catalog number 8046872 VITROS ALC Slides quantitatively measure ethanol (ALC) concentration in…

Ortho-Clinical Diagnostics

FDA Devices Moderate Nov 27, 2013

Ready to Use Thymo-Cide, Germicidal Detergent, containing 0.051% thymol, packaged in 1-qt. bottles. The firm name on the label is Wexford Labs, Inc.…

Wexford Labs Inc

FDA Devices Moderate Nov 27, 2013

VITROS Chemistry Products GLU Slides packaged as 300 slides/pack catalog number 1707801 VITROS GLU Slides quantitatively measure glucose (GLU) conce…

Ortho-Clinical Diagnostics

FDA Devices Moderate Nov 27, 2013

ALTRUS¿ THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 16 cm Shaft, REF 60-9520-001, STERILE -- CONMED CORPORATION 525 FRENCH RD, UTICA,…

ConMed Corporation

FDA Devices Critical Nov 27, 2013

ATTAIN HYBRID¿ Guide Wire; Models: GWR419478, GWR419488, GWR419688 The Attain Hybrid guide wire is intended to aid in the placement of Medtronic t…

Medtronic Vascular

FDA Devices Moderate Nov 27, 2013

Juggerknotless Drill Bit, REF 110003173, Sterile, Single Use Product Usage: The Juggerknotless Soft Anchors are indicated for soft tissue reatt…

Biomet, Inc.

FDA Devices Moderate Nov 27, 2013

VITROS Chemistry Products AcP Slides, 90 slides/pack; catalog number 8168122 VITROS Chemistry Products AcP Slides quantitatively measure acid phosph…

Ortho-Clinical Diagnostics

FDA Devices Moderate Nov 27, 2013

ADVIA 1800 System Software V2.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse …

Siemens Healthcare Diagnostics

FDA Devices Moderate Nov 27, 2013

VITROS Chemistry Products AMON Slides packaged as 300 slides/pack catalog number 1721869 and packaged as 90 slides/pack catalog number 1726926 VITRO…

Ortho-Clinical Diagnostics

FDA Devices Moderate Nov 27, 2013

ADVIA 2400 System Software V4.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse …

Siemens Healthcare Diagnostics

FDA Devices Moderate Nov 27, 2013

Model FL14E Rose BedsThe Rose Bed is an AC-powered adjustable long-term care bed intended for medical purposes that consists of a bed with a built-…

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Nov 27, 2013

TruSystem Surgical Table (TS7000)  Leg Section One Part Light HU Use of the Leg Section One Part Light HU is permitted only with the TRUMPF TruSy…

Trumpf Medical Systems, Inc.

FDA Devices Moderate Nov 27, 2013

VITROS Chemistry Products CK Slides packaged as 300 slides/pack catalog number 8479396 and packaged as 90 slides/pack catalog number 8478034 VITROS …

Ortho-Clinical Diagnostics

FDA Devices Critical Nov 27, 2013

THUNDER¿ Extra Support Guidewire; Models: THNDR190J, THNDR190S, THNDR300J, THNDR300S Medtronic guide wires are steerable guide wires that are use…

Medtronic Vascular

FDA Devices Critical Nov 27, 2013

CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseFocus Anesthesia Workstation with the following part numbers:…

Del Mar Reynolds Medical, Ltd.

FDA Devices Moderate Nov 27, 2013

VITROS Chemistry Products CRBM Slides packaged as 90 slides/pack catalog number 8892382

Ortho-Clinical Diagnostics

FDA Devices Moderate Nov 27, 2013

VITROS Chemistry Products TRIG Slides packaged as 300 slides/pack catalog number 1336544 and packaged as 90 slides/pack catalog number 8329930 VITRO…

Ortho-Clinical Diagnostics

FDA Devices Moderate Nov 27, 2013

VITROS Chemistry Products BUN/UREA Slides packaged as 300 slides/pack catalog number 8102204 VITROS BUN/UREA Slides quantitatively measure urea con…

Ortho-Clinical Diagnostics

FDA Devices Critical Nov 27, 2013

Zinger¿ Stainless Steel Workhorse Guidewire; Models: ZNGRLS180HJ, ZNGRLS180HS, ZNGRMS180HJ, ZNGRMS180HS, ZNGRMS180S, ZNGRS180HJ, ZNGRS180HS, ZNGRS180…

Medtronic Vascular

FDA Devices Moderate Nov 27, 2013

Centricity Perinatal and Centricity Intensive Care is intended to be used in clinical departments healthcare delivery systems such as a Labor and Del…

GE Healthcare It

FDA Devices Moderate Nov 27, 2013

VITROS Chemistry Products dHDL Slides packaged as 300 slides/pack catalog number 6801895 VITROS dHDL Slides quantitatively measure HDL cholesterol (…

Ortho-Clinical Diagnostics

FDA Devices Critical Nov 27, 2013

Cougar¿ Nitinol Workhorse Guidewire: Models: CGRLS190HJ, CGRLS190HS, CGRLS190S, CGRLS300HS, CGRLS300S. CGRXT190HJ, CGRXT190HS, CGRXT190J, CGRXT190S,…

Medtronic Vascular

FDA Devices Moderate Nov 27, 2013

VITROS Chemistry Products PHBR Slides packaged as 90 slides/pack catalog number 8221384 VITROS PHBR Slides quantitatively measure phenobarbital (PHB…

Ortho-Clinical Diagnostics

FDA Devices Moderate Nov 27, 2013

*** 1) SYMBIQ One-Channel Infuser; *** 2) SYMBIQ Two-Channel Infuser; *** E09 batteries can be identified by the "E09" that is printed beneath t…

Hospira Inc.

FDA Devices Moderate Nov 27, 2013

Polyglycolic-Lactic Acid Absorbable Surgical Suture Label reads in part "Coated VILET *** (Polyglacin 910) Suture UNDYED BRANDED V423 *** Riverpoi…

Riverpoint Medical, LLC

FDA Devices Moderate Nov 27, 2013

ALTRUS¿ THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 36 cm Shaft, REF 60-9522-001, STERILE -- CONMED CORPORATION 525 FRENCH RD, UTICA,…

ConMed Corporation

FDA Devices Critical Nov 27, 2013

The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic inf…

Hospira Inc.

FDA Devices Moderate Nov 27, 2013

VITROS Chemistry Products AST Slides packaged as 300 slides/pack catalog number 8433815 VITROS AST Slides quantitatively measure aspartate aminotran…

Ortho-Clinical Diagnostics

FDA Devices Moderate Nov 27, 2013

Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Catheter Cables, Model Numbers: D6-DR-252-RT, F6-QF-252RT, 201101, 201104, …

Stryker Sustainability Solutions

FDA Devices Moderate Nov 27, 2013

VITROS Chemistry Products LAC Slides packaged as 300 slides/pack catalog number 8433880 and packaged as 90 slides/pack catalog number 8150112 VITROS…

Ortho-Clinical Diagnostics

FDA Devices Moderate Nov 27, 2013

Stryker 1) XIA Torque Wrench 2) XIA 3 Torque Wrench 3) XIA Elegance Short Torque Wrench Manufactured by: Stryker Spine SAS Z.I. Marticot -3361…

Stryker Spine

CPSC No agency class Nov 21, 2013

Angelcare Recalls to Repair Movement and Sound Baby Monitors After Two Deaths Due to Strangulation Hazard

Angelcare Monitors Inc.®, of Quebec, Canada

CPSC No agency class Nov 21, 2013

ElliptiGO Recalls Elliptical Cycles Due to Fall Hazard

FDA Devices Moderate Nov 20, 2013

Sterrad 100NX, Product Code: 10104. Used to sterilize heat and moisture sensitive reusable medical devices.

Advanced Sterilization Products

FDA Devices Moderate Nov 20, 2013

*** 1) Plum A+ Infusion Pump; List Number: 20678; Labeled in part: PLUM A+3; for use with Hospira MedNet; *** 2) Plum A+ Infusion Pump; …

Hospira Inc.

FDA Devices Moderate Nov 20, 2013

Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<15K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide complete…

Carestream Health Inc.

FDA Devices Moderate Nov 20, 2013

Carestream Vue PACS; UNLIMITED READING LIC ADD 25K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide complete…

Carestream Health Inc.

FDA Devices Moderate Nov 20, 2013

Carestream Vue PACS; Virtual Enterprise SW StandAlone The CARESTREAM PACS is an image management system whose intended use is to provide completel…

Carestream Health Inc.

FDA Devices Moderate Nov 20, 2013

Carestream Vue PACS; Virtual PWR Reading Basic SW 8 Pack The CARESTREAM PACS is an image management system whose intended use is to provide complete…

Carestream Health 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.