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 · 2026-08-31

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 658 of 819

FDA Devices Moderate Jul 22, 2015

Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF Surgical Instruments are designed for the specific needs of the orthopedic surge…

Musculoskeletal Transplant Foundation, Inc.
FDA Devices Moderate Jul 22, 2015

MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It support…

Elekta, Inc.
FDA Devices Moderate Jul 22, 2015

Exactech Ambassador Cervical Plate System The Exactech Ambassador Cervical Place System is intended for anterior cervical fixation (C2-T1) for the …

Exactech, Inc.
FDA Devices Moderate Jul 22, 2015

NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) system. Product Usage: Disposable reflective marker spheres a…

Northern Digital Inc.
FDA Devices Moderate Jul 22, 2015

Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear th…

Synthes, Inc.
FDA Devices Moderate Jul 22, 2015

RadiForce RX650, 6MP Color LCD Monitor, Part Code No. 0FTD1957A5, 0FTD195B5, UPC 690592037203. This product is intended to be used in displaying and…

Eizo Corporation
FDA Devices Moderate Jul 22, 2015

NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgery) system. Product Usage: Disposable reflective marker spheres are …

Northern Digital Inc.
FDA Devices Moderate Jul 22, 2015

Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision radiotherapy for lesions…

Viewray Incorporated
FDA Devices Moderate Jul 22, 2015

Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 The Alere" i Influenza A & B assay, performed on the Alere" i Instrument, is a…

Alere Scarborough, Inc. dba Binax, Inc.
FDA Devices Moderate Jul 22, 2015

RadiForce RX850, 8MP Color LCD Monitor, Part Code No. 0FTD1958A2, UPC 690592037180. This product is intended to be used in displaying and viewing di…

Eizo Corporation
FDA Devices Moderate Jul 22, 2015

Sorin Stockert Heater-Cooler 3T, 208 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.

Sorin Group USA, Inc.
FDA Devices Moderate Jul 22, 2015

Sorin Stockert Heater-Cooler 3T, 127 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.

Sorin Group USA, Inc.
FDA Devices Moderate Jul 22, 2015

IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archiving and communications system (PACS) provides an interface for the acqu…

AGFA Healthcare Corp.
FDA Devices Moderate Jul 22, 2015

Sorin Stockert Heater-Cooler 3T, 200 V / 50Hz / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.

Sorin Group USA, Inc.
FDA Devices Low Jul 22, 2015

BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR II, BD LSRFortessa,BD FACSAria, BD FACSAria II, B…

BD Biosciences, Systems & Reagents
FDA Devices Moderate Jul 22, 2015

16mm Chisel Blade; used in the LCP Anterior Ankle Arthodesis Plate System and the Hip Preservation Surgery Set. Orthopedic manual surgical instrumen…

Synthes (USA) Products LLC
FDA Devices Moderate Jul 22, 2015

A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument.

Biomet, Inc.
FDA Devices Moderate Jul 22, 2015

0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare Replacement with fan tip; 0210-318-100- Woundcare Replacement Kit; 0210…

Stryker Instruments Div. of Stryker Corporation
FDA Devices Moderate Jul 22, 2015

Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1: The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated f…

Nidek Inc
FDA Devices Moderate Jul 22, 2015

Etac Supporter toilet armrest Etac Supporter toilet armrests are foldable and have comfortable rounded grips for the hands. Supporter is simple to m…

Etac Supply Center Ab
FDA Devices Moderate Jul 22, 2015

Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent di…

Synthes (USA) Products LLC
FDA Devices Moderate Jul 22, 2015

Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care

Breas Medical AB
FDA Devices Moderate Jul 22, 2015

The FLOW-i Anesthesia System Axillary O2 and Suction Module, Device Part number: 66 79 847 FLOW-i Anesthesia System: Is indicated for administering…

Maquet Cardiovascular Us Sales, Llc
FDA Devices Moderate Jul 22, 2015

Sorin Stockert Heater-Cooler 3T, 240 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.

Sorin Group USA, Inc.
FDA Devices Moderate Jul 22, 2015

Oxford Femoral Drill Guide Lateral IM Adapter Product Usage: Drill guide. The Oxford Fixed Bearing Knee is a Partial knee replacement system c…

Biomet, Inc.
CPSC No agency class Jul 16, 2015

Reliance Worldwide Recalls Cash Acme Heatguard Temperature Actuated Flow Reducing (TAFR) Devices Due to Scald Hazard

Reliance Worldwide Corp. of Atlanta, Ga.
FDA Devices Moderate Jul 15, 2015

Lima Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch. Plastic Hub, Metal Stylet, calibrations (10BX). Integra¿ Long Epi…

Integra LifeSciences Corp. d.b.a. Integra Pain Management
FDA Devices Moderate Jul 15, 2015

Mississippi Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

Arthroscopy Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

Philips GoSafe Communicator 7000L Personal emergency response system.

Lifeline Systems, Incorporated
FDA Devices Moderate Jul 15, 2015

Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5 - 804200-002 and 804200-014; s5x - 807300-…

Volcano Corp
FDA Devices Low Jul 15, 2015

PowerPICC SOLO Catheter with Tip Location System (TLS) Stylet 4F Nurse Full Tray with Microintroducer (with Lidocain) The PowerPICC Solo catheter…

Bard Access Systems
FDA Devices Moderate Jul 15, 2015

Phleb Pack and Laser Phleb Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

A.L.P.S. Foot Locking Calcaneus Plate,Small-Right. Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management…

Biomet, Inc.
FDA Devices Moderate Jul 15, 2015

Shoulder Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

Endovenous Kit, Endo Pack and Endovenous Laser Kit - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

Vasc Custom Kit - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

Skin and Vein Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30) a measuring exercise equipment device designed to provide active and passive torque r…

BTE Technologies, Inc.
FDA Devices Moderate Jul 15, 2015

Surgical Pack and General Surgery Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

Head & Neck Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

Blepharoplasty Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

Suction Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

General Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5i -806300-020 ; s5ix/s5iz - 807400-001; …

Volcano Corp
FDA Devices Moderate Jul 15, 2015

Glaucoma Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

Knee Arthro Pack and Knee Arthro Pack II - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

Pediatric Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

Custom Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

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.