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 · 2026-08-30

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 643 of 819

FDA Devices Moderate Oct 7, 2015

Philips GoSafe Mobile Help Button; 7000MHB. Personal Emergency Response System.

Lifeline Systems, Incorporated
FDA Devices Moderate Oct 7, 2015

P/N: 9734856, SCREWDRIVER, 9734856, SOLERA STD MAST; P/N: 9734857, SCREWDRIVER, 9734857, SOLERA RDN MAST; P/N: 9734279, SCREWDRIVER 9734279 SOLERA S…

Medtronic Navigation, Inc.
FDA Devices Moderate Oct 7, 2015

Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-code…

Biosense Webster, Inc.
FDA Devices Critical Oct 7, 2015

PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degree VAR/VAL. 12/14 SLT Taper. Orthopedic hip prosthesis component.

MicroPort Orthopedics, Inc.
FDA Devices Moderate Oct 7, 2015

Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue duri…

US Endoscopy Group Inc
FDA Devices Moderate Oct 7, 2015

EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and…

Olympus Corporation of the Americas
FDA Devices Moderate Oct 7, 2015

P/N: 9735023, DRIVER 9735023 SOLERA 5.5/6.0 MAS; P/N: 9735024, DRIVER 9735024 SOLERA 5.5/6.0 MAS CAN; P/N: 9735025, DRIVER 9735025 SOLERA 5.5/6.0 R…

Medtronic Navigation, Inc.
FDA Devices Moderate Oct 7, 2015

ASP-1020 LipoTower with Aspiration Pump. Medical use.

MicroAire Surgical Instruments, LLC
FDA Devices Moderate Oct 7, 2015

Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes

Arrow International Inc
FDA Devices Moderate Sep 30, 2015

Siemens RAPIDPoint 500 Measurement Cartridge Lactate (750 tests) Part Number: 10491449 Product Usage: The RAPIDPoint 500 system is designed for …

Siemens Healthcare Diagnostics Inc
FDA Devices Moderate Sep 30, 2015

3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw. Used in ped…

OrthoPediatrics Corp
FDA Devices Moderate Sep 30, 2015

Lightspeed 16 CT

GE Healthcare
FDA Devices Moderate Sep 30, 2015

Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component

Stryker Howmedica Osteonics Corp.
FDA Devices Moderate Sep 30, 2015

PET Discovery LS

GE Healthcare
FDA Devices Moderate Sep 30, 2015

Terumo Custom Cardiovascular Procedure Kit Tubing Pack P/N: 66041-1 Terumo Cardiovascular Procedure Kits are manufactured and customized to the des…

Terumo Cardiovascular Systems Corp
FDA Devices Moderate Sep 30, 2015

Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack with FX25RE P/N: 7928-03 Terumo Cardiovascular Procedure Kits are manufactured a…

Terumo Cardiovascular Systems Corp
FDA Devices Moderate Sep 30, 2015

Terumo Custom Cardiovascular Procedure Kit X-Coated Pediatric Pack P/N: 74039-02 Terumo Cardiovascular Procedure Kits are manufactured and custom…

Terumo Cardiovascular Systems Corp
FDA Devices Moderate Sep 30, 2015

Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The Synthes Cranial Flap Tube Clamp System is intended to reattach a cranial …

Synthes (USA) Products LLC
FDA Devices Moderate Sep 30, 2015

PET Discovery ST 16

GE Healthcare
FDA Devices Moderate Sep 30, 2015

Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to observe, record and capture imag…

Fujifilm Medical Systems U.S.A., Inc.
FDA Devices Moderate Sep 30, 2015

Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75185 Terumo Cardiovascular Procedure Kits are manufactured and cust…

Terumo Cardiovascular Systems Corp
FDA Devices Moderate Sep 30, 2015

Regard Custom Surgical Pack, Item Number: 800208002; Sterile, CV0361B - CABG A&B. Used in cardiovascular surgical procedures.

Resource Optimization & Innovation Llc
FDA Devices Moderate Sep 30, 2015

Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack P/N: 74077-01 Terumo Cardiovascular Procedure Kits are manufactured and custom…

Terumo Cardiovascular Systems Corp
FDA Devices Moderate Sep 30, 2015

Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75529 Terumo Cardiovascular Procedure Kits are manufactured and cust…

Terumo Cardiovascular Systems Corp
FDA Devices Moderate Sep 30, 2015

Disposable Reflective Marker Spheres The Disposable Reflective Marker Spheres used in conjunction with a stereotaxic instrument consisting of a ri…

Brainlab AG
FDA Devices Moderate Sep 30, 2015

Siemens RAPIDPoint 500 Measurement Cartridge Lactate (100) tests Part Number: 10844813 Product Usage: The RAPIDPoint 500 system is designed for …

Siemens Healthcare Diagnostics Inc
FDA Devices Moderate Sep 30, 2015

ThruPort Knot Pusher. This device is sold individually (Model KP1) and as part of the ThruPort Valve Placement Pack (Model VPP). packaged sterile and…

Edwards Lifesciences, LLC
FDA Devices Moderate Sep 30, 2015

Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.

Fujifilm Medical Systems U.S.A., Inc.
FDA Devices Moderate Sep 30, 2015

ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer Prod…

Siemens Medical Solutions USA, Inc
FDA Devices Moderate Sep 30, 2015

Terumo Custom Cardiovascular Procedure Kit X-Coated Adult Pak P/N: 73124 Terumo Cardiovascular Procedure Kits are manufactured and customized to th…

Terumo Cardiovascular Systems Corp
FDA Devices Moderate Sep 30, 2015

Marketing brochures for the PowerPICC and PowerPICC SOLO catheters

Bard Access Systems
FDA Devices Moderate Sep 30, 2015

The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments. The Leica ASP6025 Tissue Processor is an automated system used to proces…

Leica Microsystems, Inc.
FDA Devices Moderate Sep 30, 2015

Siemens RAPIDPoint 500 Measurement Cartridge Lactate (400) tests Part Number: 10491448 Product Usage: The RAPIDPoint 500 system is designed for …

Siemens Healthcare Diagnostics Inc
FDA Devices Low Sep 30, 2015

CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Catalog number 340133 in vitro diagnostic used in Hematology: The SK3 mon…

Becton, Dickinson and Company, BD Biosciences
FDA Devices Moderate Sep 30, 2015

Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-33…

Ecolab Inc
FDA Devices Moderate Sep 30, 2015

Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures

Bien Air Dental SA
FDA Devices Moderate Sep 30, 2015

EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an Olympus video system center, light so…

Olympus America Inc.
FDA Devices Moderate Sep 30, 2015

PenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut or trim sutures and catheters up to 6Fr. Models PB-M-10, PB-M-11P, PB-…

Zien Medical Technologies, Inc
FDA Devices Moderate Sep 30, 2015

Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bon…

Synthes (USA) Products LLC
FDA Devices Moderate Sep 30, 2015

Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardiovascular surgical procedures.

Resource Optimization & Innovation Llc
FDA Devices Moderate Sep 30, 2015

MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11, Catalog No. 10714149, 10714150. Intended to manage both microbial identific…

Beckman Coulter Inc.
FDA Devices Moderate Sep 30, 2015

Siemens RAPIDPoint 500 Measurement Cartridge Lactate (250) tests Part Number: 10491447 Product Usage: The RAPIDPoint 500 system is designed for …

Siemens Healthcare Diagnostics Inc
FDA Devices Moderate Sep 23, 2015

Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems; Model numbers: 950156-01, 950156-02, 950156-03. Product Us…

Intuitive Surgical, Inc.
FDA Devices Low Sep 23, 2015

Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-150 kit includes one R1 and one R2 bottle. R1: HDPE pla…

Pointe Scientific, Inc.
FDA Devices Moderate Sep 23, 2015

Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use kit that monitors pressures when attached to pres…

Edward Lifesciences, Llc
FDA Devices Moderate Sep 23, 2015

Boston Scientific, WATCHMAN Left Atrial Appendage Closure Device with Delivery System, 21mm x 12F ( M635WU21060, WU21060, 24mm x 12F(M635WU24060, WU…

Boston Scientific Corporation
FDA Devices Critical Sep 23, 2015

Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the SynCar…

SynCardia Systems Inc.
FDA Devices Moderate Sep 23, 2015

Voyant Open Fusion Device Models: EB040 and EB040+ Product Usage: The Applied Voyant Open Fusion Device is designed for use with the Voyant Elec…

Applied Medical Resources Corp
FDA Devices Moderate Sep 23, 2015

XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing embedded with individual compressed cel…

Revmedx Inc
FDA Devices Moderate Sep 23, 2015

Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminis…

Orthovita, Inc., dBA Stryker Orthobiologics.

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.