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 · 2026-08-29

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 631 of 819

FDA Devices Moderate Dec 30, 2015

Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and allows a technician to take a general digital rad…

Shimadzu Medical Systems
FDA Devices Low Dec 30, 2015

11 Panel Card (OPI 300) w/Adult, Item No. 71125AA

Ameditech Inc
FDA Devices Low Dec 30, 2015

ImmuTest Cup 7-panel w/ Adulteration, Item No. IMCA-7P

Ameditech Inc
FDA Devices Low Dec 30, 2015

ProScreen CLIA Waived Cup with 6 Drugs, Item No. PSCup-6BO-W

Ameditech Inc
FDA Devices Moderate Dec 30, 2015

Enterococcus Screen Agar QUAD Plate

Becton Dickinson & Co.
FDA Devices Low Dec 30, 2015

Immutest 12 Panel Cup w/Adulteration, Item No. IMCA-11OP

Ameditech Inc
FDA Devices Low Dec 30, 2015

Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5

Ameditech Inc
FDA Devices Moderate Dec 30, 2015

Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ETTD) System.

Instratek, Incorporated
FDA Devices Low Dec 30, 2015

ProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-W

Ameditech Inc
FDA Devices Low Dec 30, 2015

10-Panel Pipette Drug Screen, Item No. PSP-10M

Ameditech Inc
FDA Devices Moderate Dec 30, 2015

Ingenuity CT Computed Tomography X-ray system

Philips Medical Systems (Cleveland) Inc
FDA Devices Critical Dec 30, 2015

Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests US. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-…

Biomerieux
FDA Devices Low Dec 30, 2015

iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013

Ameditech Inc
FDA Devices Moderate Dec 30, 2015

Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System.

DePuy Spine, Inc.
FDA Devices Low Dec 30, 2015

BZO Strip Dip Card (300ng/ml)*, Item No. 100170

Ameditech Inc
FDA Devices Moderate Dec 30, 2015

Brilliance iCT Computed Tomography X-ray system

Philips Medical Systems (Cleveland) Inc
FDA Devices Low Dec 30, 2015

1 Step 12 Panel Cup, Item No. NBCA-12M-W

Ameditech Inc
FDA Devices Low Dec 30, 2015

ProScreen 10 Drug Panel Cassette Test, Item No. PSP-10PPX

Ameditech Inc
FDA Devices Low Dec 30, 2015

DrugSmart 11 Test Cup, Item No. 61127D

Ameditech Inc
FDA Devices Low Dec 30, 2015

iCup DX 12 Panel w/ Adulterant, Item No. I-DXA-1127-023

Ameditech Inc
FDA Devices Low Dec 30, 2015

ProScreen 12 Drug Cup w/Adulteration, Item No. PSCupA-12TBU

Ameditech Inc
FDA Devices Moderate Dec 30, 2015

Flexible Screw Driver SJ706R; Non Sterile; B Braun; Aesculap; Aesculap AG These instruments are intended for use during the implantation…

Aesculap, Inc.
FDA Devices Low Dec 30, 2015

Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W

Ameditech Inc
FDA Devices Moderate Dec 30, 2015

Syngo Imaging XS is a Picture Archiving and Communication System (PACS)

Siemens Medical Solutions USA, Inc
FDA Devices Low Dec 30, 2015

ProScreen 9 Panel Cup w/Adulterants, Item No. PSCUPA-9BO300

Ameditech Inc
FDA Devices Moderate Dec 30, 2015

Vancomycin Screen Agar

Becton Dickinson & Co.
FDA Devices Low Dec 30, 2015

DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600D

Ameditech Inc
FDA Devices Low Dec 30, 2015

ProScProScreen 10 Panel Cup with Adulterants, Item No. PSCupA-10AM

Ameditech Inc
FDA Devices Moderate Dec 30, 2015

Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Single Trigger Handpiece. Rx only Made in Switzerland

Zimmer, Inc.
FDA Devices Low Dec 30, 2015

ProScreen 10 Panel Dip Card, Item No. PSD-10MOX, PSD-10MOB, PSD-10MMO300

Ameditech Inc
FDA Devices Moderate Dec 30, 2015

Flexible Drill; SJ723R; NON STERILE; B Braun Aesculap; Aesculap AG These instruments are intended for use during the implantations of the A…

Aesculap, Inc.
FDA Devices Moderate Dec 30, 2015

Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component, Precoat, Stemmed Size 3; Lot Numbe…

Zimmer Manufacturing B.V.
FDA Devices Low Dec 30, 2015

ProScreen 10 Panel Cup, Item No. PSCup-10M

Ameditech Inc
FDA Devices Moderate Dec 30, 2015

IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-8 Material Number: M004PM4500N40; Catalog number: PM4500N4; Cardiac: The IntellaTip MiFi…

Boston Scientific Corp
FDA Devices Moderate Dec 30, 2015

Dressol-X, Radiopaque D-502, NDC 11004-502-40, Dental Use Only, Active Ingredients: A.S.A. (Acetylsalicylic Acid) + Eugenol

Rainbow Specialty & Health Products
FDA Devices Low Dec 30, 2015

iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016

Ameditech Inc
FDA Devices Moderate Dec 30, 2015

Black Mamba Suture Passer

Biomet, Inc.
FDA Devices Low Dec 30, 2015

ProScreen 12 Panel Cup w/Adult., Item No. PSCupA-12M

Ameditech Inc
FDA Devices Low Dec 30, 2015

ProScreen 6 Panel Dip Card, Item No. PSCuPSD-6BUP300, PSD-6MTDBO300, PSD-6BUPO, PSD-6MBO, PSD-6MB,

Ameditech Inc
FDA Devices Low Dec 30, 2015

ProScreen 5 Panel Dip Card, Item No. PSD-12BUP

Ameditech Inc
FDA Devices Moderate Dec 30, 2015

Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35.

Terumo Medical Corp
FDA Devices Moderate Dec 30, 2015

Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medications through a needle or catheter inserted into the p…

CareFusion 303, Inc.
FDA Devices Moderate Dec 30, 2015

Ingenuity Core 128 Computed Tomography X-ray system

Philips Medical Systems (Cleveland) Inc
FDA Devices Low Dec 30, 2015

ProScreen 7 Panel Dip Card, Item No. PSD-7MPB, PSD-7MO, PSD-7M

Ameditech Inc
FDA Devices Low Dec 30, 2015

DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D DrugSmart 12 Test Cup (Multi/Single/BUP), Item No. 61205D

Ameditech Inc
FDA Devices Low Dec 30, 2015

ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU

Ameditech Inc
FDA Devices Low Dec 30, 2015

11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AA

Ameditech Inc
FDA Devices Moderate Dec 30, 2015

Reagent Management System (RMS) Dimension EXL with LM STM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimen…

Siemens Healthcare Diagnostics Inc.
FDA Devices Low Dec 30, 2015

ProScreen 5 Panel Dip Card w/Adult, Item No. PSDA-5MB300

Ameditech Inc
FDA Devices Moderate Dec 30, 2015

Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. The Guide system is comprised of a cart labelled SYN-0024 and …

Synaptive Medical, 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.