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 632 of 819

FDA Devices Critical Dec 30, 2015

Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is a ventilation unit intended for the …

Draeger Medical, Inc.
FDA Devices Low Dec 30, 2015

THERMO FISHER 8 DRUG CASSETTE, Item No. MTPA-8MBAU

Ameditech Inc
FDA Devices Low Dec 30, 2015

CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12, DCC-81205-5

Ameditech Inc
FDA Devices Low Dec 30, 2015

Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU

Ameditech Inc
FDA Devices Critical Dec 30, 2015

Etest¿ PIP/TAZO/CON-4 PTC 256 -pack of 30 tests US. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-ne…

Biomerieux
FDA Devices Low Dec 30, 2015

DrugSmart Cup THC/COC/AMP//MET/OPI2/BZO, Item No. 60600D

Ameditech Inc
FDA Devices Low Dec 30, 2015

ProScreen CLIA Waived Cup with 8 Drug, Item No. PSCup-8P-W

Ameditech Inc
FDA Devices Moderate Dec 30, 2015

MicroCutter Xchange 30 Blue Cartridge, FG-025320; The MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter XCHANGE 30 Blue Curved Tip Cartridge con…

Cardica, Inc.
FDA Devices Moderate Dec 30, 2015

Green Mamba Suture Passer

Biomet, Inc.
FDA Devices Moderate Dec 30, 2015

Ingenuity Core Computed Tomography X-ray system

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

FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fastidious bacteria broth for the enriched cultivation of Neisseria spp.,…

Hardy Diagnostics
FDA Devices Low Dec 30, 2015

iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142

Ameditech Inc
FDA Devices Low Dec 30, 2015

12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP, PSD-6MTDBO300, PSD-10PPX, PSD-10MOX, 60960D, 61127D, DCC-81205-5, IMCA-10M5.

Ameditech Inc
FDA Devices Moderate Dec 30, 2015

IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 ; Material Number: M004PM4790N40; Catalog number: PM4790N4; Cardiac: The IntellaTip M…

Boston Scientific Corp
FDA Devices Moderate Dec 30, 2015

Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700.

Airways Development LLC
FDA Devices Moderate Dec 30, 2015

Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN) 10445729, IVD. --- CLASSIFICATION NAME: Test, Qualitative and…

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

DrugCheck Waived 12 Panel Cup w/Adult, Item No. DCC-81205-5

Ameditech Inc
FDA Devices Low Dec 30, 2015

ProScreen 6 Panel Dip Drug Screen, Item No. PSD-6BUPO3

Ameditech Inc
FDA Devices Moderate Dec 30, 2015

Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures.

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

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

Biomerieux
FDA Devices Low Dec 30, 2015

Immutest 11 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-11OP

Ameditech Inc
FDA Devices Low Dec 30, 2015

ProScreen 10 Panel Dip Card w/Adult, Item No. PSDA-10MO, PSDA-10MMO300, PSDA-10PPX, PSDA-10BUP, PSD-12BUP, PSD-10M, PSCupA-6MB-W, PSCup-10MMO300, P…

Ameditech Inc
FDA Devices Critical Dec 30, 2015

Boston Scientific, Chariot ST-CCV Guiding Sheath, Sterilized using ethylene oxide: Product Description Material Number (UPN) Guiding Sheath 5F, 4…

Boston Scientific Corporation
FDA Devices Moderate Dec 30, 2015

Tray Set containing multiple instruments and may contain the flexible bone awl, flexible drill and/or flexible screw driver in varying amounts depend…

Aesculap, Inc.
FDA Devices Moderate Dec 30, 2015

BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes. Product Usage: BD Vacutainer¿ tubes are used to collect, transport and process bl…

Becton Dickinson & Company
FDA Devices Low Dec 30, 2015

ProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P, PSDA-8MBO300

Ameditech Inc
FDA Devices Low Dec 30, 2015

THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU

Ameditech Inc
FDA Devices Low Dec 30, 2015

ProScreen 8 Panel Dip Card, Item No. PSD-8P

Ameditech Inc
FDA Devices Moderate Dec 30, 2015

Cardinal Health Tiny Toes; 11470-010T Infant heel warmer

Philips Electronics North America Corporation
FDA Devices Low Dec 30, 2015

ProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P, PSDA-8MBO300

Ameditech Inc
FDA Devices Moderate Dec 30, 2015

A.L.P.S. 4.0mm Cancellous Locking Screws intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions…

Biomet, Inc.
FDA Devices Low Dec 30, 2015

Immutest Cup CLIA Waived w/Adulteration, Item No. IMCA-7MT-W

Ameditech Inc
FDA Devices Low Dec 30, 2015

DrugSmart 10 Test Cup (PCP & OXY), Item No. 61020D

Ameditech Inc
FDA Devices Low Dec 30, 2015

DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.

BC Group International Inc
FDA Devices Low Dec 30, 2015

DrugSmart Dip AMP/OPI2/COC/THC/BZO Test, Item No. 30520D

Ameditech Inc
FDA Devices Low Dec 30, 2015

ProScreen 6 Panel Dip Card w/Adult (AU), Item No. PSDA-6MBAU

Ameditech Inc
FDA Devices Low Dec 30, 2015

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

Ameditech Inc
FDA Devices Moderate Dec 30, 2015

IntellaTip MiFi XP Asymmetric (N4) Curve, 7/110/2.5/8-8 OUS; Material Number: M004EPM4500N40; Catalog number: EPM4500N4; Cardiac: The Intella…

Boston Scientific Corp
FDA Devices Critical Dec 30, 2015

Etest¿ Piperacillin/tazobactam (4 ug/mL) PTc0.016-256-pack of 30 tests WW Etest¿ is a quantitative technique for determining the antimicrobial sus…

Biomerieux
FDA Devices Low Dec 30, 2015

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

Ameditech Inc
FDA Devices Moderate Dec 30, 2015

Reagent Management System (RMS) Dimension RxL Max HM STM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimens…

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

Brilliance iCT SP Computed Tomography X-ray system

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

Flexible Bone Awl; SJ607R; NON STERILE; B Braun Aesculap; Aesculap AG: These instruments are intended for use during the implantations of …

Aesculap, Inc.
FDA Devices Low Dec 30, 2015

RealityCHECK Tilt Cup 12 Panel + Adult, Item No. RC12TCA

Ameditech Inc
FDA Devices Moderate Dec 30, 2015

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

Zimmer, Inc.
FDA Devices Low Dec 30, 2015

iCup DX 11 Panel w/ Adulterant, Item No. I-DXA-1117-131

Ameditech Inc
FDA Devices Moderate Dec 30, 2015

Brilliance 64 Computed Tomography X-ray system

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

DrugSmart 9 Test Cup (BUP), Item No. 60960D

Ameditech Inc
FDA Devices Moderate Dec 30, 2015

VAPR¿ TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028)

DePuy Mitek, Inc., a Johnson & Johnson Co.
FDA Devices Low Dec 30, 2015

ProScreen CLIA Waived Cup 6 Drugs w/Adul, Item No. PSCupA-6MB-W

Ameditech 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.