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
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 · 2026-08-28

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 622 of 819

FDA Devices Moderate Mar 2, 2016

software for Syngo Dynamics a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and …

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Mar 2, 2016

Olympus, Model No. CF-Q160AL, flexible scope, large diameter, video colonoscope

Integrated Medical Systems Inc

FDA Devices Moderate Mar 2, 2016

Olympus, Model No. PCF-H180AL, flexible scope, large diameter, video pediatric colonoscope

Integrated Medical Systems Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548500 (XMD P/N 70-0050-116) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

NexGen CR-FLEX Option FEM NexGen CR-FLEX Precoat FEM NexGen CR-FLEX Porous FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, …

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548230 (XMD P/N 70-0050-212) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hi…

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 2, 2016

EkoSonic Endovascular System, Catalog Number 500-56112. It consists of three main components, a single use EkoSonic Endovascular Device which is c…

EKOS Corporation

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M005489350 (XMD P/N 70-0050-522) The EndoVive 3s Low Profile Balloon is intended to provide gas…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended to be used for the qualitative identification by light micro…

Leica Microsystems, Inc.

FDA Devices Moderate Mar 2, 2016

Olympus, Model No. GIF-Q160, flexible scope, large diameter, video gastroscope

Integrated Medical Systems Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548880 (XMD P/N 70-0050-720) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00549550 (XMD P/N 70-0050-B24) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548790 (XMD P/N 70-0050-E18) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

Stryker, T2 Fixation K-Wire 3 x 285mm WCH coated Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Stryker Howmedica Osteonics Corp.

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548300 (XMD P/N 70-0050-912) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00549560 (XMD P/N 70-0050-C24) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

Stryker, T2 Guidewire, Ball-Tipped, 2.5 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Stryker Howmedica Osteonics Corp.

FDA Devices Moderate Mar 2, 2016

Stryker, T2 Guidewire, Ball Tipped, 3 x 1250mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Stryker Howmedica Osteonics Corp.

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548840 (XMD P/N 70-0050-320) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

Mammomat Inspiration with Tomosynthesis functionality

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548290 (XMD P/N 70-0050-812) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

The Symbiq infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. It is intended primarily f…

Hospira Inc.

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548670 (XMD P/N 70-0050-218) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548690 (XMD P/N 70-0050-418) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548910 (XMD P/N 70-0050-A20) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548710 (XMD P/N 70-0050-618) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548580 (XMD P/N 70-0050-916) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548610 (XMD P/N 70-0050-C16) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548350 (XMD P/N 70-0050-214) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548220 (XMD P/N 70-0050-112) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

Olympus, Model No. GIF-Q180,flexible scope, large diameter, video gastroscope

Integrated Medical Systems Inc

FDA Devices Moderate Mar 2, 2016

Olympus, Model No. CF-Q160L, flexible scope, large diameter, video colonoscope

Integrated Medical Systems Inc

FDA Devices Moderate Mar 2, 2016

Stryker, T2 Guidewire, Ball-Tipped, 3x800 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Stryker Howmedica Osteonics Corp.

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number M00548430 (XMD P/N 70-0050-A14) The EndoVive 3s Low Profile Balloon is intended to provide gastr…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10459330 (BCS XP SYSTEM, C…

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Mar 2, 2016

VERSYS 7.5 INCH BEADED FC prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hi…

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548520 (XMD P/N 70-0050-316) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

Stryker, T2 K-Wire, 3.2x400mm, CoCr, Recon Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Stryker Howmedica Osteonics Corp.

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548390 (XMD P/N 70-0050-614) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548740 (XMD P/N 70-0050-918) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00549590 (XMD P/N 70-0050-F24) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548970 (XMD P/N 70-0050-G20) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548420 (XMD P/N 70-0050-914)

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

Stryker, T2 K-Wire 1.8 x 310 mm, Sterile Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Stryker Howmedica Osteonics Corp.

FDA Devices Moderate Mar 2, 2016

Metasul Head 40, 12/14, SZ M/0 total hip prosthesis - metal femoral heads Noninflammatory degenerative joint disease (NIDJD) including avascular ne…

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548860 (XMD P/N 70-0050-520) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

Olympus, Model No. PCF-Q180AL, flexible scope, large diameter, video colonoscope

Integrated Medical Systems Inc

FDA Devices Moderate Mar 2, 2016

Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer . This is a Analytical X-ray system

Olympus Scientific Solutions Americas

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548400 (XMD P/N 70-0050-714) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices 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 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.