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 664 of 819

FDA Devices Moderate Jun 17, 2015

MX 16 Slice Phase II (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland) Inc
FDA Devices Moderate Jun 17, 2015

Unilateral external fixation ankle clamp Product Usage: Unilateral external fixation for use treatment of bone conditions amenable to treatment b…

Biomet, Inc.
FDA Devices Moderate Jun 17, 2015

R3(TM) 28 MM I.D., 60 MM O.D. CONSTRAINED LINER, REF 71339160, QTY: (1), STERILE EO, Product Usage: The R3 Constrained liner Acetabular System i…

Smith & Nephew, Inc.
FDA Devices Moderate Jun 17, 2015

GEMINI TF PET/CT 64 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland) Inc
FDA Devices Moderate Jun 17, 2015

Gemini LXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland) Inc
FDA Devices Low Jun 17, 2015

RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Catheter - Intended to provide a means to access the sinus …

Acclarent, Inc.
FDA Devices Moderate Jun 17, 2015

HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-sta…

HeartWare Inc
FDA Devices Moderate Jun 17, 2015

GEMINI TF Big Bore (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland) Inc
FDA Devices Moderate Jun 17, 2015

BBL Port A Cul tubes with Swabs Sterile Pack, catalog number 221607. For patient sample collection.

Becton Dickinson & Co.
FDA Devices Low Jun 17, 2015

Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V, Standard Length Porous Plasma. Shoulder joint replacement compon…

Biomet, Inc.
FDA Devices Moderate Jun 17, 2015

Ingenuity PET/MR (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland) Inc
FDA Devices Moderate Jun 17, 2015

Vilex, Inc., FUZE 10.0 mm x 200 mm, Product # FZ100-200T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.

Vilex In Tennessee Inc
FDA Devices Moderate Jun 17, 2015

Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT,…

Gyrus Acmi, Incorporated
FDA Devices Moderate Jun 17, 2015

Brilliance CT 6 Slice Air (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland) Inc
FDA Devices Moderate Jun 17, 2015

Ingenuity Flex (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland) Inc
FDA Devices Moderate Jun 17, 2015

Ingenuity Core (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland) Inc
FDA Devices Moderate Jun 17, 2015

Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland) Inc
FDA Devices Moderate Jun 17, 2015

Assay Data Disk (ADD), All DRV versions that support product within expiry dating Automates pre-analytical and post-analytical sample and data man…

Ortho-Clinical Diagnostics
FDA Devices Low Jun 17, 2015

Biomet Cobalt-Chrome Femoral Components, 32MM MOD HEAD COCR -6MM NECK; 32MM MOD HEAD COCR -3 MM NECK; 32MM MOD HEAD COCR STD NECK ; 32MM MOD HEAD CO…

Biomet, Inc.
FDA Devices Moderate Jun 17, 2015

Gemini GXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland) Inc
FDA Devices Critical Jun 17, 2015

FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populat…

Maquet Cardiovascular Us Sales, Llc
FDA Devices Moderate Jun 17, 2015

FORTE (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland) Inc
FDA Devices Moderate Jun 17, 2015

TruFlight Select PET/CT 16-slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging sys…

Philips Medical Systems (Cleveland) Inc
FDA Devices Moderate Jun 17, 2015

EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disin…

Advanced Sterilization Products
FDA Devices Moderate Jun 17, 2015

BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland) Inc
FDA Devices Moderate Jun 17, 2015

R3(TM) 22 MM I.D., 58 MM O.D. CONSTRAINED LINER, REF 71339158, QTY: (1), STERILE EO. Product Usage: The R3 Constrained liner Acetabular System is…

Smith & Nephew, Inc.
FDA Devices Moderate Jun 17, 2015

Ingenuity CT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland) Inc
FDA Devices Moderate Jun 17, 2015

Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT,…

Gyrus Acmi, Incorporated
FDA Devices Moderate Jun 17, 2015

Precedence 16 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland) Inc
FDA Devices Moderate Jun 17, 2015

VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro d…

Ortho-Clinical Diagnostics
FDA Devices Moderate Jun 17, 2015

AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System.

Roche Diabetes Care, Inc.
FDA Devices Moderate Jun 17, 2015

AccuChek Spirit insulin infusion pump.

Roche Diabetes Care, Inc.
FDA Devices Critical Jun 17, 2015

HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205. Intended for use as a bridge to card…

HeartWare Inc
FDA Devices Moderate Jun 17, 2015

Extended Brilliance Workstation (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging syste…

Philips Medical Systems (Cleveland) Inc
FDA Devices Moderate Jun 17, 2015

Gemini 16 PET/CT System (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland) Inc
FDA Devices Low Jun 17, 2015

Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6Al-4V; Porous Plasma Uncemented, & Mallory/Head Total Hip System Size…

Biomet, Inc.
FDA Devices Critical Jun 17, 2015

HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP and 1205. Product Usage: For use …

HeartWare Inc
FDA Devices Moderate Jun 17, 2015

Brilliance CT 40 - Slices(Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland) Inc
FDA Devices Moderate Jun 17, 2015

R3(TM) 22 MM I.D., 56 MM O.D. CONSTRAINED LINER, REF 71339156, QTY: (1), STERILE EO. Product Usage: The R3 Constrained liner Acetabular System is…

Smith & Nephew, Inc.
FDA Devices Low Jun 17, 2015

MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x 12.5 MM; 80 x 15 MM Knee joint replacement prostheses components i…

Biomet, Inc.
FDA Devices Moderate Jun 17, 2015

AXIS (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland) Inc
FDA Devices Moderate Jun 17, 2015

Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX FREE, SINGLE…

Smiths Medical Asd Inc
FDA Devices Moderate Jun 17, 2015

Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for traction)

Advanced Back Technologies, Inc.
FDA Devices Moderate Jun 17, 2015

Brilliance CT Big Bore Radiology (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging syst…

Philips Medical Systems (Cleveland) Inc
FDA Devices Moderate Jun 17, 2015

BrightView XCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland) Inc
FDA Devices Moderate Jun 17, 2015

GEMINI TF Ready (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland) Inc
FDA Devices Moderate Jun 17, 2015

Extentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression table, for traction)

Advanced Back Technologies, Inc.
FDA Devices Moderate Jun 17, 2015

Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 Fr (3.5 mm) x 39.4" (100 cm) ThruPort System. Packaged steri…

Edwards Lifesciences, LLC
FDA Devices Moderate Jun 17, 2015

Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator.

ResMed Ltd.
FDA Devices Moderate Jun 17, 2015

Ingenuity Core 128 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland) 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.