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 · 2026-08-22

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 466 of 819

FDA Devices Moderate Jul 25, 2018

AesDex, LLC Cardica C-Port xA PLUS Anastomosis System. Catalog Number FG-000100. The Cardica C-Port xA PLUS Anastomosis System, delivers a seri…

AESDEX
FDA Devices Moderate Jul 25, 2018

PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416

Ethicon, Inc.
FDA Devices Moderate Jul 25, 2018

Disinfection unit UV (432332-9020-000) for the Celldiscoverer 7 microscope

Zeiss, Carl Inc
FDA Devices Moderate Jul 25, 2018

ADVANSYS TTC, Model Numbers: 181011S, 181012S, 181013S, 181014S, 181001S, 181002S, 181003S & 181004S

NewDeal SA
FDA Devices Moderate Jul 25, 2018

T2100 Micro flex Drive Treadmill, powered Product Usage: Powered exercise equipment consist of powered devices intended for medical purposes, su…

GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
FDA Devices Moderate Jul 25, 2018

Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system 45 mm Vascular/Medium, Item Code SIG45ACTAVM

COVIDIEN MEDTRONIC
FDA Devices Moderate Jul 25, 2018

MX-10 surveillance laser system Product Usage: The expected usage of the product is to facilitate observation and surveillance missions from safe…

Wescam Inc
FDA Devices Moderate Jul 25, 2018

Proteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with snout XL Product Usage: Device is designed to produce and deliver pro…

Ion Beam Applications S.A.
FDA Devices Moderate Jul 25, 2018

Dimension Vista¿ CTNI Sample Diluent, KD692, SMN# 10445205

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Jul 25, 2018

Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm Medium/Thick, Item Code SIG30AMT

COVIDIEN MEDTRONIC
FDA Devices Moderate Jul 25, 2018

Presource PBDS, Kit, No Spiro. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine…

Cardinal Health 200, LLC
FDA Devices Moderate Jul 25, 2018

PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844

Ethicon, Inc.
FDA Devices Moderate Jul 25, 2018

Reprocessed HARMONIC Ace¿ +7, 5mm Diameter Shears with Advanced Hemostasis (HARH), Item Number HARH36 Product Usage: The Reprocessed HARMONIC ACE…

Stryker Sustainability Solutions
FDA Devices Moderate Jul 25, 2018

PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688

Ethicon, Inc.
FDA Devices Moderate Jul 25, 2018

Apollo XT Suture Anchor, 5.5 x 15 Product Usage: Apollo XT Suture Anchors are intended for: Shoulder - Rotator Cuff Repair - Bankart Repair - SLA…

Valeris Medical, LLC
FDA Devices Moderate Jul 25, 2018

Endo GIA 45mm Curved Tip Articulating Vascular/Medium Reload with Tri-Staple Technology, Item Code EGIA45CTAVM

COVIDIEN MEDTRONIC
FDA Devices Moderate Jul 25, 2018

PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662

Ethicon, Inc.
FDA Devices Moderate Jul 25, 2018

Fx SOLUTIONS OFFSET HEAD CoCr 50x20, REF 106-5000 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patie…

Fx Solutions
FDA Devices Moderate Jul 25, 2018

PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748

Ethicon, Inc.
FDA Devices Moderate Jul 25, 2018

PRONOVA SUTURE BLUE 122CM M1.5, D10189

Ethicon, Inc.
FDA Devices Moderate Jul 25, 2018

Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Double Spike and no Probe, Ref ASC1221, packaged 1/box, 12 boxes/case, single us…

Cardinal Health 200, LLC
FDA Devices Moderate Jul 25, 2018

PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981

Ethicon, Inc.
FDA Devices Moderate Jul 25, 2018

PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647

Ethicon, Inc.
FDA Devices Moderate Jul 25, 2018

PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879

Ethicon, Inc.
FDA Devices Moderate Jul 25, 2018

PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746

Ethicon, Inc.
FDA Devices Moderate Jul 25, 2018

Tri-Staple 2.0 Black Intelligent Reload for use with Signia stapling system 60 mm Extra Thick, Item Code SIG60AXT

COVIDIEN MEDTRONIC
FDA Devices Moderate Jul 18, 2018

Femoral Nail, A/R T2 Femur ¿10x320 mm, Product Number 18251032S

Stryker GmbH
FDA Devices Moderate Jul 18, 2018

BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automated test for…

bioMerieux, Inc.
FDA Devices Moderate Jul 18, 2018

Ankle Arthrodesis Nail, right T2 Ankle ¿10x300mm, Product Number 18191030S

Stryker GmbH
FDA Devices Moderate Jul 18, 2018

Femoral Nail, A/R, R1500 T2 Femur ¿12x300 mm, Product Number 18281230S

Stryker GmbH
FDA Devices Moderate Jul 18, 2018

Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (…

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
FDA Devices Moderate Jul 18, 2018

Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization ther…

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
FDA Devices Moderate Jul 18, 2018

Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems

GE Medical Systems, SCS
FDA Devices Moderate Jul 18, 2018

Discovery IGS 730 Interventional Fluoroscopic X-ray Systems

GE Medical Systems, SCS
FDA Devices Moderate Jul 18, 2018

Femoral Nail, A/R, R1500 T2 Femur ¿12x360 mm, Product Number 18281236S

Stryker GmbH
FDA Devices Moderate Jul 18, 2018

Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage: Hyalomatrix is a bi-layered, sterile, flexible, and comfortable wound…

Anika Therapeutics, Inc.
FDA Devices Moderate Jul 18, 2018

Peripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-TW Product Usage: To provide real time tip location information of a…

Arrow International Inc
FDA Devices Moderate Jul 18, 2018

Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003 Product Usage: The Reliance 1227 Cart and Utensil Washer/Disinfecto…

Steris Corporation
FDA Devices Moderate Jul 18, 2018

BARD MYPICC Kit, REF CK000095B, 5F French Size, packaged 5 kits/case, Sterile, RX, For use in vascular access procedures.

Medline Industries, Inc.
FDA Devices Moderate Jul 18, 2018

VPS TipTracker Stylet Accessory, REF RHY-177-TTSAP Product Usage: To provide real time tip location information of a central venous catheter by u…

Arrow International Inc
FDA Devices Moderate Jul 18, 2018

Femoral Nail, LEFT T2 GTN ¿14x300 mm, Product Number 18501430S

Stryker GmbH
FDA Devices Moderate Jul 18, 2018

BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235, 920654335A, and 920674235A. (The differences in the reorder numbe…

Smiths Medical ASD Inc.
FDA Devices Moderate Jul 18, 2018

Percepta Quad CRT-P MRI SureScan, REF W4TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization ther…

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
FDA Devices Moderate Jul 18, 2018

Femoral Nail, RIGHT T2 GTN ¿14x460 mm, Product Number 18511446S

Stryker GmbH
FDA Devices Moderate Jul 18, 2018

Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The CrAg Lateral Flow Assay is an immunochromatographic test sys…

Immuno-Mycologics, Inc
FDA Devices Moderate Jul 18, 2018

da Vinci Xi EndoWrist Stapler 45 Reload Green, Model 48445G-03, 12 reloads/box.

Intuitive Surgical, Inc.
FDA Devices Moderate Jul 18, 2018

Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153ATG Produ…

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
FDA Devices Moderate Jul 18, 2018

VPS Rhythm ECG Accessory Pack, REF RHY-100-ECGO Product Usage: To provide real time tip location information of a central venous catheter by util…

Arrow International Inc
FDA Devices Moderate Jul 18, 2018

Ankle Arthrodesis Nail, right T2 Ankle ¿11x300mm, Product Number 18191130S

Stryker GmbH
FDA Devices Moderate Jul 18, 2018

Medtronic EnTrust Escudo D144DRG (OUS distribution) Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular a…

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

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.