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 · 2026-08-26

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 546 of 819

FDA Devices Moderate Apr 12, 2017

STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Turkish SRK General and Plastic Surgery: The In…

Intuitive Surgical, Inc.
FDA Devices Moderate Apr 12, 2017

OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into…

Centurion Medical Products Corporation
FDA Devices Moderate Apr 12, 2017

Covidien Curity Sodium Chloride Dressing , 6 x 6-3/4 (15.2 cm x 17.1 cm), Sterile Item Code: 3339 Curity Sodium Chloride Dressing is indicated…

Covidien LLC
FDA Devices Moderate Apr 5, 2017

Regard, Item Number: 800526003 Sterile, ET0610C - Head and Neck - Westover Hills

Resource Optimization & Innovation Llc
FDA Devices Moderate Apr 5, 2017

Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).

Merge Healthcare, Inc.
FDA Devices Moderate Apr 5, 2017

Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.

Focus Diagnostics Inc
FDA Devices Moderate Apr 5, 2017

Regard, Item Number: 800415003, Sterile, OR0484C- Shoulder System Pk - Spohn

Resource Optimization & Innovation Llc
FDA Devices Moderate Apr 5, 2017

Regard, Item Number: 800551002, Sterile, GS0640B - Lap Chole - Medical Center Santa Rosa

Resource Optimization & Innovation Llc
FDA Devices Moderate Apr 5, 2017

Regard, Item Number: 800410004, Sterile, CV0479D- Open Heart PK - Spohn

Resource Optimization & Innovation Llc
FDA Devices Moderate Apr 5, 2017

Regard, Item Number: 800567003, Sterile, GY0656C - Robotic Hysterectomy - Alamo

Resource Optimization & Innovation Llc
FDA Devices Moderate Apr 5, 2017

Regard, Item Number: 880326001, Sterile, GS0757A - Major Basin - OSU

Resource Optimization & Innovation Llc
FDA Devices Moderate Apr 5, 2017

BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit per box. Labeled Sterile"

Biomet 3i, LLC
FDA Devices Moderate Apr 5, 2017

Regard, Item Number: 800550001, Sterile, OR0639A - Hip Shoulder - Medical Center Santa Rosa

Resource Optimization & Innovation Llc
FDA Devices Moderate Apr 5, 2017

Regard, Item Number: 800558003, Sterile, OR0647C - Extremity - Childrens Santa Rosa

Resource Optimization & Innovation Llc
FDA Devices Moderate Apr 5, 2017

Regard, Item Number: 800560002, Sterile, GS0649B - Lap Chole - Childrens Santa Rosa

Resource Optimization & Innovation Llc
FDA Devices Moderate Apr 5, 2017

Regard, Item Number: 880328002, Sterile, HT0759B - Pacemaker Pk - OSU

Resource Optimization & Innovation Llc
FDA Devices Moderate Apr 5, 2017

Regard, Item Number: 800560003, Sterile, GS0649C - Lap Chole - Childrens Santa Rosa

Resource Optimization & Innovation Llc
FDA Devices Moderate Apr 5, 2017

Regard, Item Number: 800528005 Sterile, GS0612E - Lap Chole PK - Westover Hills

Resource Optimization & Innovation Llc
FDA Devices Moderate Apr 5, 2017

Regard, Item Number: 800413005, Sterile, CV0482E- Vascular PK - Spohn

Resource Optimization & Innovation Llc
FDA Devices Moderate Apr 5, 2017

Regard, Item Number: 800430005, Sterile, LD0499E - C Section Pk - Cabrini

Resource Optimization & Innovation Llc
FDA Devices Moderate Apr 5, 2017

Regard, Item Number: 800415001, Sterile, OR0484A - Shoulder System Pk - Spohn

Resource Optimization & Innovation Llc
FDA Devices Moderate Apr 5, 2017

Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids for a variety of therapies such as parenteral, ente…

Hospira Inc., A Pfizer Company
FDA Devices Moderate Apr 5, 2017

Regard, Item Number: 800535001, Sterile, LD0620A - C Section - New Braunfels

Resource Optimization & Innovation Llc
FDA Devices Moderate Apr 5, 2017

Regard, Item Number: 880328001, Sterile, HT0759A - Pacemaker Pk - OSU

Resource Optimization & Innovation Llc
FDA Devices Moderate Apr 5, 2017

Syngo.x, Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, a…

Siemens Medical Solutions USA, Inc
FDA Devices Moderate Apr 5, 2017

Regard, Item Number: 800528002 Sterile, GS0612B - Lap Chole PK - Westover Hills

Resource Optimization & Innovation Llc
FDA Devices Moderate Apr 5, 2017

Regard, Item Number: 800091002, Sterile, LD0692B - C Section - FMOL Lady of Angels

Resource Optimization & Innovation Llc
FDA Devices Moderate Apr 5, 2017

Regard, Item Number: 800417002, Sterile, GY0486B - Laparoscopy Pk - Spohn

Resource Optimization & Innovation Llc
FDA Devices Moderate Apr 5, 2017

Regard, Item Number: 800562001, Sterile, NU0651A - Neuro - Childrens Santa Rosa

Resource Optimization & Innovation Llc
FDA Devices Moderate Apr 5, 2017

Regard, Item Number: 800557001, Sterile, LD0646A - C Section - Childrens Santa Rosa

Resource Optimization & Innovation Llc
FDA Devices Moderate Apr 5, 2017

Regard, Item Number: 800414003, Sterile, OR0483C - Total Joint Pk - Spohn

Resource Optimization & Innovation Llc
FDA Devices Critical Apr 5, 2017

HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536…

Philips North America, LLC
FDA Devices Moderate Apr 5, 2017

Regard, Item Number: 800508004, Sterile, LD0586D - C Section - Jasper

Resource Optimization & Innovation Llc
FDA Devices Moderate Apr 5, 2017

Regard, Item Number: 800414002, Sterile, OR0483B- Total Joint Pk - Spohn

Resource Optimization & Innovation Llc
FDA Devices Moderate Apr 5, 2017

Regard, Item Number: 800562002, Sterile, NU0651B - Neuro - Childrens Santa Rosa

Resource Optimization & Innovation Llc
FDA Devices Moderate Apr 5, 2017

Regard, Item Number: 800326002, Sterile, GS0757B - Major Basin - OSU

Resource Optimization & Innovation Llc
FDA Devices Moderate Apr 5, 2017

AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis

AGFA Healthcare Corp.
FDA Devices Moderate Apr 5, 2017

Regard, Item Number: 800419002, Sterile, GY0488B - D&C Pk - Spohn

Resource Optimization & Innovation Llc
FDA Devices Moderate Apr 5, 2017

Regard, Item Number: 800524003, Sterile, LD0608C - C Section - Westover Hills

Resource Optimization & Innovation Llc
FDA Devices Moderate Apr 5, 2017

Regard, Item Number: 800410003, Sterile, CV0479C - Open Heart PK - Spohn

Resource Optimization & Innovation Llc
FDA Devices Moderate Apr 5, 2017

Regard, Item Number: 800533001, Sterile, GS0606A - Abdominal Pk - Westover Hills

Resource Optimization & Innovation Llc
FDA Devices Moderate Apr 5, 2017

Regard, Item Number: 880323001, Sterile, LD0754A - C Section - OSU

Resource Optimization & Innovation Llc
FDA Devices Moderate Apr 5, 2017

Regard, Item Number: 800422003, Sterile, OR0491C - Arthroscopy Pk - Spohn

Resource Optimization & Innovation Llc
FDA Devices Moderate Apr 5, 2017

Regard, Item Number: 800036005, Sterile, LD0274E - C Section Pack - FMOL St Francis

Resource Optimization & Innovation Llc
FDA Devices Moderate Apr 5, 2017

Regard, Item Number: 800558004, Sterile, OR0647D - Extremity - Childrens Santa Rosa

Resource Optimization & Innovation Llc
FDA Devices Moderate Apr 5, 2017

The Stryker Visum¿ LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light. Af…

Stryker Communications
FDA Devices Moderate Apr 5, 2017

Regard, Item Number: 800415002, Sterile, OR0484B- Shoulder System Pk - Spohn

Resource Optimization & Innovation Llc
FDA Devices Moderate Apr 5, 2017

Regard, Item Number: 800599001, Sterile, GS0694A - Robotic Lap - Christus Highland

Resource Optimization & Innovation Llc
FDA Devices Moderate Apr 5, 2017

UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical instrument/accessory for use during surgery to implant femoral components …

United Orthopedic Corporation
FDA Devices Moderate Apr 5, 2017

Regard, Item Number: 800553001, Sterile, OR0642A - Total Knee - Medical Center Santa Rosa

Resource Optimization & Innovation Llc

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.