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 659 of 819

FDA Devices Moderate Jul 15, 2015

Vaginal Rejuvenation Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

Lipo Pack, Liposuction Expended Pack, and Liposuction Tray - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

Nakoma-SL Anterior Cervical Plating System's Variable Single Barrel Drill Guide Product Usage: The Nakoma-SL ACP System is intended for anterior …

Alliance Partners LLC
FDA Devices Moderate Jul 15, 2015

The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible illumination of the surgical …

Maquet Cardiovascular Us Sales, Llc
FDA Devices Moderate Jul 15, 2015

Standard Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

Vein & Vascular Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

Hand Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

ENT Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Low Jul 15, 2015

PowerPICC SOLO Catheter with Sherlock 3CG (TPS) Stylet 5F Maximal Barrier Tray with Microintroducer The PowerPICC Solo catheters are intended for…

Bard Access Systems
FDA Devices Moderate Jul 15, 2015

Plastic Pack and Plastic HNP Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Low Jul 15, 2015

PowerPICC SOLO2 Catheter 4F Maximal Barrier Tray with Microintroducer (Single-Lumen) (Sherlock) The PowerPICC Solo catheters are intended for sh…

Bard Access Systems
FDA Devices Moderate Jul 15, 2015

Lipo/Buttocks Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

Hand Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

Vein Pack, Vein Treatment II Pack, Vein Brunswick Pack, Vein No Lidocaine Pack, Vein Ablation Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

Face Lift Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

Podiatry Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410. The product is packaged in a thermoformed tray (double sterile ba…

Allergan Inc
FDA Devices Moderate Jul 15, 2015

Face Neck Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

Cysto Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

Upper Extremity Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

Open Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

Advanced Vein Care - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

ComboMap Intravascular Flow and Pressure System; Product/Part number: Combo Map - 802745-001. Intravascular Imaging and Pressure System for e…

Volcano Corp
FDA Devices Moderate Jul 15, 2015

DND Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

Tummy Tuck Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Critical Jul 15, 2015

Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless. Model Numbers: 2.5NEF,3.0NEF,3.5NEF,4.0NEF,4.5NEF,2.5PEF,3.0PEF,3.5PEF,4.…

Covidien LP (formerly Nellcor Puritan Bennett Inc.)
FDA Devices Moderate Jul 15, 2015

Minor Pack and Minor Pack II Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractu…

Synthes, Inc.
FDA Devices Critical Jul 15, 2015

Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended for use in providing tracheal access for airway man…

Covidien LP (formerly Nellcor Puritan Bennett Inc.)
FDA Devices Moderate Jul 15, 2015

Breast Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

Basic Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

Laser Evlt Pack and Laser One Leg Evlt - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

ACL Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

Face Lift Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

Stradi 4500 - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Low Jul 15, 2015

Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp.

Volk Optical Inc
FDA Devices Moderate Jul 15, 2015

Breast Augmentation Pack and Breast Augmentation Expanded Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

Gyn Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System software version 3.6.1. In vitro diagno…

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Jul 15, 2015

Block Versions Used by Dental Offices often referred to as chairside milling: Lava Ultimate Restorative for CEREC, Compatible with Sirona mill 2…

3M Company - Health Care Business
FDA Devices Moderate Jul 15, 2015

Set Up Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

Bariatric Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

Neurosurgery Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

Orthopedic Split Drape Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Low Jul 15, 2015

PowerPICC SOLO Catheter with Sherlock 3CG TPS Stylet 4F Maximal Barrier Tray with Microintroducer The PowerPICC Solo catheters are intended for s…

Bard Access Systems
FDA Devices Moderate Jul 15, 2015

Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile. The DePuy Spine Cable System can be utilized anywhere monofilament…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
FDA Devices Moderate Jul 15, 2015

Eye Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Devices Moderate Jul 15, 2015

Abdominal Pack and Abdom Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.
FDA Drug Moderate Jul 8, 2015

GENTAMICIN 14.4 mg / NS 30 mL SYRINGE, Packaged in 30 mL Syringes, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman …

Lincare, Inc.
FDA Drug Moderate Jul 8, 2015

Diphenhydramine HCl, Diphenhydramine 25mg / NS 10 ml syringe, Qty: 2 10 mL syringes, Rx Only. Compounded by: United Medical IV Center (Little Rock) …

Lincare, 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.