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 · 2026-08-21

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 444 of 819

FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail Left 130 11 mm x 380 mm, Item Number 814611380 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.
FDA Devices Moderate Oct 24, 2018

Gibco Sodium Pyruvate (100 mM) SKU 11360070, for In-Vitro Diagnostic Use

Life Technologies, Corp.
FDA Devices Moderate Oct 24, 2018

Reinforced Dual Lumen Cannula, 19Fr., REF: VV19F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a sing…

OriGen Biomedical, Inc.
FDA Devices Moderate Oct 24, 2018

ADVIA Centaur CKMB Master Curve Material, Cat No. 07867768 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB ass…

Siemens Healthcare Diagnostics, Inc
FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail - Left 125 11mm x 340mm, Item Number 814411340 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.
FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail Right 125 13 mm x 260 mm, Item Number 814313260 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.
FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail Left 125 11 mm x 260 mm, Item Number 814411260 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.
FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail Right 125 9 mm x 340 mm, Item Number 814309340 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.
FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail Left 125 9 mm x 300 mm, Item Number 814409300 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.
FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail Left 130 15 mm x 360 mm, Item Number 814615360 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.
FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail Right 125 11 mm x 420 mm, Item Number 814311420 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.
FDA Devices Moderate Oct 24, 2018

Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage: The HeartStart FR3 is used to treat suspected victims of ventricular f…

Philips Electronics North America Corp.
FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail Right 125 9 mm x 440 mm, Item Number 814309440 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.
FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail Left 125 9 mm x 260 mm, Item Number 814409260 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.
FDA Devices Moderate Oct 24, 2018

Biograph Horizon a) 3R, Material Number 10532746 b) 4R, Material Number 10532748 The Siemens Biograph Horizon and Biograph mCT systems are combi…

Siemens Medical Solutions USA, Inc.
FDA Devices Moderate Oct 24, 2018

"Free and Total Protein S ELISA Kit" Cat. No. 5292 For use in the quantitation of free and total Protein antigen in citrated human plasma Contains: 9…

Helena Laboratories, Inc.
FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail Right 130 11 mm x 360 mm, Item Number 814511360 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.
FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail Right 125 9 mm x 300 mm, Item Number 814309300 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.
FDA Devices Moderate Oct 24, 2018

AS-OBGYN Information System version 7.824.x

AS Software, Inc.
FDA Devices Moderate Oct 24, 2018

GE Healthcare MRI Systems, Software Version 15.x or HD 16 sold under the following product names: *ER*15T HDXT ECHOSPEED 16 CHANNEL, *OC*1.5T HD…

GE Medical Systems, LLC
FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail Left 130 9 mm x 360 mm, Item Number 814609360 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.
FDA Devices Moderate Oct 24, 2018

ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB…

Siemens Healthcare Diagnostics, Inc
FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail Right 125 13 mm x 300 mm, Item Number 814313300 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.
FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail 125 9 mm x 165 mm, Item Number 816709165 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.
FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail Left 125 9 mm x 320 mm, Item Number 814409320 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.
FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail Right 125 13 mm x 360 mm, Item Number 814313360 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.
CPSC No agency class Oct 18, 2018

Kikkerland Recalls Wireless Charger Bedside Pockets Due to Fire and Burn Hazard

Ningbo Hongrui Imp. & Exp. CP. Ltd., of China
FDA Devices Moderate Oct 17, 2018

Colpo-Pneumo Occluder, Part CPO-6

CooperSurgical, Inc.
FDA Devices Moderate Oct 17, 2018

OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSNCREF311-L.

Orthosensor, Inc.
FDA Devices Moderate Oct 17, 2018

OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Right, REF ZBH-PSNCRGH712-R.

Orthosensor, Inc.
FDA Devices Moderate Oct 17, 2018

Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a) small curl (16.8mm curve …

Sterilmed, Inc.
FDA Devices Moderate Oct 17, 2018

Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10 Intended use: BABY440 is intended for, but not limited to, …

Widex A/S
FDA Devices Moderate Oct 17, 2018

OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, REF ZBH-PSNCREF311-R.

Orthosensor, Inc.
FDA Devices Moderate Oct 17, 2018

Unna-Z: Unna Boot Compression Wrap with Zinc Oxide and Calamine, Item Numbers: a) NONUNNA3 and b) NONUNNA4 Product is packaged in a foil pouch, w…

MEDLINE INDUSTRIES INC
FDA Devices Moderate Oct 17, 2018

AVS Aria Cage, Catalog Number 48753212 Product Usage: The Stryker Spine AVS¿ ARIA 1M PEEK Spacers are intervertebral body fusion devices indicate…

Stryker Spine
FDA Devices Moderate Oct 17, 2018

GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARESCAPE B450 in 510(k) countries [UR_CRSCP-885]: The CARESCAPE Monitor B45…

GE Healthcare Finland Oy
FDA Devices Moderate Oct 17, 2018

NeoMed Enteral Feeding Tubes with Enteral Only Connectors, French sizes 4.0Fr, 5.0Fr, 6.5Fr, 8.0Fr, and lengths 40cm, 60cm, 90cm. The product consis…

Neomed Inc
FDA Devices Moderate Oct 17, 2018

Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to hel…

Reckitt Benckiser LLC
FDA Devices Moderate Oct 17, 2018

OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, REF ZBH-PSNCRCD39-R.

Orthosensor, Inc.
FDA Devices Moderate Oct 17, 2018

Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administration Sets (PAS) and Intego PET Infusion Systems Product Usage: 1.2 …

Bayer Medical Care, Inc.
FDA Devices Moderate Oct 17, 2018

Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL¿ ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, …

Instrumentation Laboratory Co.
FDA Devices Moderate Oct 17, 2018

GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of CARESCAPE B850 V2 in 510(k) countries [UR_CRSCP-1046]: The CARESCAPE Monit…

GE Healthcare Finland Oy
FDA Devices Moderate Oct 17, 2018

BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED PG UPN: H965440210 Catalog Number: 44-021 Box…

Angiodynamics Inc. (Navilyst Medical Inc.)
FDA Devices Moderate Oct 17, 2018

Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions…

Implant Direct Sybron Manufacturing, LLC
FDA Devices Moderate Oct 17, 2018

Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as a departmental Picture Archiving and C…

Agfa Healthcare NV
FDA Devices Moderate Oct 17, 2018

VITROS 5600 Integrated System- (Refurbished). For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of a…

Ortho-Clinical Diagnostics
FDA Devices Moderate Oct 17, 2018

VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinic…

Ortho-Clinical Diagnostics
FDA Devices Moderate Oct 17, 2018

INSORB SUBCUTICULAR SKIN STAPLER, REF 2030

Incisive Surgical Inc
FDA Devices Moderate Oct 17, 2018

OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, REF ZBH-PSNCRCD39-L.

Orthosensor, Inc.
FDA Devices Low Oct 17, 2018

BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint G…

Becton Dickinson & Co.

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.