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 · 2026-08-27

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 590 of 819

FDA Devices Moderate Aug 24, 2016

Conical 17 degree Angled Abutment Dental implants

Biomet 3i, LLC
FDA Devices Moderate Aug 24, 2016

Prep-Tite Post Dental implants

Biomet 3i, LLC
FDA Devices Moderate Aug 24, 2016

Titanium Hexed Uniscrew Dental implants

Biomet 3i, LLC
FDA Devices Moderate Aug 24, 2016

Certain Flat Implant Cover Screw Dental implants

Biomet 3i, LLC
FDA Devices Moderate Aug 24, 2016

Valleylab Laparoscopic Argon Sharp Needle Electrode 28CM Item Code: E258228 The Valleylab Laparoscopic Handset and Electrodes are indicated for use…

Medtronic
FDA Devices Moderate Aug 24, 2016

Certain Titanium Large Hexed Screw Dental implants

Biomet 3i, LLC
FDA Devices Moderate Aug 24, 2016

EP Healing Abutment Dental implants

Biomet 3i, LLC
FDA Devices Moderate Aug 24, 2016

TRYX Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter d…

TYRX Inc.
FDA Devices Moderate Aug 24, 2016

Certain Gingihue 15 degree Pre- Angled Post Dental implants

Biomet 3i, LLC
FDA Devices Moderate Aug 24, 2016

PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK MicroPort total hip systems intended for use in total hip arthroplasty for reduction or relief of pain and…

MicroPort Orthopedics Inc.
FDA Devices Moderate Aug 24, 2016

Valleylab Laparoscopic Straight Spatula Electrode 36C Item Code: E277036 The Valleylab Laparoscopic Handset and Electrodes are indicated for use i…

Medtronic
FDA Devices Moderate Aug 24, 2016

Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US. Designed to replace the native or surgical bioprost…

Medtronic Cardiovascular Surgery-the Heart Valve Division
FDA Devices Moderate Aug 24, 2016

TRYX Neuro Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardiove…

TYRX Inc.
FDA Devices Moderate Aug 24, 2016

Locator Abutment Dental implants

Biomet 3i, LLC
FDA Devices Moderate Aug 24, 2016

Certain Straight Pick Up Coping Dental implants

Biomet 3i, LLC
FDA Devices Moderate Aug 24, 2016

Certain EP Healing Abutment Dental implants

Biomet 3i, LLC
FDA Devices Moderate Aug 24, 2016

Certain Non-Hexed Implant Pick-up Coping Dental implants

Biomet 3i, LLC
FDA Devices Moderate Aug 24, 2016

IOL Titanium Temporary Cylinder Dental implants

Biomet 3i, LLC
FDA Devices Moderate Aug 24, 2016

Stryker AutoPlex System. Model Numbers 0607-687-000, 0605-887-000, 0605-687-000, and 0605-683-000. For bone cement. Stryker AutoPlex System ki…

Stryker Instruments Div. of Stryker Corporation
FDA Devices Moderate Aug 24, 2016

O-Ring Abutment 4.1mm(D) x 4mm(H) Item: OSO40 Dental implants

Biomet 3i, LLC
FDA Devices Moderate Aug 24, 2016

Locator Extended Range Males 4pk Dental implants

Biomet 3i, LLC
FDA Devices Moderate Aug 24, 2016

O-Ring Abutment 4.1mm(D) x 2mm(H) Item: OSO20 Dental implants

Biomet 3i, LLC
FDA Devices Moderate Aug 24, 2016

Conical Abutment Pick-up Coping Dental implants

Biomet 3i, LLC
FDA Devices Moderate Aug 24, 2016

Standard Abutment Dental implants

Biomet 3i, LLC
FDA Devices Moderate Aug 24, 2016

Valleylab Laparoscopic AP Argon Blunt Needle Electrode 28cm Item Code: E258328 The Valleylab Laparoscopic Handset and Electrodes are indicated for …

Medtronic
FDA Devices Moderate Aug 24, 2016

Certain Gingihue 15 degree Angled Post 4.1mm(D) x 5mm(P) x 4mm(H) Item: IPAP454G. Dental implants

Biomet 3i, LLC
FDA Devices Moderate Aug 24, 2016

LDA Screw SBL 4mm(D) Item: SCRSBL2 Dental implants

Biomet 3i, LLC
FDA Devices Moderate Aug 24, 2016

Certain Temporary Non-Hexed Cylinder Dental implants

Biomet 3i, LLC
FDA Devices Moderate Aug 24, 2016

Preformance 15 degrees pre-angled post Dental implants

Biomet 3i, LLC
FDA Devices Moderate Aug 24, 2016

Standard Abutment Transfer Coping Dental implants

Biomet 3i, LLC
FDA Devices Moderate Aug 24, 2016

Standard Abutment Temporary Screw Dental implants

Biomet 3i, LLC
FDA Devices Moderate Aug 24, 2016

Certain Pick-Up Coping 5mm(D) x 5mm(P) Item:IWIP55 Dental implants

Biomet 3i, LLC
FDA Devices Moderate Aug 24, 2016

Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 2mm(H) Item: IWTH52 Dental implants

Biomet 3i, LLC
FDA Devices Moderate Aug 24, 2016

Gold-Tite Hexed Retaining Screw 3mm Item: GSH30 Dental implants

Biomet 3i, LLC
FDA Devices Moderate Aug 24, 2016

Certain Locator Abutment Dental implants

Biomet 3i, LLC
FDA Devices Moderate Aug 24, 2016

Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a medical image and information management system that allows viewing, se…

Merge Healthcare, Inc.
FDA Devices Moderate Aug 24, 2016

TI Single Vector Distractor Body with Right Foot/30mm; Catalog ID 487.964 The Titanium Single Vector Distractor and Proximal Foot Plates are inten…

Synthes (USA) Products LLC
FDA Devices Moderate Aug 24, 2016

Index Coping Surgical Dental implants

Biomet 3i, LLC
FDA Devices Moderate Aug 24, 2016

Certain Twist Lock TM Straight Transfer Coping Dental implants

Biomet 3i, LLC
FDA Devices Moderate Aug 24, 2016

Certain Implant Cover Screw Dental implants

Biomet 3i, LLC
FDA Devices Moderate Aug 24, 2016

ReShape Integrated Dual Balloon System, Gen 1, Catalog No. RSM110, Model No. 01-0013-001 The ReShape Integrated Dual Balloon System is indicated f…

Reshape Medical Inc
FDA Devices Moderate Aug 24, 2016

Conical Healing Cap Dental implants

Biomet 3i, LLC
FDA Devices Moderate Aug 24, 2016

Certain Implant Straight Cover Screw Dental implants

Biomet 3i, LLC
FDA Devices Moderate Aug 24, 2016

Locator Abutment Impression Coping Dental implants

Biomet 3i, LLC
FDA Devices Moderate Aug 24, 2016

1.5 mm HYDRO LeMaitre Valvulotome, 40 cm. Sterile REF # 1010-00 Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of v…

LeMaitre Vascular, Inc.
FDA Devices Moderate Aug 24, 2016

Certain EP Twist Lock TM Coping Dental implants

Biomet 3i, LLC
FDA Devices Moderate Aug 24, 2016

AB SCIEX Triple Quad 4500MD LC/MS/MS System. Mass Spectrometer for In-Vitro Diagnostic Use. Instrument Part Number (REF): 5031257 3200MD series a…

Ab Sciex
FDA Devices Moderate Aug 24, 2016

Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 6" Item Code: E25306 The Valleylab Laparoscopic Handset and Electrodes are indicated …

Medtronic
FDA Devices Moderate Aug 24, 2016

Locator Replacement Housing Dental implants

Biomet 3i, LLC
FDA Devices Moderate Aug 24, 2016

Bard TruGuide Disposable Coaxial Biopsy Needle  Mixed Product Part Number C1816B The TruGuide Disposable Coaxial Biopsy Needles are intended for…

Bard Peripheral Vascular 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.