PlainRecalls

Product category · Updated Aug 19, 2026

Medical Devices recalls

Medical device recalls including implants, diagnostic equipment, and surgical tools

Total recalls
41,070
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 (41,070 notices, 39.3% of the archive); 9% of graded records are high-severity.

The FDA, CPSC, USDA FSIS and NHTSA have published 41,070 medical devices recalls between 2000 and 2026 - roughly 39.3% of the 104,423-record archive. Among 12 product categories, that is #1 of 12. Of the 41,070 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.

  • 41,070 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 41,070 recalls, about 39.3% of the 104,423-record federal archive, with 3,653 graded high-severity, most issued by FDA Devices.

41,070
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

41,070 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 · USDA FSIS · NHTSA federal recall filings · 2026-09-03

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 1947

Source: FDA · CPSC · USDA FSIS · NHTSA As of Aug 19, 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 790 of 822

FDA Devices Moderate Feb 6, 2013

TUNNELOC ROUND HEAD INTERFERENCE SCREW 8MMX25MM Biomet Sports Medicine manufactures a variety of internal fixation devices intended to aid in arthr…

Biomet, Inc.
FDA Devices Moderate Feb 6, 2013

COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE.

Roche Molecular Systems, Inc.
FDA Devices Moderate Feb 6, 2013

Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachyther…

Varian Medical Systems, Inc.
FDA Devices Moderate Feb 6, 2013

45¿ Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY 14031. Model #: P2661, P2662, T3635, T5586,T6031, T6164,T10161, T12…

Greatbatch Medical
FDA Devices Moderate Feb 6, 2013

Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX, part of the Esteem Totally Implantable Hearing System. The ISA and Commander …

Envoy Medical Corporation
FDA Devices Moderate Feb 6, 2013

BBL(TM) Fildes Enrichment, catalog number 211866, 10 tubes/pack, labeled in part ***Becton Dickinson and Company, Sparks, MD 21152 USA*** Intended…

Becton Dickinson & Co.
FDA Devices Moderate Feb 6, 2013

Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4 Henderson Drive West Caldwell, NJ 07006 Al…

Alfa Wassermann, Inc.
FDA Devices Moderate Feb 6, 2013

Ethicon Endo-Surgery Inc. The ENSEAL¿ G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopi…

Ethicon Endo-Surgery Inc
FDA Devices Moderate Feb 6, 2013

Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920 Product Usage: Universal R/F, general use

Philips Healthcare Inc.
FDA Devices Moderate Feb 6, 2013

Cordis, a Johnson and Johnson Company, ExoSeal(TM) 6F Vascular Closure Device, cat. No EX500, EX600, and EX700. Used for femoral artery puncture …

Cordis Corporation
FDA Devices Moderate Feb 6, 2013

Motorola Solutions PCS3000/CS3070 Laser Utility/Peripheral Laser Products

Motorola Inc
FDA Devices Moderate Feb 6, 2013

BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Sterile; IVD; REF 363083; 13 X 75 mm, 2.7 mL

Becton Dickinson & Company
FDA Devices Low Feb 6, 2013

Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010. The Dimension(R) IRON Calibrator is an in vitro diagnostic product intended…

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Feb 6, 2013

Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 101165…

Abbott Vascular
FDA Devices Low Feb 6, 2013

Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769 Alere Cholestech LDX Multianalyte Control (hereafter referred to as C…

Alere San Diego, Inc.
FDA Devices Moderate Feb 6, 2013

BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is intended to be recover and detect aerobic microorganisms (bacteria and fun…

bioMerieux, Inc.
FDA Devices Moderate Feb 6, 2013

AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6.

GE Healthcare, LLC
FDA Devices Moderate Feb 6, 2013

Extremity Medical, IO FiX System Accessory. Catalog Number 101-00010. This screw measuring device is an accessory to the IO FiX Screw and Washe…

Extremity Medical LLC
FDA Devices Moderate Feb 6, 2013

Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities.

Mindray DS USA, Inc. d.b.a. Mindray North America
FDA Devices Critical Feb 6, 2013

HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Ventilator is intended to provide positive pressure ventilatory …

Hamilton Medical Inc
FDA Devices Moderate Jan 30, 2013

UltraClean(R) Accessory Electrode 6 inch Coated Needle with Extended Insulation, REF/Catalog No. 139108, Single Use, Sterile, Rx ONLY -- CONMED CORPO…

ConMed Corporation
FDA Devices Moderate Jan 30, 2013

Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog number 441916, clinical diagnostic instrument.

Becton Dickinson & Co.
FDA Devices Moderate Jan 30, 2013

UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulation, REF/Catalog No. 139110EXT, Single Use, Sterile, Rx ONLY -- CONMED CO…

ConMed Corporation
FDA Devices Moderate Jan 30, 2013

UltraClean(R) Accessory Electrode 4 inch Coated Blade, REF/Catalog No. 139112, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, C…

ConMed Corporation
FDA Devices Moderate Jan 30, 2013

UltraClean(R) Accessory Electrode 1 inch Coated Needle, REF/Catalog No. 139102, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, …

ConMed Corporation
FDA Devices Moderate Jan 30, 2013

Goldvac(TM) UltraClean(R) Accessory Electrode 4 inch Coated Blade, REF/Catalog No. 60-7524-001, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgica…

ConMed Corporation
FDA Devices Moderate Jan 30, 2013

UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended Insulation, REF/Catalog No. 139104EXT, Single Use, Sterile, Rx ONLY -- CONMED CO…

ConMed Corporation
FDA Devices Moderate Jan 30, 2013

Lifestyles Pleasure Collection 30 Premium Lubricated Condoms Assortment of Ultra Sensitive, Flavors and Colors, Skyn, Thryll, Thyn, and Ultra Thin…

Ansell Healthcare Products LLC
FDA Devices Moderate Jan 30, 2013

DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl Product Code: 1867-15-880 Spinal Implant Component.

DePuy Spine, Inc.
FDA Devices Moderate Jan 30, 2013

DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 Spinal Implant Component.

DePuy Spine, Inc.
FDA Devices Moderate Jan 30, 2013

Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulation, REF/Catalog No. 60-7523-001, Sterile, Rx ONLY -- CONMED C…

ConMed Corporation
FDA Devices Moderate Jan 30, 2013

Medisystems 17 Gauge x 1" inch AV Fistula Needle Product Code: D9-2007MGLB Product Usage: Medisystems AVF with MasterGuard anti-stick needle pro…

Medisystems a NX Stage Company
FDA Devices Moderate Jan 30, 2013

Goldvac(TM) UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended Insulation, REF/Catalog No. 60-7521-001, Sterile, Rx ONLY -- CONMED C…

ConMed Corporation
FDA Devices Moderate Jan 30, 2013

UltraClean(R) Accessory Electrode 4 inch Coated Blade with Extended Insulation, REF/Catalog No. 139112EXT, Single Use, Sterile, Rx ONLY -- CONMED CO…

ConMed Corporation
FDA Devices Moderate Jan 30, 2013

ELECTROSURGICAL ENT NEEDLE ELECTRODE, 6 inch with Extended Insulation, REF/Catalog No. 138025, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Ele…

ConMed Corporation
FDA Devices Moderate Jan 30, 2013

ABC(R) NOZZLE, Single Patient Use Nozzle, (For use with 130500 Reusable ABC(R) Handpiece), REF/Catalog No. 130343, Sterile, Rx ONLY -- CONMED CORPORA…

ConMed Corporation
FDA Devices Moderate Jan 30, 2013

Abbott Laboratories, ARCHITECT 25-OH Vitamin D Reagent Kit, 03L52-25 (ROW) and 03L52-27 (U.S.) (1 x 100 tests), 03L52-35 (ROW) and 03L52-37 (U.S.) (5…

Abbott Laboratories
FDA Devices Moderate Jan 30, 2013

Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product Usage: Medisystems Buttonhole Needle Sets are indicated fo…

Medisystems a NX Stage Company
FDA Devices Moderate Jan 30, 2013

DePuy Spine VIPER POLY SCREW 5.5 8 X100MM Tl Product Code: 1867-15-899 Spinal Implant Component.

DePuy Spine, Inc.
FDA Devices Moderate Jan 30, 2013

DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl Product Code: 1867-15-870 Spinal Implant Component.

DePuy Spine, Inc.
FDA Devices Moderate Jan 30, 2013

ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, Disposable Hyfrecator(R) Tips, REF/Catalog No. 7-101-8CS, Sterile, Rx ONLY -- CONMED CORPORATION Ele…

ConMed Corporation
FDA Devices Moderate Jan 30, 2013

UltraClean(R) Accessory Electrode, 1 inch Coated Blade, REF/Catalog No. 139100, Single Use, Sterile, Rx ONLY --CONMED CORPORATION, Electrosurgical, …

ConMed Corporation
FDA Devices Moderate Jan 30, 2013

DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 Spinal Implant Component.

DePuy Spine, Inc.
FDA Devices Moderate Jan 30, 2013

DePuy Spine VIPER POLY SCREW 5.5 9 X 80MM Tl Product Code: 1867-15-980 Spinal Implant Component.

DePuy Spine, Inc.
FDA Devices Moderate Jan 30, 2013

GreenLight HPS (High Performance System) GreenLight XPS (Xcelerated Performance System) Manufactured by AMS, Solutions for Life Innovation Cente…

AMS Innovative Center - San Jose
FDA Devices Moderate Jan 30, 2013

Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I (cTnI) test is an in vitro diagnostic test for the quantitive measuremen…

Abbott Point of Care Canada Limited
FDA Devices Moderate Jan 30, 2013

UltraClean(R) Accessory Electrode 1 inch Coated Needle with Extended Insulation, REF/Catalog No. 139105EXT, Single Use, Sterile, Rx ONLY -- CONMED CO…

ConMed Corporation
FDA Devices Moderate Jan 30, 2013

Electrosurgical Tip Cleaner, REF/Catalog No. 138029, Single Use, Sterile, Rx ONLY -- Distributed By: CONMED CORPORATION Electrosurgical, Cutting and…

ConMed Corporation
FDA Devices Moderate Jan 30, 2013

Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade, REF/Catalog No. 60-7526-001, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgic…

ConMed Corporation
FDA Devices Low Jan 30, 2013

Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.

Roche Diagnostics Operations, 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

25,513 recalls →

Drugs & Medications

14,473 recalls →

Vehicles

8,938 recalls →

Children & Baby Products

4,017 recalls →

Household Products

3,574 recalls →

Dietary Supplements

2,018 recalls →

Data sources

Category data as of Aug 19, 2026.

Every figure on PlainRecalls is rendered directly from official FDA, CPSC, USDA FSIS 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 Aug 19, 2026.