Product category · Updated Aug 19, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
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
Severity distribution
Graded records only
- High severity 3,653
High severity
3,653 recalls
- Moderate
Moderate
36,361 recalls
- Lower severity 1,056
Lower severity
1,056 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,794 recalls
- FDA Drug 934
FDA Drug
934 recalls
- CPSC 307
CPSC
307 recalls
- FDA Food 35
FDA Food
35 recalls
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 794 of 822
Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 and 3.1 (version7.0 to version7.5 and version 8.1) and only when or more …
GE Healthcare, LLC
EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation
EEG Info
Medline Total Knee CDS; a single patient prescription procedure pack and disposables, including a back table cover; Product Usage: This Complete …
Medline Industries Inc
Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endoskeleton Implant VBR 2107-0120 20mm Standard Endoskeleton Implant VBR …
TITAN SPINE, LLC
Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Therapy System. Major components of the AR1000 Wound Therapy System incl…
Arobella Medical, LLC
Medrad(R) Continuum MR Infusion System Primary Set Peristaltic Pump System designed for patients who require medications and other fluids during a…
Medrad Inc
Biomet Offset Tibial Tray 2.5 mm Adaptor, REF 141490 Sterile, QTY.1 Product Usage: Knee joint replacement prostheses intended for application wi…
Biomet, Inc.
Persona, The Personalized Knee System, Tibial Broach, Cemented, Size G-H, Nonsterile, This device is used with the Persona Knee System for pat…
Zimmer, Inc.
SpineSix consists of a motorized treatment table that is controlled by an integral computer. The system is operated by means of 12-inch Color LCD tou…
BioMotion Medical Systems, LLC
SOL SYS R 9IN CALC 2.25/15.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire…
DePuy Orthopaedics, Inc.
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE F, LEFT TIBIA SIZE F RIGHT This de…
Zimmer, Inc.
SOL SYS 8IN CALC 1.5/16.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire st…
DePuy Orthopaedics, Inc.
Medrad(R) Continuum MR Infusion System Standard Administration Kit Peristaltic Pump System designed for patients who require medications and other…
Medrad Inc
Persona, The Personalized Knee System, Tibial Drill Guide, Cemented, 15.7 mm Diameter, Nonsterile, Nonsterile This drill guide is used with the …
Zimmer, Inc.
Coonrad/Morrey New Ulnar Revision Kit for Use with Non-Interchangeable Regular Humerals STERILE Rx, Tivanium QTY/PKG:1 Product Usage: The ulnar…
Zimmer, Inc.
Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178
Ebi, Llc
Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size G Left; Size G Right This device is used with the Persona…
Zimmer, Inc.
Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
BioHorizons Implant Systems Inc
The Stryker Model 6390, Power-LOAD, is a power-loading cot fastener system designed to lift, lower, or steer ambulance cots into and out of the ambul…
Stryker Medical Division of Stryker Corporation
SOL SYS 8IN CALC 1.5/15.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire st…
DePuy Orthopaedics, Inc.
Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size E Left; Size E Right This device is used with the Persona…
Zimmer, Inc.
SOL SYS L 9IN CALC 2.25/21 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire s…
DePuy Orthopaedics, Inc.
SOL SYS L 9IN CALC 2.25/18 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire s…
DePuy Orthopaedics, Inc.
Patient Circuit used with the Life Pulse High Frequency Ventilator. The Patient Circuit is a required disposable component of the Life Pulse High Fr…
Bunnell, Inc.
SOL SYS R 9IN CALC 2.25/22.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire…
DePuy Orthopaedics, Inc.
Medrad(R) Continuum MR Infusion System Primary VSA Stopcock Set Peristaltic Pump System designed for patients who require medications and other fl…
Medrad Inc
SOL SYS F 9 CALC L 13.5MM LG Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire…
DePuy Orthopaedics, Inc.
GE Healthcare, Dash 3000/4000/5000. The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthc…
GE Healthcare, LLC
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE G, LEFT TIBIA SIZE G RIGHT This de…
Zimmer, Inc.
SOL SYS L 9IN CALC 2.25/16.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire…
DePuy Orthopaedics, Inc.
SOL SYS 8IN CALCAR SZ12 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem…
DePuy Orthopaedics, Inc.
Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size H Left; Size H Right This device is used with the Persona…
Zimmer, Inc.
Medrad(R) Continuum MR Infusion Pump Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure…
Medrad Inc
Medrad(R) Continuum MR Infusion System Secondary Set Peristaltic Pump System designed for patients who require medications and other fluids during…
Medrad Inc
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile This device is indicated for patients with se…
Zimmer, Inc.
Empi STIMC RE Self Adhesive electrodes. For use on TENS, NMES, FES. a DJO brand A cutaneous electrode is an electrode that is applied directly …
Covidien LLC dba Uni-Patch
DataCare POC is an information management system that provides data management functionality for managing point-of -care testing data.
Roche Molecular Systems, Inc.
Siemens Healthcare ADVIA Centaur Folate (FOL) 500 Test 06891541 100 Test 06367974 Ref Kit (US only) 09132781 Ref Kit (US …
Siemens Healthcare Diagnostics, Inc
DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Intended to be used for mo…
Mindray DS USA, Inc. d.b.a. Mindray North America
The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation of nucleic acids in various types of bi…
Roche Molecular Systems, Inc.
Plum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet Software and a Connectivity Engine peripheral module that provides wired Etherne…
Hospira Inc.
Quasar Power Pack contains a Baby Quasar and a Baby Blue. The Baby Quasar is an infrared LED lamp. The Baby Blue uses blue LED light to be used in co…
Quasar Bio-Tech, Inc. dba Silver Bay LLC
Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase Staining Reagent; an in vitro staining reagent for the qualita…
Leica Microsystems, Inc.
Baby Quasar (LAB-001-D, BQ101) and Baby Quasar Pink (LAB-046-A BQ101-P) are infrared LED lamps that are labeled in part: "***BABY QUASAR***FOR YOUT…
Quasar Bio-Tech, Inc. dba Silver Bay LLC
Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes, A cutaneous electrode is an electrode that is applied directly to a pati…
Covidien LLC dba Uni-Patch
LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well …
Roche Molecular Systems, Inc.
LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid…
Roche Molecular Systems, Inc.
Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Made in the U.S.A. Cutaneous electrode is an electrode that is applied di…
Covidien LLC dba Uni-Patch
SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18. implantable infusion pump. The pump is part of an…
Medtronic Neuromodulation
Siemens Healthcare ADVIA Centaur Digitoxin (DGTN) 250 Test 09046419 50 Test 08861968 Intended Use For in vitro diagnostic …
Siemens Healthcare Diagnostics, 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.
Data sources
- Source: FDA - openFDA Enforcement API (food, drug, and device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls
- Source: NHTSA - National Highway Traffic Safety Administration Recalls (vehicles & equipment)
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.