Product category · Updated Jul 29, 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 (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
Severity distribution
Graded records only
- High severity 3,645
High severity
3,645 recalls
- Moderate
Moderate
36,211 recalls
- Lower severity 1,054
Lower severity
1,054 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,635 recalls
- FDA Drug 934
FDA Drug
934 recalls
- CPSC 306
CPSC
306 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 580 of 819
OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance Product Usage: The OEC Brivo Mobile C-Arm X-Ray Products are designed to prov…
GE OEC Medical Systems, Inc
Teleflex Percuaneous Solutions, Gripper Grasper, Ref ML003EE, Rx Only Sterile Manufactured for: Teleflex Medical, Park, NC 27709 The Percutaneous …
Teleflex Medical
Radiation Therapy Treatment Planning System, Model 5.0
RAYSEARCH LABORATORIES AB
Phoenix Recon Soft Tissue Sleeve Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical Instruments for the Arm Product Usage:…
Zimmer Biomet, Inc.
CONCEPT HEATWAVE Electrode 130 mm x 2.3 mm diameter, REF/Catalog Number CS-023, STERILE, Rx Only Product Usage: The HeatWave Electrode is intended…
ConMed Corporation
Teleflex Percuaneous Solutions, Johans Grasper, Ref ML004EE, Rx Only Sterile Manufactured for: Teleflex Medical, Park, NC 27709 The Percutaneous S…
Teleflex Medical
BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgica…
Surgical Specialties Mexico S DE RL DE CV
TransMotion Medical, TMM5 Series Mobile Surgical Stretcher -Chair. Intended use is to provide the caregiver a single platform for receiving, trans…
Winco Mfg., LLC
Blood Pressure Monitor UA-767PBT-Ci for small cuff. Designed to be used by end users who are eighteen (18) years and older at home to monitor their …
A & D Enginering Inc
Varithena (polidocanol injectable foam) Administration Pack For Use With Varithena, Rx only, Distributed by Biocompatibles, Inc. Oxford, CT 06478, ND…
Biocompatibles U.K., Ltd.
Zenostar MT Color A2 60ml, art. no. 681051. Product Usage: For coloring dental porcelain
Ivoclar Vivadent, Inc.
Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain
Ivoclar Vivadent, Inc.
Operating Table TruSystem 7000 U, Material Number 1604788; Operating Table TruSystgem 7000 U (MB), Material Number 1604786 Patient positioning durin…
Trumpf Medical Systems, Inc.
Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For coloring dental porcelain
Ivoclar Vivadent, Inc.
Mobile Column TruSystem 7500, Material Number 1717023; Mobile Column TruSystem 5500, Material Number 1607822 Patient positioning during surgery, ran…
Trumpf Medical Systems, Inc.
Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by compu…
Philips Medical Systems
Zenostar MT Color D3 60ml, art. no. 681064. Product Usage: For coloring dental porcelain
Ivoclar Vivadent, Inc.
Multix Fusion Stationary X-Ray System Product Usage: The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical pr…
Siemens Medical Solutions USA, Inc
ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue; for us…
New Star Lasers, Inc.
Floor Mounting Column TS 7500 U, Material Number 1730732; Floor Mounting Column ARTIS, Material Number 1501878 Patient positioning during surgery, …
Trumpf Medical Systems, Inc.
Zenostar MT Color C2 60ml art. no. 681060. Product Usage: For coloring dental porcelain
Ivoclar Vivadent, Inc.
Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary packaged in to…
Integra LifeSciences Corp.
Toshiba America Medical Systems, Inc . Aquilion RXL TSX-101 A/R, U CT Scanner Diagnostic imaging systems indicated to acquire and display cross …
Toshiba American Medical Systems Inc
Arthrex Suture Washer
Arthrex, Inc.
Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in a PVC tray, then secondary package in to Tyvek pouch and ter…
Integra LifeSciences Corp.
CT3Plus (a.k.a. CT3PZ); Catalog number: 7300-0038/ 7300-0038-1. Dermatology: For use in dermatology for incision, excision, ablation, and vapor…
New Star Lasers, Inc.
Merit Inflation Syringe Kit. Catalog Number KOS-02857
Merit Medical Systems, Inc.
Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is intended for use in removing arterial emboli.
Arrow International Inc
Zenostar MT Color A3.5 60ml, art. no. 681053. Product Usage: For coloring dental porcelain
Ivoclar Vivadent, Inc.
Stationary Column TruSystem 7599, Material Number 1717020 Patient positioning during surgery, ranging from anesthesia induction to actual surgery …
Trumpf Medical Systems, Inc.
Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by compu…
Philips Medical Systems
Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray images. The P…
Panoramic Rental Corp.
0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standa…
Baxter Corporation Englewood
ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cag…
LDR Spine USA, Inc.
Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain
Ivoclar Vivadent, Inc.
Zenostar MT Color D4 60ml, art. no. 681065. Product Usage: For coloring dental porcelain
Ivoclar Vivadent, Inc.
MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath used to facilitate placing a catheter through the skin into …
Argon Medical Devices, Inc
Dimension Vista¿ Calcium (CA) Flex¿ reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB
Siemens Healthcare Diagnostics, Inc.
Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Ivoclar Vivadent, Inc.
Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner.
Toshiba American Medical Systems Inc
Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Ivoclar Vivadent, Inc.
Zenostar MT Color B3 60ml, art. no. 681057. Product Usage: For coloring dental porcelain
Ivoclar Vivadent, Inc.
Vanguard 360 Revision Knee System Knee prostheses
Zimmer Biomet, Inc.
Zenostar MT Color A4 60ml, art. no. 681054. Product Usage: For coloring dental porcelain
Ivoclar Vivadent, Inc.
Thermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribution); 0373852 (Foreign Distribution) Product Usage: The QMS Everoli…
Microgenics Corporation
TriFoillmaging Triumph/Triumph II Research CT scanners.
Northridge Tri-Modality Imaging,
Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Ivoclar Vivadent, Inc.
Integra Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in one Tyvek pouch. Five (5) sealed Tyvek pouches are packaged in a cardbo…
Integra LifeSciences Corp.
Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner
Toshiba American Medical Systems Inc
Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner
Toshiba American Medical Systems 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 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.