Product category · Updated Jun 3, 2026

Medical Devices recalls

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

Total recalls: 40,478
Top agency: FDA Devices
Years covered: 2000–2026

Reviewed by PlainRecalls Editorial, Product Recalls Editorial Team

Medical Devices accounts for 40,478 recalls — about 40.4% of the federal recall archive, of which 9% of graded records are high-severity.

The FDA, CPSC and NHTSA have published 40,478 medical devices recalls between 2000 and 2026 — roughly 40.4% of the 100,165-record archive. Of the 40,478 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.

40,478 total recalls
40.4% of the archive
9% graded high-severity
FDA Devices top agency

Category snapshot

Medical Devices accounts for 40,478 recalls — about 40.4% of the 100,165-record federal archive, with 3,549 graded high-severity, most issued by FDA Devices.

40,478
total recalls: 9%
graded high-severity: FDA Devices
top issuing agency: 2000–2026
years covered

High severity

3,549
Moderate

35,871
Lower severity

1,058

FDA Devices

39,096
FDA Drug

882
CPSC

441
FDA Food

59

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 58 of 810

FDA Devices Critical Jul 9, 2025

BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg. BiPAP Hybrid A…

Philips Respironics, Inc.

FDA Devices Moderate Jul 9, 2025

Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV START BOX, REF ACC010665

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 9, 2025

interventional fluoroscopic x-ray system

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Jul 9, 2025

My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device

Onkos Surgical, Inc.

FDA Devices Moderate Jul 9, 2025

HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323

Hardy Diagnostics

FDA Devices Moderate Jul 9, 2025

REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence compensation.

Becton, Dickinson and Company, BD Bio Sciences

FDA Devices Moderate Jul 9, 2025

ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but …

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Jul 9, 2025

Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (2) 6900440 Software Version: version 3.2 to vers…

Ortho-Clinical Diagnostics, Inc.

FDA Devices Moderate Jul 9, 2025

Philips L9-3 Transducer.

Philips Ultrasound, Inc

FDA Devices Moderate Jul 9, 2025