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Medical device recalls in 2026What FDA recall data shows, January–October 2026

Updated Oct 18, 2026 · FDA recall data dated Oct 16, 2026

Key findings

Recall records by month

Red = Class I. Click a month for every recall posted that month. Recent months grow as the FDA classifies and posts more records.

Most-recalled product lines

Product lines whose models are named by device identifier in recall records posted in January–October 2026.

ProductCompanyRecall recordsClass I
IngeniaPhilips Medical Systems Nederland B.V.44—
ARROWTeleflex Incorporated4234
AzurionPhilips Medical Systems Nederland B.V.35—
Allura Xper FDPhilips Medical Systems Nederland B.V.27—
Impella Heart PumpAbiomed, Inc.2119
Soft-VuAngiodynamics, Inc.16—
NAMICMedline Industries, Inc.1412
CONNECTING TUBEOlympus Medical Systems Corp.12—
ATTUNEDepuy (Ireland)11—
AIRSEALConmed Corporation11—
Single Use 3-Lumen Sphincterotome VOlympus Medical Systems Corp.10—
Centurion Medical Products CorpMedline Industries, Inc.10—

Companies with the most recall events

CompanyEventsRecordsClass I
Medline Industries, LP5549269
Olympus Corporation of the Americas231193
Boston Scientific Corporation204911
Philips Medical Systems Nederland B.V.1874—
AVID Medical, Inc.165822
Abiomed, Inc.123129
Baxter Healthcare Corporation12186
Intuitive Surgical, Inc.12161
Siemens Healthcare Diagnostics, Inc.1011—
Philips North America Llc928—
ICU Medical, Inc.820—
Siemens Medical Solutions USA, Inc815—

Companies that assemble kits or reprocess devices often appear high: when a component is recalled, every kit that contains it gets its own record.

Most-recalled device types

Device type (FDA product code)RecordsClass I
Interventional Fluoroscopic X-Ray System OWB96—
General surgery tray LRO8820
Tourniquet, Pneumatic KCY69—
System, nuclear magnetic resonance imaging LNH59—
Cardiovascular procedure kit OEZ4510
Unit, electrosurgical, endoscopic (with or without accessories) KNS436
System, x-ray, tomography, computed JAK36—
Orthopedic tray OJH326
Catheter, Recording, Electrode, Reprocessed NLH325
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph CHL32—
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX31—
Cardiac catheterization kit OES3012

Why devices were recalled

FDA root-cause categoryRecordsShare
Under Investigation by firm69428%
Process control35114%
Nonconforming Material/Component33214%
Device Design2199%
Software design1576%
Process change control1376%
No Marketing Application823%
Material/Component Contamination592%
Component design/selection532%
Labeling Change Control372%
Process design301%
Component change control281%

“Under Investigation by firm” means the company had not yet reported a root cause when the record was posted.

All Class I recalls in January–October 2026 (287)

About this data

Citing this report: “Device Safety Index, Medical Device Recalls in 2026, analysis of FDA recall data,” with a link to this page. Questions or corrections: contact us.