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Medical device recalls in 2025What FDA recall data shows

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.

Most-recalled product lines

Product lines whose models are named by device identifier in recall records posted in 2025.

ProductCompanyRecall recordsClass I
IV Administration SetB. Braun Medical Inc.67—
Allura Xper FDPhilips Medical Systems Nederland B.V.439
EndoWristIntuitive Surgical, Inc.39—
IngeniaPhilips Medical Systems Nederland B.V.27—
BD PyxisCarefusion 303, Inc.27—
VITROSOrtho-Clinical Diagnostics, Inc.21—
AzurionPhilips Medical Systems Nederland B.V.198
A.L.P.S. mvXTyber Medical, LLC18—
AffixusZimmer, Inc.17—
TS 7500Baxter Medical Systems GmbH + Co. KG14—
Sklar InstrumentsSklar Corporation14—
Extension SetB. Braun Medical Inc.131

Companies with the most recall events

CompanyEventsRecordsClass I
MEDLINE INDUSTRIES, LP - Northfield2912615
CareFusion 303, Inc.24416
Baxter Healthcare Corporation226917
Beckman Coulter, Inc.2027—
Philips Medical Systems Nederland B.V.179420
Olympus Corporation of the Americas166027
Boston Scientific Corporation138548
Medline Industries, LP136318
GE Medical Systems, LLC1357—
Beckman Coulter Inc.1215—
Philips North America Llc1065—
Stryker Corporation927—

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
Set, administration, intravascular FPA1144
System, nuclear magnetic resonance imaging LNH11119
Interventional Fluoroscopic X-Ray System OWB8920
System, imaging, pulsed doppler, ultrasonic IYN82—
General surgery tray LRO608
System, x-ray, mobile IZL54—
System, surgical, computer controlled instrument NAY41—
Closed antineoplastic and hazardous drug reconstitution and transfer system ONB39—
System, x-ray, tomography, computed JAK35—
Pump, infusion FRN3421
Stopcock, i.V. Set FMG341
Cabinet, Table And Tray, Anesthesia BRY34—

Why devices were recalled

FDA root-cause categoryRecordsShare
Under Investigation by firm65623%
Process control53419%
Device Design43015%
Software design1676%
No Marketing Application1485%
Nonconforming Material/Component1264%
Process change control1234%
Process design692%
Package design/selection522%
Other452%
Labeling design442%
Labeling Change Control401%

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

All Class I recalls in 2025 (376)

About this data

Citing this report: “Device Safety Index, Medical Device Recalls in 2025, analysis of FDA recall data,” with a link to this page. Questions or corrections: contact us.