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Medical device recalls in 2024What 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 2024.

ProductCompanyRecall recordsClass I
ADVANTA SLIDER GDSAtrium Medical Corporation51—
ExpoBoston Scientific Corporation4848
IngeniaPhilips Medical Systems Nederland B.V.41—
BD PyxisCarefusion 303, Inc.29—
BivonaIcu Medical, Inc.2828
ScorpioHowmedica Osteonics Corp.26—
InfusomatB. Braun Medical Inc.261
EquinoxeExactech, Inc.26—
MedexIcu Medical, Inc.23—
CODMANIntegra Lifesciences Production Corporation22—
CODMANCerenovus, Inc.22—
VITROSOrtho-Clinical Diagnostics, Inc.19—

Companies with the most recall events

CompanyEventsRecordsClass I
MEDLINE INDUSTRIES, LP - Northfield4443453
Olympus Corporation of the Americas3566—
Baxter Healthcare Corporation329521
Philips North America Llc181203
Beckman Coulter, Inc.1822—
Boston Scientific Corporation1613057
Siemens Healthcare Diagnostics, Inc.1632—
Philips Medical Systems Nederland B.V.1626—
Philips North America15453
Smiths Medical ASD Inc.126143
Ortho-Clinical Diagnostics, Inc.1222—
Randox Laboratories Ltd.1112—

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
Kit, Surgical Instrument, Disposable KDD1809
System, nuclear magnetic resonance imaging LNH127—
Syringe, piston FMF1099
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH78—
General surgery tray LRO773
Orthopedic tray OJH641
Interventional Fluoroscopic X-Ray System OWB58—
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter DSY54—
Catheter, Intravascular, Diagnostic DQO5248
Set, administration, intravascular FPA461
Pump, infusion FRN4315
Cardiovascular procedure kit OEZ421

Why devices were recalled

FDA root-cause categoryRecordsShare
Under Investigation by firm1,01129%
Process control62018%
Nonconforming Material/Component37511%
No Marketing Application2978%
Device Design2948%
Software design1584%
Process design913%
Equipment maintenance872%
Component design/selection832%
Process change control682%
Use error361%
Packaging process control301%

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

All Class I recalls in 2024 (389)

About this data

Citing this report: “Device Safety Index, Medical Device Recalls in 2024, analysis of FDA recall data,” with a link to this page. Questions or corrections: contact us.