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Medical device recalls in 2023What 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 2023.

ProductCompanyRecall recordsClass I
RUSCHTeleflex Incorporated124122
Unicondylar Sled ProsthesisWALDEMAR LINK GmbH & Co. KG48—
MAHURKARMozarc Medical US LLC2525
Spetzler-MalisStryker Corporation19—
JACKSON-PRATTCardinal Health 200, LLC19—
Compress DeviceBiomet Orthopedics, LLC19—
TitanColoplast A/S17—
VITROSOrtho-Clinical Diagnostics, Inc.16—
Guider Softip XFBoston Scientific Corporation15—
GRAFTONand GRAFTON PLUSDemineralized Bone Matrix (DBM)Medtronic Sofamor Danek, Inc.14—
ProCuityStryker Corporation13—
LINK InstrumentWALDEMAR LINK GmbH & Co. KG12—

Companies with the most recall events

CompanyEventsRecordsClass I
MEDLINE INDUSTRIES, LP - Northfield232104
Olympus Corporation of the Americas226814
Datascope Corp.163918
Siemens Medical Solutions USA, Inc1627—
Baxter Healthcare Corporation16217
Philips North America Llc14351
Siemens Healthcare Diagnostics, Inc.1125—
Ortho-Clinical Diagnostics, Inc.1118—
Medtronic Neuromodulation1015—
Encore Medical, LP915—
Beckman Coulter, Inc.912—
Stryker Corporation839—

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
Tube, tracheal (w/wo connector) BTR127123
Implantable cardioverter defibrillator (non-CRT) LWS6460
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) NIK6160
Accelerator, Linear, Medical IYE50—
Interventional Fluoroscopic X-Ray System OWB40—
General surgery tray LRO391
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX39—
Electrosurgical, Cutting & Coagulation & Accessories GEI3912
Bronchoscope (flexible or rigid) EOQ3911
System, Balloon, Intra-Aortic And Control DSP3818
System, x-ray, tomography, computed JAK37—
Ventilator, Continuous, Facility Use CBK3429

Why devices were recalled

FDA root-cause categoryRecordsShare
Under Investigation by firm86236%
Process control32013%
Device Design29712%
Nonconforming Material/Component1396%
Storage1044%
Software design843%
Labeling design663%
Other623%
Process change control572%
Labeling Change Control562%
Employee error472%
Unknown/Undetermined by firm412%

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

All Class I recalls in 2023 (502)

About this data

Citing this report: “Device Safety Index, Medical Device Recalls in 2023, analysis of FDA recall data,” with a link to this page. Questions or corrections: contact us.