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Medical device recalls in 2019What 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 2019.

ProductCompanyRecall recordsClass I
SHERPA NX ACTIVEMedtronic, Inc.191191
SYNCHRO 2Stryker Corporation8—
Natrelle Breast ImplantsAllergan, Inc.77
ACCU-CHEK GUIDERoche Diagnostics Operations, Inc.5—
CrossCathCook Incorporated44
VitalityBiomet Spine LLC3—
STRATAFIXEthicon, LLC2—
MOSAICMedtronic, Inc.2—
Electrosurgical Tip Cleaner; PLXodus Medical, Inc.2—
Curlin Administration SetZevex International, Inc.2—
Chlor-XTRAVista Dental2—
CentricityGe Healthcare2—

Companies with the most recall events

CompanyEventsRecordsClass I
GE Healthcare, LLC10256
Edwards Lifesciences, LLC51212
Cook Inc.498
Boston Scientific Corporation323—
Teleflex Medical31717
Maquet Cardiovascular Us Sales, Llc3151
Luminex Corporation39—
Becton Dickinson & Company332
Philips Medical Systems (Cleveland) Inc2145
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)297
Stryker Neurovascular29—
ICU Medical, Inc.288

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
Catheter, Percutaneous DQY192191
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF1896
System, nuclear magnetic resonance imaging LNH64—
Apron, Leaded EAJ24—
Tube, tracheal (w/wo connector) BTR1717
Powered Laser Surgical Instrument GEX14—
Lamp, surgical FTD13—
Catheter, Biliary, Diagnostic FGE13—
Nebulizer (Direct Patient Interface) CAF1313
System, tomography, computed, emission KPS115
System, x-ray, tomography, computed JAK10—
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled FTR1010

Why devices were recalled

FDA root-cause categoryRecordsShare
Device Design25730%
Component design/selection21125%
Unknown/Undetermined by firm8110%
Process control809%
Under Investigation by firm506%
Other304%
Nonconforming Material/Component304%
Software design162%
Incorrect or no expiration date132%
Process design111%
Employee error111%
Vendor change control81%

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

All Class I recalls in 2019 (360)

About this data

Citing this report: “Device Safety Index, Medical Device Recalls in 2019, analysis of FDA recall data,” with a link to this page. Questions or corrections: contact us.