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Inspire Medical Systems Inc.

Inspire Medical Systems Inc. Recalls

All product recalls associated with Inspire Medical Systems Inc..

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Recall Summary

Total Recalls

1000

Past Year

353

Class I (Serious)

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 501–520 of 3680 recalls

Inspire Model 4063 Stimulation Lead (Inspire) – Labeling Error (2024)

Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.

Low

FDAJul 31, 2024Nationwide• Inspire Medical Systems Inc.

Inspire Model 4340 Respiratory Sensing Lead (Inspire) – Labeling Error (2024)

Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.

Low

FDAJul 31, 2024Nationwide• Inspire Medical Systems Inc.

VariSoft Infusion Set, Single Use. (Unomedical A/S Osted Aholmvej 1) – specific varisofttm infusion sets wer... (2024)

Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set".

Low

FDA

1...24 252627 28...184

Page 26 of 184Next

Jul 23, 2024

Nationwide

• Unomedical A/S Osted Aholmvej 1

Philips Azurion Interventional Fluoroscopic X-ray System ... (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands) – potential loss of imaging (x-ray) fun... (2024)

Potential Loss of Imaging (X-ray) Functionality and/or Longer Time to Perform Cold Restart

Moderate

FDAJul 15, 2024Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

DLP Venous Cannulae (Medtronic) – Incorrect Product Placement (2024)

During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrectly placed into a product labeled as DLP Single Stage Venous Cannulae - right angle metal tip (Model 67312).

Low

FDAJul 9, 2024Nationwide• Medtronic Perfusion Systems

Western Star 47X (Western Star) – Tie Rod Assembly Risk (2024)

Daimler Trucks North America, LLC (DTNA) is recalling certain 2025 Freightliner Cascadia, 114SD, Western Star 47X, and 49X transit buses equipped with Composolite EXS20 steerable lift axle suspension assemblies. The tie rod assembly ball stud could have been improperly heat treated and can fail.

High

NHTSAJul 3, 2024Nationwide• WESTERN STAR

Ventana Anti-CD10 Antibody (Ventana) – Staining Inaccuracy (2024)

Their is a potential for high background and off-target staining when using the monoclonal primary antibody which can result in false positive results.

Low

FDAJun 27, 2024Nationwide• Ventana Medical Systems, Inc.

BD Insyte Autoguard IV Catheter (BD) – Tubing Hole Risk (2024)

Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process.

Low

FDAJun 26, 2024IL• Becton Dickinson Infusion Therapy Systems, Inc.

Tech Medical Endo Retrieval Pouch (Unimax) – Tube Fall Risk (2024)

The tube may fall into the surgical site during the grasping process.

High

FDAJun 25, 2024Nationwide• UNIMAX MEDICAL SYSTEMS INC 8F-2, NO

UNITRAX Endoprosthesis Head (Howmedica) – Mislabeling Issue (2024)

Mislabeled: the size on the package label of the UNITRAX Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)

Low

FDAJun 19, 2024Nationwide• Howmedica Osteonics Corp.

SIGNA UHP (GE Medical) - B1+RMS Value Limit (2024)

GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

High

FDAJun 14, 2024Nationwide• GE Medical Systems, LLC

Stay Informed

Inspire Medical Systems Inc. Recalls

Recall Summary

Inspire Model 4063 Stimulation Lead (Inspire) – Labeling Error (2024)

Inspire Model 4340 Respiratory Sensing Lead (Inspire) – Labeling Error (2024)

VariSoft Infusion Set, Single Use. (Unomedical A/S Osted Aholmvej 1) – specific varisofttm infusion sets wer... (2024)

Philips Azurion Interventional Fluoroscopic X-ray System ... (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands) – potential loss of imaging (x-ray) fun... (2024)

DLP Venous Cannulae (Medtronic) – Incorrect Product Placement (2024)

Western Star 47X (Western Star) – Tie Rod Assembly Risk (2024)

Ventana Anti-CD10 Antibody (Ventana) – Staining Inaccuracy (2024)

BD Insyte Autoguard IV Catheter (BD) – Tubing Hole Risk (2024)

Tech Medical Endo Retrieval Pouch (Unimax) – Tube Fall Risk (2024)

UNITRAX Endoprosthesis Head (Howmedica) – Mislabeling Issue (2024)

SIGNA UHP (GE Medical) - B1+RMS Value Limit (2024)

SIGNA Hero (GE Medical) - B1+RMS Value Limit (2024)

Discovery MR950 (GE Medical) - B1+RMS Value Limit (2024)

Optima MR360 (GE Medical) - B1+RMS Value Limit (2024)

SIGNA MR355 (GE Medical) - B1+RMS Value Limit (2024)

Discovery MR750w 3.0T (GE Medical) - B1+RMS Value Limit (2024)

SIGNA Explorer (GE Medical) - B1+RMS Value Limit (2024)

SIGNA PET/MR (GE Medical) - B1+RMS Value Limit (2024)

SIGNA Victor (GE Medical) - B1+RMS Value Limit (2024)

SIGNA Voyager (GE Medical) - B1+RMS Value Limit (2024)