FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 3801–3820 of 39,430 recalls

Class IIOngoing

Baxter TruSystem 7500, Product Code 4091000

Baxter Healthcare Corporation

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.

February 25, 2025 · DeviceView details →

Class IIOngoing

Baxter Stationary column TruSystem 7500, Product Code 1717020

Baxter Healthcare Corporation

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.

February 25, 2025 · DeviceView details →

Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices.

A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.

FDA Device Recalls

Baxter TruSystem 7500, Product Code 4091000

Baxter Stationary column TruSystem 7500, Product Code 1717020

Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices.

Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204

Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086

Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S

Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number 5400-020-008ITL

Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL

Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plus 4cm Catalog Number 5400-030-004ITL

Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore Forte plus 8cm Catalog Number 5400-030-008ITL

Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number 5400-020-004ITL

Baxter Stationary column TruSystem 7500 U, Product Code 1730731

Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITL

Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886

Baxter Operating table column TS7500 MOBIUS, Product Code 1704695

Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other complications associated with immobility, Product Codes P7520A19, P7520A20S, P7520A21, P7520A22S, P7520A23, P7520A24S, P7520A3, P7520A31, P7520A37, P7520A39, P7520A45, and P7520A4S.

Baxter TruSystem 7500 Hybrid (FC), Product Code 1854085

Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S

Baxter TruSystem 7500 Hybrid Plus (SC), Product Code 1854088

Baxter Floor mounting column TruSystem 7500, Product Code 1717021