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STERILMED, INC. · Model BIOSNDSTR10 · UDI-DI 10888551007115

OWQ Prescription
1
510(k) clearances
266
Adverse events (1 deaths)
10
Recalls
19
Facilities

Description

CATHETER SOUNDSTAR 3D DIAGNOSTIC ULTRASOUND FOR USE ON SIEMENS IMAGING SYSTEM 10FR

Recalls

DateFirmReason
2025-12-22Medline Industries, LPThese lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or
2025-12-22Medline Industries, LPThese lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or
2025-12-22Medline Industries, LPThese lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or
2025-10-08Sterilmed, Inc.Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such a
2025-10-08Sterilmed, Inc.Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such a
2025-07-31Medline Industries, LPSpecific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surface
2025-07-31Medline Industries, LPSpecific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surface
2021-04-26Northeast Scientific Inc.510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles.
2020-03-27Stryker Sustainability SolutionsA subset of temporary intracardiac ultrasound catheters are labeled with the incorrect expiration date. They are mislabeled as having a shelf life of two years, while the actual sh
2014-09-24STERILMED, INC.Sterilmed, a division of Johnson & Johnson Medical NV/SA (Sterilmed), has become aware of an issue affecting certain lots of Reprocessed SOUNDSTAR® eco Diagnostic Ultrasound Cathet

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.