STERILMED, INC.: Medical Device Recall in 2014 - (Recall #: Z-0059-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577.

Product Classification:

Class II

Date Initiated: September 24, 2014

Date Posted: October 15, 2014

Recall Number: Z-0059-2015

Event ID: 69337

Reason for Recall:

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 Catheters for which Sterilmed is the reprocessor and Biosense Webster is the distributor. Sterilmed determined that the units of these lots were incorrectly processed and as a result when the affected catheter is conne

Status: Terminated

Product Quantity: 22

Code Information:

Lot Numbers: 1717945, 1721574, 1721575 and 1723123 Catalog Nos: M-5723-115, Model Number BIO10438577

Distribution Pattern:

US Distribution including the states of WA and CA.

Voluntary or Mandated:

Voluntary: Firm initiated