CooperSurgical, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1131-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical 2 MHz Waterproof OB probe is for obstetrical use in the labor and department for late term obstetrical examination associated with larger women. The product detects fetal heart beats as an aid for determining fetal viability.

Product Classification:

Class II

Date Initiated: October 6, 2017

Date Posted: March 28, 2018

Recall Number: Z-1131-2018

Event ID: 79213

Reason for Recall:

The 2MHZ prove was incorrectlhttp://cts.fda.gov/division-tracking/images/trash.pngy labeled as a 3MHZ probe

Status: Terminated

Product Quantity: 13 units

Code Information:

SIN 2017070001 SIN 2017070008 SIN 2017070002 SIN 2017070009 SIN 2017070003 SIN 2017070010 SIN 2017070004 SIN 2017070011 SIN 2017070005 SIN 2017070012 SIN 2017070006 SIN 2017070013 SIN 2017070007

Distribution Pattern:

Worldwide Distribution - US Nationwide and the countries of ( Canada and England)

Voluntary or Mandated:

Voluntary: Firm initiated