Z-1131-2018Class II

Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical 2 MHz Waterproof OB probe is for...

Name: Z-1131-2018 Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical 2 MHz Waterproof OB probe is for...
Creator: CooperSurgical, Inc.
Published: 2017-10-06
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2017-10-06 / Terminated / root cause: labeling and UDI

FDA source

CooperSurgical, Inc. began a recall of 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... on 2017-10-06. FDA classified it as Class II and gives the reason as "The 2MHZ prove was incorrectlhttp://cts.fda.gov/division-tracking/images/trash.pngy labeled as a 3MHZ probe". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1131-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-06
Posted: 2018-03-19
Terminated: 2020-02-06
Recalling firm: CooperSurgical, Inc.
Product: 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 code: KNG Monitor, Ultrasonic, Fetal
Reason for recall: The 2MHZ prove was incorrectlhttp://cts.fda.gov/division-tracking/images/trash.pngy labeled as a 3MHZ probe
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: CooperSurgical sent an Urgent Medical Device Recall letter dated October 6, 2017 to affected customers via UPS with confirmed delivery receipt. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to discontinue use of affected products and complete the attached Acknowledgement and Receipt Form for replacement. If you have any further questions please feel free to contact me at 203.601.5200.
Quantity in commerce: 13 units
Distribution: Worldwide Distribution - US Nationwide and the countries of ( Canada and England)
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1131-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1131-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-19

Product code KNG

K024197Class IILifedop DopplerSummit Doppler Systems, Inc. / cleared 2003-01-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)