Z-0488-2015Class III

Cooper Surgical CANNULA-CURETTE 12MM; Model Number: MX562 The CooperSurgical SUCTION CANNULA-CURETTE device...

Name: Z-0488-2015 Cooper Surgical CANNULA-CURETTE 12MM; Model Number: MX562 The CooperSurgical SUCTION CANNULA-CURETTE device...
Creator: CooperSurgical, Inc.
Published: 2014-10-27
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2014-10-27 / Terminated / root cause: packaging

FDA source

CooperSurgical, Inc. began a recall of Cooper Surgical CANNULA-CURETTE 12MM; Model Number: MX562 The CooperSurgical SUCTION CANNULA-CURETTE device is used to remove tissue from within the uterine... on 2014-10-27. FDA classified it as Class III and gives the reason as "The product has been identified to contain an incorrect curette type". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0488-2015
Classification: Class III
Status: Terminated
Initiated: 2014-10-27
Posted: 2014-12-01
Terminated: 2015-05-28
Recalling firm: CooperSurgical, Inc.
Product: Cooper Surgical CANNULA-CURETTE 12MM; Model Number: MX562 The CooperSurgical SUCTION CANNULA-CURETTE device is used to remove tissue from within the uterine cavity on an outpatient basis. The primary uses for this device are for endometrial sampling especially of those patients with a higher risk of cancer. The curettes must be used with a suction pump, as well as sterile tubing, and a swivel handle. The rigid plastic suction curette is sterile and disposable. The Cannula Curette is available in the following styles: Long Curved, Long Straight, and Short Curved.
Product code: HHK Curette, Suction, Endometrial (And Accessories)
Reason for recall: The product has been identified to contain an incorrect curette type.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: CooperSurgical sent an Recall letter dated October 27, 2014, via UPS to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The subject device does not meet the required release specification as it contains an incorrect curette type. No adverse events or injuries have been reported to date in connection with the use of the CANNULA CURETTE. The event was discovered during internal investigation. Products that do not meet the above criteria are safe to use alongside the DFU guideline.The letter requests that customers return the recalled product for a full refund or exchange. If you have any further questions please feel free to call (203) 601.5200.
Quantity in commerce: 30
Distribution: US Distribution including the states of NY, MO and NV.
Product codes and lots: Lot Code: 147234

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0488-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0488-2015	Class III	Terminated	Voluntary: Firm initiated	2014-12-10	2014-12-01

Product code HHK

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)