Z-1879-2018Class II

Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151

Name: Z-1879-2018 Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151
Creator: CooperSurgical, Inc.
Published: 2018-03-12
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2018-03-12 / Terminated / root cause: packaging

FDA source

CooperSurgical, Inc. began a recall of Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151 on 2018-03-12. FDA classified it as Class II and gives the reason as "Products have been packaged with an incorrect product size". 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-1879-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-12
Posted: 2018-05-15
Terminated: 2019-05-08
Recalling firm: CooperSurgical, Inc.
Product: Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151
Product code: HGI Electrocautery, Gynecologic (And Accessories)
Reason for recall: Products have been packaged with an incorrect product size.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: On March 26, 2018 CooperSurgical mailed medical device recall notification letters to affected customers. Customers were instructed to: please discontinue use of any of the lots listed in the table above and complete the attached Acknowledgement and Receipt Form to schedule refund or exchange. If you have supplied or transferred any potentially affected product to another facility or organization, please let them know of the recall by providing a copy of this letter. If you have any further questions, please feel free to contact CooperSurgical at [email protected].
Quantity in commerce: 500
Distribution: CA, SC, WI, MI, NH, MD, OH, NJ, Australia, France, Spain
Product codes and lots: Lot number: 212074

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1879-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1879-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-05-15

Product code HGI

K061651Class IIFischer Cone Biopsy Excisor, Models 900-150, 151, 152, 154, 155, 157 and 158Apple Medical Corp. / cleared 2006-10-20

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)