Z-0672-2018Class II

Disposable Curved Circular Staplers

Name: Z-0672-2018 Disposable Curved Circular Staplers
Creator: Ethicon Endo-Surgery Inc
Published: 2017-10-23
License: https://open.fda.gov/license/

Ethicon Endo-Surgery Inc / initiated 2017-10-23 / Terminated

FDA source

Ethicon Endo-Surgery Inc began a recall of Disposable Curved Circular Staplers Product Usage: Staplers have application throughout the alimentary tract for end-to-end, end-to-side, and side-to-side... on 2017-10-23. FDA classified it as Class II and gives the reason as "There is a potential for the devices to create staples that do not meet formed staple height specifications which can result in malformed staples". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0672-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-23
Posted: 2018-02-21
Terminated: 2019-07-18
Recalling firm: Ethicon Endo-Surgery Inc
Product: Disposable Curved Circular Staplers Product Usage: Staplers have application throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.
Product code: GDW Staple, Implantable
Reason for recall: There is a potential for the devices to create staples that do not meet formed staple height specifications which can result in malformed staples.
FDA root cause: Under Investigation by firm
Action: Ethicon Johnson & Johnson Affiliates in Asia Pacific will notify their impacted consignees by providing the customer letter through post, email or sales representative visits. The letter identified the affected product, problems and actions to be taken.
Quantity in commerce: 148.913
Distribution: China
Product codes and lots: CCS25, CCS29

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0672-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0672-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-21

Product code GDW

K983536Class IIProximate Curved and Straight Intraluminal StaplersEthicon Endo-Surgery, Inc. / cleared 1998-12-18

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)