CLASS II Device recall · Reported 28 Feb 2018 · FDA Enforcement Report

Disposable Curved Circular Staplers recalled by Ethicon Endo-Surgery

Ethicon Endo-Surgery is recalling Disposable Curved Circular Staplers. The recall was initiated on 23 Oct 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCCS25, CCS29

Quantity recalled148.913

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0672-2018
FDA event ID: 79246
Recalling firm: Ethicon Endo-Surgery, Blue Ash, OH
Classification: Class II
Status: Terminated
Recall initiated: 23 Oct 2017
FDA classified: 21 Feb 2018
Reported: 28 Feb 2018
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

23 Oct 2017	Recall initiated by company
21 Feb 2018	Classified by FDA	+121 days
28 Feb 2018	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

China

Questions about this recall

Is Disposable Curved Circular Staplers recalled?

Yes. Ethicon Endo-Surgery recalled Disposable Curved Circular Staplers on 23 Oct 2017. The recall is Class II and its status is Terminated. Recall number Z-0672-2018.

Why was it recalled?

There is a potential for the devices to create staples that do not meet formed staple height specifications which can result in malformed staples.

Which lots are affected?

CCS25, CCS29

Where was it sold?

China

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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