Food, drugs, devices › Ethicon Endo-Surgery Inc
Device recall: Disposable Curved Circular Staplers Product Usage: Staplers have application throughout the alimentary tract for end-to-
FDA enforcement event 79246 is a device recall by Ethicon Endo-Surgery Inc of Blue Ash, OH, initiated 23 Oct 2017 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 18 Jul 2019. Initiation: voluntary: firm initiated. Ethicon Endo-Surgery Inc has 26 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Ethicon Endo-Surgery Inc, Blue Ash, OH.
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."
Distribution
"China"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0672-2018 | 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. | 148.913 | Class II | Terminated | 28 Feb 2018 |
Context
Other enforcement events for Ethicon Endo-Surgery Inc
All 26 events for Ethicon Endo-Surgery Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "China"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 18 Jul 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.