Food, drugs, devices › Intuitive Surgical, Inc.
Device recall: EndoWrist Stapler System User Manual Addendum and Wall Chart; The EndoWrist Stapler 45 System and EndoWrist Stapler 45 R
Intuitive Surgical, Inc. (Sunnyvale, CA) initiated this device recall on 2 Jun 2014; FDA lists 1 product record under event 68814, classified Class II.
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. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 8 Aug 2014. Initiation: voluntary: firm initiated. Intuitive Surgical, Inc. has 105 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
Intuitive Surgical, Inc., Sunnyvale, CA.
Reason for recall
"Changes were made to the Stapler EndoWrist Stapler 45 System Instruments and Accessories User Manual Addendum (550986-03) and the EndoWrist Stapler 45 Wall Chart (PN 551524-01) in which the pH range specification for the enzymatic cleaner used throughout the cleaning process was modified from pH-neutral to pH-neutral to mild alkaline (mild alkaline is defined as pHd11). Mild Alkaline enzymatic"
Distribution
"Distribution to Florida and South Carolina"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2171-2014 | EndoWrist Stapler System User Manual Addendum and Wall Chart; The EndoWrist Stapler 45 System and EndoWrist Stapler 45 Reloads are intended to be used with the da Vinci Si Surgical System (Model IS3000) for resection, transection and/or creation of anastomoses in General, Gynecologic and Urologic surgery. The device… | 2 | Class II | Terminated | 20 Aug 2014 |
Context
Other enforcement events for Intuitive Surgical, Inc.
All 105 events for Intuitive Surgical, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Changes were made to the Stapler EndoWrist Stapler 45 System Instruments and Accessories User Manual Addendum (550986-03) and the EndoWrist Stapler 45 Wall Chart (PN 551524-01) in which the pH range specification for the enzymatic cleaner used throughout the cleaning process was modified from pH-neutral to pH-neutral to mild alkaline (mild alkaline is defined as pHd11). Mild Alkaline enzymatic"
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: "Distribution to Florida and South Carolina"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 8 Aug 2014. "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.