Endoplus recallZ-2265-2013 · Endoplus, Inc. · initiated Jul 15, 2013
Class II Terminated All recalls posted in September 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Endoplus, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures.
FDA root cause category: Process control
What the company is doing
Letters were sent on 7/15/2013 to all customers notifying them of the recall. The letters requested that customers return the recalled devices via private courier using an enclosed account number. Replacement devices will be made available upon customer request.
Recall details
- Recall number
- Z-2265-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 15, 2013
- Posted by the FDA
- Sep 21, 2013
- Recalling firm
- Endoplus, Inc.
- Quantity
- 9 units
- Product code
- GCJ
- FDA submissions
- K925079
- Distribution
- Distributed in the states of FL, TX, and VA.
Product description
ENDOPLUS; Precision Laparoscopic Instruments; REF 345VA; Description 5 mm Traumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA. Intended for grasping, dissecting, retraction, clamping in conjunction with the laparoscopic during laparoscopic surgery.
Code information (models, lots, serial numbers)
Item: 345VA; Lot Number: F3
Other devices under the same FDA submission
1 device cleared under K925079 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Endoplus E346SLEndoplus · Laparoscope, Gynecologic (And Accessories)1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 66063).
- Z-2264-2013 · TerminatedENDOPLUS; Precision Laparoscopic Instruments; REF 346VA; Description 5mm Atraumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelei…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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