RecallRadar

FDA Device recall Z-2755-2015

Crocodile Grasper

On 2015-09-16 the FDA classified a Class II recall of Crocodile Grasper by Intuitive Surgical, citing in certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2755-2015
ClassificationClass II
Statusterminated
Initiated2015-08-08
Published2015-09-16
Last updated2026-09-13 11:53 UTC
CompanyIntuitive Surgical
DistributionUS

Product

Crocodile Grasper; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428059-12, 428059-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port.

Reason

In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position.

Identifiers

code_infoModel numbers: 428059-12, 428059-13; all lots

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2755-2015%22

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