RecallRadar

FDA Device recall Z-0657-2015

PKG, GRASPER FORCEPS, NARROW JAW, P/N 0250080287

On 2014-12-24 the FDA classified a Class II recall of PKG, GRASPER FORCEPS, NARROW JAW, P/N 0250080287 by Stryker Endoscopy, citing the parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethyl….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0657-2015
ClassificationClass II
Statusterminated
Initiated2014-11-17
Published2014-12-24
Last updated2026-09-13 11:53 UTC
CompanyStryker Endoscopy
DistributionUS

Product

PKG, GRASPER FORCEPS, NARROW JAW, P/N 0250080287. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

Reason

The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods

Identifiers

code_info848400 941060 944297 945752 1040798 1042479 1042670 1043881 1046197 1142169 1242130 1341574 1341992 1344135 1344687 1344715 1344876 1346231

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-0657-2015%22

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