RecallRadar

FDA Device recall Z-0648-2015

PKG, MICRO SCISSORS, STRAIGHT, P/N 0250080269

On 2014-12-24 the FDA classified a Class II recall of PKG, MICRO SCISSORS, STRAIGHT, P/N 0250080269 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-0648-2015
ClassificationClass II
Statusterminated
Initiated2014-11-17
Published2014-12-24
Last updated2026-09-13 11:53 UTC
CompanyStryker Endoscopy
DistributionUS

Product

PKG, MICRO SCISSORS, STRAIGHT, P/N 0250080269. 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_info
842593 843071 843908 844480 1042087 1042653 1042654 1046703 1141794 1142621 1142918 1144316 1144618 114540…842593 843071 843908 844480 1042087 1042653 1042654 1046703 1141794 1142621 1142918 1144316 1144618 1145408 1145972 1240118 1240977 1242391 1243271 1246632 1341583 1343296 1343401 1345285 1346226 1441560 1442811 153299

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-0648-2015%22

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