RecallRadar

FDA Device recall Z-0592-2015

PKG, BIPOLAR FORCEPS, MICRO TIP, 45CM, P/N 0250080115 nationwide in US and worldwide: Algeria, Argentina, Australia, Bolivia, Brazil, Canad…

On 2014-12-24 the FDA classified a Class II recall of PKG, BIPOLAR FORCEPS, MICRO TIP, 45CM, P/N 0250080115 nationwide in US and worldwide: Algeria, Argentina, Australia, Bolivia, Brazil, Canad… 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-0592-2015
ClassificationClass II
Statusterminated
Initiated2014-11-17
Published2014-12-24
Last updated2026-09-13 11:53 UTC
CompanyStryker Endoscopy
DistributionUS

Product

PKG, BIPOLAR FORCEPS, MICRO TIP, 45CM, P/N 0250080115 nationwide in US and worldwide: Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Venezuela

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_infoSerial/Lot 0915269/0817086 1015777 1016562/1015776 111333/1015777 111333-1015777

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-0592-2015%22

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