Reported Dec 24, 2014 · Terminated
PKG, BIPOLAR FORCEPS, MICRO TIP, 45CM, P/N 0250080115 nationwide in US and worldwide: Algeria, Argentina, Australia,…
Stryker Endoscopy
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Endoscopy · 5900 Optical Ct · San Jose, CA · 95138-1400
Is this the product you have?
- PKG, BIPOLAR FORCEPS, MICRO TIP, 45CM, P/N 0250080115
- nationwide in US and worldwideAlgeria, 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
- Lot codes and dates
- Serial/Lot 0915269/0817086 1015777 1016562/1015776 111333/1015777 111333-1015777
- Amount recalled
- 180,573 units total
This recall covers 207 products
The agency filed one notice per product. You are reading one of them; the other 206 are below.
194 more are in the archive.
Where it was sold
- Nationwide
- PR
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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