Stryker recalls sterile StrykeFlow 2 surgical suction/irrigator systems with higher-than-acceptable bioburden levels in certain lots. Affected units include specific models and lot numbers. Consumers should contact Stryker for details.
Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
Stryker is recalling sterile surgical suction and irrigation systems that tested with higher-than-acceptable bioburden levels in some batches. This could pose a risk of infection during medical procedures if the products are used without proper sterilization.
Bioburden refers to the amount of microorganisms in a sterile product. Higher levels than acceptable could lead to infections if the device is not properly sterilized before use in medical procedures.
Medical professionals using the StrykeFlow 2 system for surgeries are most at risk. Patients using these devices during procedures may face infection risks if the products are not properly sterilized.
Check for model numbers 0250070500, 0250070505, or 0250070520 on the product. Affected lots include specific numbers like 17275FG2 through 17302FG2 as listed in the recall notice.
Identify the model number and lot number on the device to confirm if it is affected by this recall.
Stryker found that certain lots of the StrykeFlow 2 system had higher-than-acceptable bioburden levels during routine testing.
Check the model number (0250070500, 0250070505, or 0250070520) and lot number (e.g., 17275FG2 through 17302FG2) on the device.
Contact Stryker directly for instructions on how to handle the affected product, as the recall does not specify a return or replacement process.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-0835-2018 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-0835-2018 from Stryker. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
