Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only,
FDA Recall Z-1539-2024 · Posted 2024-04-12
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Reason for Recall
Firm Action
Root Cause
Material/Component Contamination
Distribution Pattern
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Belize, Bolivia, Burkina Faso, Burundi, Cambodia, Canada, Chile, Colombia, Congo, The Democratic Republic of, Costa Rica, Cyprus, Czech Republic, Ethiopia, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Indonesia, Israel, Italy, Japan, Lesotho, Mozambique, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Poland, Puerto Rico, Qatar, Rwanda, Saudi Arabia, Senegal, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Tanzania, United Republic Of, Thailand, Trinidad And Tobago, Uganda, United Kingdom, Uruguay, Yemen, Zimbabwe.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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