FDA Medical devices recall · December 10, 2025

Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841 recall

Read the official FDA notice ↗

Product

Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,

Why was it recalled?

Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

UDI:700884838103405, 00884838120266, 00884838064713, 00884838108455 / Serial Numbers: USD21L1900 US122L0603 USD21L1901 USD21L1722 US122L1176 USD21L1720 US122L1175 US122L1186 US122L0415 US122L1174 USD21L1587 USD21L1586 USD21L1416 USD21L2073 USD21L1589 USD21L1721 US122L1177 US122L1305 US122L0996 USD21L1588 US122L1190 US122L1183 US122L0416 US122L1671 US122L0523 USD21L1719 US122L0522 US122L1048 USD21L1417 US122L1856 US122L1854 US122L1852 US122L1376 US122L1310 US122L0040 US122L1289 US122L1673 US122L0602 USD21L1590 US122L1307 USD21L2052 US122L1311 US122L0038 US122L1309 USO21L0079 US122L1855 USO21L0048 US921L1762 USO21L0046 USO21L0017 USO21L1376 US921L1485 USO21L0045 US921L1331 US921L1694 USO21L0038 USO21L0039 US921L1761 USO21L0040 US921L1760 US921L1759 US921L1695 US921L1609 USO21L0044 USO21L0078 USO21L0050 USO21L0015 US921L1610 USO21L0003 USO21L0043 US921L1484 USO21L1495 USO21L0093 USO21L1374 USO21L1373 USO21L1755 USO21L0081 USO21L0119 USO21L1667 USO21L0579 USO21L0083 USD21L2046 USO21L1375 USO21L0042 US921L1330 USO21L0041 US921L1693 USO21L0036 USO21L1753 USO21L0049 USO21L0037 US921L1696 USO21L0016 USO21L0047 USO21L0764 USO21L0080 USD21L2054 USD21L0049 USD21L0036 USD21L0037 USO21L0082 USD21L2049 USD21L2055 USD21L2051 USD21L2047 USD21L2239 USD21L0055 USD21L2153 USD21L0068 US122L0037 USD21L0039 USD21L0053 USD21L0056 US622L0962 USD21L0040 USD21L2048 USO21L0578 USD21L0050 USD21L0051 USD21L0052 USD21L0066 USD21L0704 USD21L0054 USD21L0524 US821L0816 US821L0583 US821L0586 US821L0246 US821L

Distribution

Worldwide US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR and the countries of Argentina, Armenia, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Czech Republic, Dominican Rep, Ecuador, El Salvador, Estonia, France, Germany, Greece, Guatemala, Honduras , Hungary, Iceland, India, Indonesia, Israel, Italy, Jordan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Singapore, Slovakia, South Africa, South Korea, Spain, St. Pier/Miquel., Sweden, Switzerland, Taiwan, Thailand, Trinidad/Tobago, Tunisia, T¿rkiye, United Kingdom, Uruguay, Vietnam.

States: Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi Montana North Carolina Nebraska New Hampshire New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Virginia Vermont Washington Wisconsin West Virginia Wyoming

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-0883-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.