FDA Medical devices recall ·
DORO¿ Easy-Connect Navigation Adaptor recall
- Recall number
- Z-1860-2025
- Date
- (initiated March 14, 2025)
- Company / brand
- Pro-Med Instruments Gmbh
BOETZINGER STRASSE 86, Freiburg Im Breisgau, N/A, Germany - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 217 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
Why was it recalled?
Potential of compromised compatibility resulting in influence on the positioning of the reference array and an influence of the function of the navigation system cannot be excluded.
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
Model/Item No: 1204.002; UDI-DI: 04250435506738; Serial numbers: 1102010, 1201002, 1201004, 1201005, 1201006, 1201008, 1201009, 1201011, 1206012, 1206013, 1206014, 1206015, 1206016, 1206018, 1310001, 1310002, 1310003, 1312001, 1312002, 1312003, 1312004, 1312005, 1312006, 1312007, 1312008, 1312009, 1312010, 1407011, 1407012, 1407013, 1407014, 1407015, 1407016, 1407017, 1407018, 1407019, 1407020, 1501026, 1501027, 1501028, 1501029, 1501030, 1503031, 1503032, 1503033, 1503034, 1503035, 1503035, 1503036, 1503037, 1503038, 1503039, 1503040, 1505041, 1505042, 1505043, 1505044, 1505045, 1505046, 1505047, 1505048, 1505049, 1505050, 1506051, 1506052, 1506053, 1506054, 1507055, 1509056, 1509057, 1509058, 1509059, 1509060, 1509061, 1509062, 1509063, 1509064, 1509065, 1605066, 1605067, 1605068, 1605069, 1605070, 1605071, 1605072, 1605073, 1605074, 1605075, 1610078, 1610079, 1610080, 1610081, 1610082, 1610083, 1610084, 1610085, 1610086, 1708001, 1708002, 1708003, 1708004, 1708005, 1708006, 1708007, 1708008, 1708009, 1708010, 1801011, 1801012, 1801013, 1802014, 1802015, 1802016, 1802017, 1802018, 1802019, 1802020, 1805021, 1805022, 1805023, 1805024, 1805025, 1806026, 1806027, 1806028, 1806029, 1806030, 1807031, 1807032, 1807033, 1807034, 1811036, 1811037, 1811038, 1811039, 1811040, 1902001, 1902002, 1902003, 1902004, 1902005, 1902006, 1902007, 1902008, 1902009, 1902010, 1910001, 1910002, 1910003, 1910004, 1910005, 1910006, 1910007, 1910008, 1910009, 1910010, 2007001, 2007002, 2007003, 2007
Distribution
Worldwide - US Nationwide distribution in the states of CA, CO, KY, ID, IL, MA, MO, NC, NJ, NY, TX and the countries of Algeria, Argentina, Australia, Austria, Brazil, Burma, China, Colombia, Cyprus, Czech Republic, Ecuador, Egypt, France, Germany, Hungary, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Mexico, Mongolia, Netherlands, Norway, Philippines, Poland, Qatar, Russia, Russia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom.
States: California Colorado Idaho Illinois Kentucky Massachusetts Missouri North Carolina New Jersey New York Texas
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-1860-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.