Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed fo...
FDA Device Recall #Z-1846-2016 — Class II — April 26, 2016
Recall Summary
| Recall Number | Z-1846-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 26, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | STERILMED, INC. |
| Location | Maple Grove, MN |
| Product Type | Devices |
| Quantity | 11,326 |
Product Description
Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive and open surgical procedures to facilitate cutting, preparation, mobilization, and coagulation of tissue. Model #'s MIC3112, MIC3122, MIC3132, MIC3142, MIC3152, MIC3162.
Reason for Recall
Sterlilmed is recalling all unexpired Scissor Tips because of a potential manufacturing defect that can possibly result in a patient injury.
Distribution Pattern
US: AL, AR, CA, CO, FL, GA, IN,IA, KY, MD, MA, MI, MN, MO, NV, NJ, NC, OH, OK, OR, PA,, SC, TN, TX, VA, WA, WV, WI. Canada
Lot / Code Information
Lot Number MIC3112 / 1850033 1851382 1852899 1853678 1855660 1856511 1856900 1859438 1859965 1860367 1861563 1862954 1863647 1864260 1865162 1865993 1867015 1867706 1868934 1870036 1870103 1871206 1872270 1873830 1874518 1875721 1876911 1878327 1879082 1880420 1880667 1880964 1882288 1883924 1884996 1886199 1886912 1887725 1889721 1889771 1890036 1890089 1891061 1891534 1891745 1892678 1893796 1893818 1893872 1894880 1895807 1896467 1897219 1898693 1899180 1900106 1901160 1901950 1903029 1903645 1904549 1905627 1906345 1907168 1907920 1908583 1909201 1910229 1911281 1912196 1912496 1913274 1913316 1914703 MIC3122/ 1850033 1851382 1856511 1856900 1859438 1861563 1868934 1870103 1872882 1875721 1878327 1879082 1896467 1897219 1898693 1899795 1900106 1901160 1903029 1905604 1906345 1907168 1910229 1911281 1912196 MIC3132 / 1850033 1851382 1852883 1852899 1853678 1854157 1856900 1859965 1860367 1861563 1862954 1863647 1864094 1864260 1865993 1867706 1868934 1870036 1870103 1871206 1872882 1874798 1874852 1875721 1878327 1879082 1879555 1880420 1880964 1883924 1884996 1886199 1886912 1887725 1889721 1891061 1891534 1891745 1892678 1899180 1899795 1900106 1901160 1905627 1909201 1910229 1910810 1911873 1912496 1913520 MIC3142 / 1850033 1851382 1852859 1852883 1852899 1852905 1853937 1854157 1855660 1855815 1856511 1856900 1859438 1859745 1859965 1860193 1860367 1861563 1862228 1862954 1863647 1864260 1865162 1865902 1867015 1867706 1868934 1869589 1870103 1871206 1872270 1872882 1873830 1874518 1874798 1875721 1876911 1878327 1879082 1880420 1880667 1880964 1881991 1882288 1883924 1884996 1886199 1886912 1887725 1889044 1889486 1889720 1889721 1889771 1890036 1890089 1891060 1891061 1891745 1892678 1893536 1893796 1893872 1894880 1895806 1895807 1896467 1897219 1898693 1899180 1900106 1900854 1901160 1901950 1903029 1903645 1904549 1905604 1906345 1907009 1907168 1907920 1908583 1909201 1910229 1910810 1911135 1911281 1911873 1912136 1912156 1912184 1912196 1912496 1913221 1913255 1913274 1913316 1913520 1914703 MIC3152 / 1850033 1851382 1852899 1854157 1855660 1856511 1859438 1859965 1860367 1861563 1862954 1863647 1864260 1867015 1867706 1868934 1869589 1870103 1871206 1872270 1872882 1873830 1874852 1875721 1876911 1878327 1879082 1880667 1880964 1882288 1883924 1884996 1886912 1887725 1889044 1889721 1889771 1890036 1890089 1891060 1891061 1891745 1892678 1893796 1893818 1893872 1895806 1895807 1896467 1897219 1898693 1899180 1900106 1901160 1901950 1903029 1903645 1907168 1907920 1908583 1909201 1910229 1910810 1911281 1911873 1912196 1912496 1913221 1913274 1913316 1913520 1914703
Other Recalls from STERILMED, INC.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0573-2026 | Class II | Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ... | Oct 8, 2025 |
| Z-0574-2026 | Class II | Brand Name: Sterilmed Reprocessed Imaging Cathe... | Oct 8, 2025 |
| Z-0090-2019 | Class II | Reprocessed Agilis Steerable Introducer: indic... | Sep 17, 2018 |
| Z-0404-2016 | Class II | Zimmer, Cuff Tourniquet Dual Hose Single Bladde... | Nov 13, 2015 |
| Z-2819-2015 | Class II | Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34"... | Aug 24, 2015 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.