FDA-Device2026-02-11Class IIPACKAGING DEFECT
Vortex Surgical Rumex ILM Elevator recalled for compromised sterile packaging
What this means
Vortex Surgical Inc. is recalling certain lots of the Rumex Disposable Diamond Dusted ILM Elevator (catalog 12-7523) because the sterile packaging may have small voids in the seal. A compromised seal could allow bacteria or other contaminants to reach the surgical instrument, potentially leading to infection if used.
- Check if you have Lot 2411033 with UDI 5060720920298
- Do not use affected instruments; contact your supplier or Vortex Surgical for instructions on return or replacement
- Notify any patients who may have received surgery with affected instruments from this lot
The agency's original wording
Hazard
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CT, FL, HI, IA, IL, IN, KY, MA, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WI, VA; and OUS (foreign) to countries of: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam.
Affected count
14,789 (8651 US; 6138 OUS)
Manufactured in
4 Research Park Dr Ste 124, N/A, Saint Charles, MO, United States
Products
Rumex Disposable Diamond Dusted ILM Elevator, 12-7523
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1253-2026Want us to check the next one for you?
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