Vortex Surgical Recalls Rumex Disposable Diamond Dusted ILM Elevator Over Sterility Concerns

What Happened

Vortex Surgical Inc. has initiated a voluntary recall of the Rumex Disposable Diamond Dusted ILM Elevator. The company identified that there may be voids located in the seals of the Tyvek pouches used to package the devices. A compromised sterile barrier presents a potential for bioburden contamination, which could lead to serious infections in patients during surgical procedures.

Which Products Are Affected

The recall affects the following medical device:

• Product Name: Rumex Disposable Diamond Dusted ILM Elevator, 12-7523
• Recall Number: Z-1253-2026
• Lot Number: 2411033
• UDI Codes: Pouch UDI 5060720920298; Box UDI 5060720920298
• Quantity: 14,789 units (8,651 in the United States; 6,138 internationally)

In the United States, the product was distributed to the following states: 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, and VA. International distribution included Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, and Vietnam.

What You Should Do

Vortex Surgical Inc. notified affected customers via letter starting on December 16, 2025. Healthcare providers and facilities should immediately check their inventory for Lot 2411033. Affected products should be quarantined and not used in clinical settings. For information regarding the return or replacement of these devices, contact Vortex Surgical Inc. at their headquarters in Saint Charles, Missouri.

Why This Matters

A breach in the sterile packaging of a surgical instrument can introduce bacteria or other contaminants directly into a patient’s body, posing a high risk of post-operative infection and related health complications.

Source

This information is based on official recall data provided by the FDA.