Intuitive Surgical, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0106-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978

Product Classification:

Class II

Date Initiated: August 6, 2021

Date Posted: October 20, 2021

Recall Number: Z-0106-2022

Event ID: 88524

Reason for Recall:

Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.

Status: Terminated

Product Quantity: 1625 units

Code Information:

Affected Lot Number(s): S90200303, S90200622, S90200727, S90200811, S90200820, S90200831 ,S90200909, S90201008, S90201015 ,S90201103, S90201107, S90201125 ,S90201202, S90201204, S90210114 ,S90210211, S90210225, S90210310 ,S90210318, S90210408, S90210414

Distribution Pattern:

US: AZ, AR, CA, CO, DC, FL, GA, IL, IN, IO, MD, MA, MI, MN, MO, NV, NJ, NY, NC, OH, OK, PA, TN, TX, UT, VA, WA OUS: China

Voluntary or Mandated:

Voluntary: Firm initiated