Product Safety Recalls

Product Recall Tracker

Intuitive Surgical, Inc. Recall 88524

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

Intuitive Surgical, Inc. Recall 88524 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0106-2022
Event ID88524
Event DescriptionIon Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978
Product TypeDevices
DistributionUS: 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
Quantity1625 units
Recall ReasonPotential for the sheath tip on the biopsy needle to separate from the sheath shaft.
Device Classification20211020
Device Code InfoAffected Lot Number(s): S90200303, S90200622, S90200727, S90200811, S90200820, S90200831 ,S90200909, S90201008, S90201015 ,S90201103, S90201107, S90201125 ,S90201202, S90201204, S90210114 ,S90210211, S90210225, S90210310 ,S90210318, S90210408, S90210414
Center Classification Date20211013
Recall Initiation Date20210806
Recalling FirmIntuitive Surgical, Inc.
Initial Notification Letter
Similar To

© 2022 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.