Intuitive Surgical, Inc. Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978
Brand
Intuitive Surgical, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
Intuitive Surgical, Inc. is recalling Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Ster due to Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.
Recommended Action
Per FDA guidance
On August 6, 2021, Intuitive Surgical issued an "Urgent Medical Device Recall" notice to affected consignees via Fed Ex. In addition to informing consignees about the recall, Intuitive ask consignees to take the following actions: 1. Inform necessary hospital personnel about this issue. 2. Inform affected personnel when the requested actions have been completed. 3. Complete the attached Acknowledgement Form immediately and return it via fax or email to Intuitive as instructed on the form. 4. Please retain a copy of this letter and the acknowledgement form for your files. 5. All returned affected product will be assessed and credit will be provided for the quantity returned. Intuitive will provide a follow up notification once unaffected product becomes available. 6. If you need further information or support concerning this Medical Device Notification, please contact your Endoluminal Sales Representative or contact Intuitive Customer Service at the numbers listed below: " North America: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customerservice@intusurg.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, AR, CA, CO, FL, GA, IL, IN, MD, MA, MI, MN, MO, NV, NJ, NY, NC, OH, OK, PA, TN, TX, UT, VA, WA, DC
Page updated: Jan 10, 2026