Z-0106-2022Class II

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

Name: Z-0106-2022 Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO...
Creator: Intuitive Surgical, Inc.
Published: 2021-08-06
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2021-08-06 / Terminated

FDA source

Intuitive Surgical, Inc. began a recall of Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978 on 2021-08-06. FDA classified it as Class II and gives the reason as "Potential for the sheath tip on the biopsy needle to separate from the sheath shaft". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0106-2022
Classification: Class II
Status: Terminated
Initiated: 2021-08-06
Posted: 2021-10-15
Terminated: 2024-05-17
Recalling firm: Intuitive Surgical, Inc.
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
Product code: EOQ Bronchoscope (Flexible Or Rigid)
Reason for recall: Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.
FDA root cause: Under Investigation by firm
Action: 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: [email protected].
Quantity in commerce: 1625 units
Distribution: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0106-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0106-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-20	2021-10-13

Product code EOQ

K182188Class IIIon Endoluminal System ; Flexision Biopsy NeedleIntuitive Surgical / cleared 2019-02-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)