The Recall Desk
HighFDA (Devices)·Z-0106-2022·Announced 2021-10-20

Ion Flexison Biopsy Needle recalled for potential sheath tip separation

Intuitive Surgical recalled 1,625 Ion Flexison Biopsy Needles due to potential sheath tip separation from the shaft. Affected units are distributed across 29 US states and China; no injuries have been reported.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of a medical device where the sheath tip may separate from the shaft during use. The hazard represents a risk-of-harm scenario for biopsy procedures. No injuries, illnesses, or hospitalizations have been reported, placing this at the High-severity threshold.

Plain-English summary

Intuitive Surgical, Inc. is recalling Ion Flexison Biopsy Needles (19G, extension range 0-3 cm) due to a potential mechanical defect in which the sheath tip may separate from the sheath shaft during use.

The recall affects 1,625 units across 21 lot numbers distributed to hospitals and medical facilities in 29 US states and China. Affected lot numbers are: S90200303, S90200622, S90200727, S90200811, S90200820, S90200831, S90200909, S90201008, S90201015, S90201103, S90201107, S90201125, S90201202, S90201204, S90210114, S90210211, S90210225, S90210310, S90210318, S90210408, and S90210414.

Healthcare providers should immediately stop using affected needles and remove them from inventory. Unused needles should be returned to the manufacturer or disposed of according to institutional protocols. Although sheath separation during a biopsy procedure could potentially cause patient harm, no injuries or illnesses have been reported to the FDA to date.

The recalled product

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
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Surgical / Biopsy Instruments
Hazard
Affected units
1,625

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed in 26 states:

Related recalls

Same manufacturer · Intuitive Surgical, Inc.

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Same hazard · sheath separation

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