CLASS II Device recall · Reported 23 Sep 2015 · FDA Enforcement Report

Fluorescence Imaging Procedure Kits used recalled by Intuitive Surgical

Intuitive Surgical is recalling Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems, distributed nationwide in the US. The recall was initiated on 9 Sep 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct number: 950156-01: Lot numbers: NQ141201 NQ141502 NQ142201 NQ142901 NQ143201 NQ143301. Product number 950156-02: Lot numbers: NQ143501 NQ143502 NQ143601 NQ143602 NQ143803 NQ143901 NQ143902. Product number 950156-03: Lot numbers : NQ144001 NQ150501 NQ143902 NQ150601 NQ143901 NQ150602 NQ143803 NQ150703 NQ143601 NQ150701 NQ143602 NQ150702 NQ144502 NQ150801 NQ144801 NQ150901 NQ145202 NQ150802 NQ144901 NQ151001 NQ145301 NQ151002 NQ145201 NQ151101 NQ150301 NQ150501 NQ144001.

Quantity recalled1200 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2782-2015
FDA event ID: 72158
Recalling firm: Intuitive Surgical, Sunnyvale, CA
Classification: Class II
Status: Terminated
Recall initiated: 9 Sep 2015
FDA classified: 17 Sep 2015
Reported: 23 Sep 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Surgical Instruments

Timeline

9 Sep 2015	Recall initiated by company
17 Sep 2015	Classified by FDA	+8 days
23 Sep 2015	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

B. Braun 2 gang 4-way stopcocks in the Fluorescence Imaging Procedure Kit may experience damage to the sterile packaging during shipping. The damage can result in tears to the packaging and has the potential to cause a breach in sterility of the supplied stopcocks.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems; Model numbers: 950156-01, 950156-02, 950156-03. Product Usage: General and plastic surgery: The da Vinci Firefly Imaging system is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging.

Where it was distributed

US Nationwide Distribution

Nationwide

Questions about this recall

Is Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems recalled?

Yes. Intuitive Surgical recalled Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems on 9 Sep 2015. The recall is Class II and its status is Terminated. Recall number Z-2782-2015.

Why was it recalled?

Which lots are affected?

Product number: 950156-01: Lot numbers: NQ141201 NQ141502 NQ142201 NQ142901 NQ143201 NQ143301. Product number 950156-02: Lot numbers: NQ143501 NQ143502 NQ143601 NQ143602 NQ143803 NQ143901 NQ143902. Product number 950156-03: Lot numbers : NQ144001 NQ150501 NQ143902 NQ150601 NQ143901 NQ150602 NQ143803 NQ150703 NQ143601 NQ150701 NQ143602 NQ150702 NQ144502 NQ150801 NQ144801 NQ150901 NQ145202 NQ150802 NQ144901 NQ151001 NQ145301 NQ151002 NQ145201 NQ151101 NQ150301 NQ150501 NQ144001.

Where was it sold?

US Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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