CLASS II Device recall · Reported 3 Dec 2014 · FDA Enforcement Report

Large Hem-o-lok Clip Applier recalled by Intuitive Surgical

Intuitive Surgical is recalling Large Hem-o-lok Clip Applier, distributed in 8 states. The recall was initiated on 3 Nov 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart number; 470230-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.

Quantity recalled509 total units, all affected devices

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-0441-2015
FDA event ID: 69638
Recalling firm: Intuitive Surgical, Sunnyvale, CA
Classification: Class II
Status: Terminated
Recall initiated: 3 Nov 2014
FDA classified: 25 Nov 2014
Reported: 3 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

3 Nov 2014	Recall initiated by company
25 Nov 2014	Classified by FDA	+22 days
3 Dec 2014	Published in enforcement report	+8 days

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

Reason for recall

Not stated in the enforcement report.

Product as listed by the FDA

8MM, LARGE HEM-O-LOK CLIP APPLIER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Where it was distributed

US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.

Florida Indiana Massachusetts Nevada New York Oregon Texas Utah

Questions about this recall

Why was it recalled?

The reason has not been published.

Which lots are affected?

Part number; 470230-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.

Where was it sold?

US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.

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

Other products in this recall event

21 other products · FDA event 69638

This product is part of a recall event; the main page for the event is Resano Forceps,; Intended to assist recalled by Intuitive Surgical.

Reported	Class	Recall	Company	Reason	Where
3 Dec 2014	CLASS II	Resano Forceps,; Intended to assist recalled by Intuitive Surgical	Intuitive Surgical	Potency & Assay	8 states
3 Dec 2014	CLASS II	Micro Bipolar Forceps recalled by Intuitive Surgical	Intuitive Surgical	Potency & Assay	8 states
3 Dec 2014	CLASS II	Permanent Cautery Hook,; Intended to assist recalled	Intuitive Surgical	Potency & Assay	8 states
3 Dec 2014	CLASS II	Cardiac Probe Grasper recalled by Intuitive Surgical	Intuitive Surgical	Potency & Assay	8 states
3 Dec 2014	CLASS II	Potts Scissors recalled by Intuitive Surgical	Intuitive Surgical	Potency & Assay	8 states
3 Dec 2014	CLASS II	Long Tip Forceps recalled by Intuitive Surgical	Intuitive Surgical	Potency & Assay	8 states
3 Dec 2014	CLASS II	Tip-up Fenestrated Grasper recalled by Intuitive Surgical	Intuitive Surgical	Potency & Assay	8 states
3 Dec 2014	CLASS II	Tenaculum Forceps recalled by Intuitive Surgical	Intuitive Surgical	Potency & Assay	8 states
3 Dec 2014	CLASS II	Monopolar Curved Scissors recalled by Intuitive Surgical	Intuitive Surgical	Potency & Assay	8 states
3 Dec 2014	CLASS II	Mega Suturecut Nd recalled by Intuitive Surgical	Intuitive Surgical	Potency & Assay	8 states
3 Dec 2014	CLASS II	Maryland Bipolar Forceps recalled by Intuitive Surgical	Intuitive Surgical	Potency & Assay	8 states
3 Dec 2014	CLASS II	Dual Blade Retractor recalled by Intuitive Surgical	Intuitive Surgical	Potency & Assay	8 states
3 Dec 2014	CLASS II	Medium-large Clip Applier ; Intended to assist recalled	Intuitive Surgical	Potency & Assay	8 states
3 Dec 2014	CLASS II	Curved Bipolar Dissector recalled by Intuitive Surgical	Intuitive Surgical	Potency & Assay	8 states
3 Dec 2014	CLASS II	Black Diamond Micro Forceps recalled by Intuitive Surgical	Intuitive Surgical	Potency & Assay	8 states
3 Dec 2014	CLASS II	Large Needle Driver recalled by Intuitive Surgical	Intuitive Surgical	Potency & Assay	8 states
3 Dec 2014	CLASS II	Permanent Cautery Spatula,; Intended to assist recalled	Intuitive Surgical	Potency & Assay	8 states
3 Dec 2014	CLASS II	Small Grasping Retractor ; Intended to assist recalled	Intuitive Surgical	Potency & Assay	8 states
3 Dec 2014	CLASS II	Prograsp Forceps recalled by Intuitive Surgical	Intuitive Surgical	Potency & Assay	8 states
3 Dec 2014	CLASS II	Fenestrated Bipolar Forceps,; Intended to assist recalled	Intuitive Surgical	Potency & Assay	8 states
3 Dec 2014	CLASS II	Atrial Retractor Short Right ; Intended to assist recalled	Intuitive Surgical	Potency & Assay	8 states

More recalls from Intuitive Surgical

All 256

Reported	Class	Recall	Company	Reason	Where
22 Jul 2026Device	CLASS II	da Vinci SP Instrument Arm Drape, SP recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
1 Jul 2026Device	CLASS II	Da Vinci ASSY, PSS, SP1098 recalled by Intuitive Surgical	Intuitive Surgical	Device Malfunction	Nationwide
10 Jun 2026Device	CLASS II	Da Vinci 5 Assy,DV5 Tower,IS5000 recalled by Intuitive Surgical	Intuitive Surgical	Device Malfunction	49 states
13 May 2026Device	CLASS I	Intuitive SureForm 30 Gray Reloads Reference Numbers recalled	Intuitive Surgical	Other	49 states
13 May 2026Device	CLASS II	Da Vinci X and Da Vinci Xi da Vinci X, Xi Surgical System recalled	Intuitive Surgical	Device Malfunction	Nationwide

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All 3,809

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