Class II U.S. Food and Drug Administration

Intuitive Surgical, Inc. Brand Name: da Vinci S, Si Mega Needle Driver Instrument recall: Due to increased complaints for broken/frayed grip cables for reusable

Recall published 7 months ago

Due to increased complaints for broken/frayed grip cables for reusable instruments.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: Due to increased complaints for broken/frayed grip cables for reusable instruments.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1698-2026
Published
April 8, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Intuitive Surgical, Inc.
Product type
Medical devices
Units affected
7819
Distribution
Nationwide
Made in
United States
Lot / code info
Lot Code: 420194, Mega Needle Driver GTIN: 00886874111611 FDA Medical Device Listing Number: D088920 Material Number: 420194-08 Batch / System Numbers: M10120201 SH1182 M20120412 SH1182 M10130121 SH1570 M10130306 SH1570 M10110602 SH0547 M10110627 SH0547 M10121129 SH0059 M10121214 SH0059 M10130429 SH0059 M10130521 SH0059 M10121105 SH1557 M10130517 SH1837 M10121109 SH1390 M10130508 SH1390 M10131004 SH1390 M10130306 USG689 M10130412 USG689 M10110302 SH1368 M10110614 SH1368 M10110620 SH1368 M10110817 SH1368 M10120705 SH1368 M10121022 SH1368 M10130429 SH1368 M10130509 SH1368 M10130722 SH1368 M10110131 USG294 M10110511 USG294 M10110616 USG294 M10110811 USG294 M10111003 USG294 M20111103 USG294 M10111206 USG294 M20120103 USG294 M10120130 USG294 M10120305 USG294 M10120425 USG294 M10120713 USG294 M10121004 USG294 M10121017 USG294 M10121022 USG294 M10121105 USG294 M10121107 USG294 M10121206 USG294 M10121207 USG294 M10130108 USG294 M10130112 USG294 M10130201 USG294 M10130213 USG294 M10130215 USG294 M10130529 USG294 M11130608 USG294 M10130718 USG294 M10130829 USG294 M10120321 SG2026 M10120605 SG2026 M10111114 SH0825 M10110330 SH0935 M10110401 SH0935 M10120123 SH0935 M10120313 SH0935 M10120404 SH0935 M10120802 SH0935 M10120919 SH0935 M10121121 SH0935 M10110302 SH0729 M10110503 SH0729 M10110701 SH0729 M10110809 SH0729 M10110817 SH0729 M10110825 SH0729 M10110913 SH0729 M10110923 SH0729 M10111116 SH0729 M20111123 SH0729 M10111201 SH0729 M10120120 SH0729 M10120130 SH0729 M10120210 SH0729 M10120217 SH0729 M10120301 SH0729 M10120412 SH0729 M10120507 SH0729 M10120525 SH0729 M20120530 SH0729 M10120703 SH0729 M10120724 SH0729 M10120803 SH0729 M10120810 SH0729 M10120827 SH0729 M10121025 SH0729 M10130102 SH0729 M10130212 SH0729 M10130213 SH0729 M10130314 SH0729 M10130418 SH0729 M10130517 SH0729 M10130603 SH0729 M10130606 SH0729 M10130617 SH0729 M10130701 SH0729 M10131014 SH0729 N10140430 SH0729 M10101206 SH0035 M10110624 SH0035 M10101206 SH1391 S10110307 SH1391 M10110302 SH1391 M10110701 SH1391 M10120404 SH1391 M10120705 SH1391 M10121010 SH1391 M10130118 SH1391 M10130125 SH1391 M10130515 SH1391 M10130626 SH1391 M10121206 SH1604 M10130308 SH1604 M10101127 SH0495 M10101217 SH0495 M10110131 SH0495 M10110512 SH0495 M10110817 SH0495 M10110901 SH0495 M10111008 SH0495 M20111221 SH0495 M10120217 SH0495 M10120224 SH0495 M10110527 SH0495 M10120727 SH0495 M10121004 SH0495 M10130102 SH0495 M10130213 SH0495 M10130301 SH0495 M10130812 SH0495 M10130924 SH0495 M10111201 SH1015 M10111208 SH1015 M10120217 SH1015 M10120425 SH1015 M10120618 SH1015 M10120713 SH1015 M10120823 SH1015 M10120827 SH1015 M10121022 SH1015 M10130212 SH1015 M10130213 SH1015 M10130828 SH1015 M10120831 SH1385 M10120918 SH1385 M10110412 SH2144 M10110706 SH2144 M10110923 SH2144 M10111008 SH2144 M10111205 SH2144 M20120103 SH2144 M10120210 SH2144 M10120713 SH2144 M10121121 SH2144 M10130325 SH2144 M10130529 SH2144 M10110302 SH0761 M10121129 SH0761 M10130719 SH0761 M10131001 SH0761 M20120322 SH1276 M10120525 SH1276 M10130503 USG518 M10130821 USG518 M10130828 USG518 M10131014 USG518 Material Number: 420194-10 Batch / System Numbers: N10170714 SH1182 N10170817 SH1182 N10171019 SH1182 M10140303 SH1570 N10140805 SH1570 N10150702 SH1570 N10160311 SH1570 N10160421 SH1570 N10161206 SH1570 N10161223 SH1570 N10180227 SG704 M10131121 SH0547 N10140609 SH0547 M10140221 SH0059 M10140307 SH0059 N10140508 SH0059 N10140827 SH0059 N10150320 SH0059 N10160519 SH0059 N10160728 SH0059 N11160907 SH0059 N11161013 SH0059 N10161129 SH0059 N10170419 SH0059 N11170407 SH0059 N10170612 SH0059 N10170705 SH0059 N10180202 SH0059 N10180323 SH0059 N10180321 SH0059 N10180412 SH0059 M10140225 SH1557 N10140605 SH1557 N10140620 SH1557 N10140827 SH1557 N12140929 SH1557 N10150211 SH1557 N10150320 SH1557 N10150528 SH1557 N10150616 SH1557 N10150721 SH1557 N10151209 SH1557 N10160307 SH1557 N10160519 SH1557 N10160509 SH1557 N10160728 SH1557 N10160907 SH1557 N10161031 SH1557 N11170111 SH1557 N11161216 SH1557 N11170427 SH1557 N10170504 SH1557 N10170…
UPC codes
00886874111611

Products covered by this recall

Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument Model/Catalog Number: 420194 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: NA

Check your product

The notice names 3 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00886874111611

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 420194

Model or item number

On the rating label, the box or the instruction sheet.

  • 420194 Software Version

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Intuitive Surgical, Inc. — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Intuitive Surgical, Inc. — 1266 Kifer Rd, Sunnyvale, CA, 94086-5304

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Intuitive Surgical, Inc. medical devices recalled?

Due to increased complaints for broken/frayed grip cables for reusable instruments. Due to increased complaints for broken/frayed grip cables for reusable instruments.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00886874111611; lot code 420194; model number 420194 Software Version. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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