Class II U.S. Food and Drug Administration

Intuitive Surgical, Inc. Brand Name: da Vinci S, Si Grasping Retractor 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-1699-2026
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
2660
Distribution
Nationwide
Made in
United States
Lot / code info
Lot Code: 420278: Grasping Retractor GTIN: 00886874111772 FDA Medical Device Listing Number: D088920 Material Number: 420278-04 Batch / System Numbers: M10110613 SH1182 M10120127 SH1182 M10120217 SH1182 M10120829 SH1182 M10130103 SH1182 M10130114 SH1182 M11130404 SH1182 M10130527 SH1182 M10130606 SH1182 M10130909 SH1182 M10130925 SH1182 S10101229 SG704 S10110105 SG704 M10121214 SH0547 M10110118 SH0059 M10110613 SH0059 S10110819 SH0059 M10121122 SH0059 M10121214 SH0059 M10130114 SH0059 M10130220 SH0059 M10130319 SH0059 M11130404 SH0059 M10120912 SH1390 M10130730 USG721 M10130909 USG721 M10110307 SH0729 M10130214 SH0729 M11130404 SH0729 M10130617 SH0729 M10130628 SH0729 M10120127 SH1076 M10130307 SH1279 M10111028 SH0761 Material Number: 420278-06 Batch / System Numbers: M10140115 SH1182 N10140725 SH1182 N10140923 SH1182 N10150324 SH1182 N10150417 SH1182 N10150721 SH1182 N10150608 SH1182 N10150820 SH1182 N10151113 SH1182 N10151214 SH1182 N10151029 SH1182 N10160304 SH1182 N10151201 SH1182 N10141205 SH1182 N10160921 SH1182 N10161123 SH1182 N10170516 SH1182 N10170601 SH1182 N10170921 SH1182 N10171213 SH1182 N10171226 SH1182 N10180417 SH1182 N10140815 SG704 N10150210 SG704 N10150608 SG704 N10160203 SG704 N10170117 SG704 N10170921 SG704 N10170822 SG704 N10171002 SG704 N10171226 SG704 M10140306 SH0059 N10141205 SH0059 N10150605 SH0059 N10170213 SH0059 N10171213 SH0059 N10171117 SH1964 N10180417 SH1964 N10170310 USG294 M10140306 USG721 M10140319 USG721 N10170412 USG721 N10180117 USG721 N10150224 SH1378 N10160203 SH1378 M10140306 SH0729 N10140828 SH0729 N10150330 SH0729 N10150319 SH0729 N10150525 SH0729 N10151020 SH0729 N10160503 SH0729 N10160524 SH0729 N10180417 SH0729 N10141001 SH1076 N10141030 SH1076 N10151211 SH1604 N10160524 SH1604 N10160801 SH1604 N10160921 SH1604 N10171226 SH1604 N10160921 SH1385 N10161010 SH1385 N10161114 SH1385 N10171117 SH1385 Material Number: 420278-07 Batch / System Numbers: N10181219 SH1182 N10180906 SH1182 N10190423 SH1182 N10181114 SH1182 N10180906 SG704 N10180910 USG721 N10181114 SH1604 Material Number: 420278-09 Batch / System Numbers: N10190826 SH1182 N10190515 SH1182 N10190909 SH1182 N10190902 SH1964 N10190826 SH1964 N10190515 SH1964 N10190909 SH1964 N10190826 USG721 N10190902 SH1604
UPC codes
00886874111772

Products covered by this recall

Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping Retractor Instrument Model/Catalog Number: 420278 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.

  • 00886874111772

Lot or batch code

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

  • 420278

Model or item number

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

  • 420278 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. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

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 00886874111772; lot code 420278; model number 420278 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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