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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

da Vinci S and Si Surgical Instruments Recalled for Broken Grip Cables

Agency Publication Date: March 30, 2026
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Summary

Intuitive Surgical, Inc. is recalling 99,753 reusable da Vinci S and Si surgical instruments, including scissors, graspers, needle drivers, and retractors, due to an increase in reports of broken or frayed grip cables. These mechanical tungsten cables are responsible for moving the instrument's jaws during surgery; if they fail, the instrument may lose function or break during a procedure. This recall affects various models including Monopolar Curved Scissors, Double Fenestrated Graspers, Mega Needle Drivers, and Grasping Retractors manufactured in the United States and distributed worldwide.

Risk

A broken or frayed grip cable can cause the surgical instrument to become unresponsive or malfunction during a procedure, potentially leading to surgical delays, unintended tissue damage, or the need for additional medical intervention to retrieve broken components.

What You Should Do

  1. Identify if your facility possesses any of the affected da Vinci S or Si instruments by checking the Brand Name and Model Number on the device labeling.
  2. Check the specific Material Number and Batch/System Number on your instrument's proximal chassis or packaging against the extensive list of affected codes.
  3. See the Affected Products section below for the full list of affected codes.
  4. Stop using the recalled surgical instruments immediately.
  5. Contact the manufacturer, Intuitive Surgical, Inc., or your authorized distributor to arrange for the return, replacement, or correction of the affected devices.
  6. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional safety information or to report adverse events.

Your Remedy Options

📋Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: da Vinci S and Si Monopolar Curved Scissors Instrument
Model / REF:
420179
Lot Numbers (676):
M10101102 SH0935
M10101201 SH0935
M10101202 SH1279
M10101203 SH0059
M10101204 USG294
M10101206 USG294
M10101206 SH1378
M10101214 USG022
M10101214 SH0035
M10101214 SH0495
M10110104 SH1279
M10110111 SH1378
M10110112 USG294
M10110113 SH0075
M10110121 SG704
M10110121 SH1279
M10110124 SH0495
M10110126 USG721
M10110126 SH1391
M10110127 USG721
M10110127 SH1279
M10110127 SH2144
M10110202 USG294
M10110202 SH0495
M10110203 SH2144
M10110208 SG704
M10110210 SH1378
M10110216 SH1368
M10110216 USG294
M10110216 SH1391
M10110217 SH0495
M10110217 SH1279
M10110222 SH1279
M10110228 SH0547
M10110228 USG721
M10110228 USG022
M10110228 SH1378
M10110228 SH1279
M10110301 SH1279
M10110303 SH0495
M10110304 USG294
M10110304 SH0729
M10110304 SH0761
M10110307 USG294
M10110308 USG294
M10110308 SH0035
M10110308 SH0495
M10110308 SH1279
M10110311 USG294
M10110311 SH2144
GTIN:
00886874111505

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.

Product: da Vinci S, Si Double Fenestrated Grasper Instrument
Model / REF:
420189
Lot Numbers (66):
M10120911 SH1182
M10130103 SH1182
M10130116 SH1182
M10130124 SH1182
M10130422 SH1182
M10130731 SH1182
M10130918 SH1182
M10110112 SG704
M10110202 SG704
M10110318 SG704
M10111028 SG704
M20111221 SG704
M10120220 SG704
M10120419 SG704
M10130110 SG704
M10130422 SG704
M10130726 SG704
M10130802 SG704
M10130802 SH0547
M10130918 SH0547
M10110808 SH0059
M10111027 SH0059
M10111104 SH0059
M10121123 SH0059
M10121213 SH0059
M10130103 SH0059
M10130815 SH1557
M10130625 SH1390
M10130731 SH1390
M10130802 SH1390
M10130603 USG721
M10120911 SH0825
M10120727 SH1378
M10121026 SH1378
M10121105 SH1378
M10130121 SH1378
M10130207 SH1378
M10130218 SH1378
M10130322 SH1378
M10130315 SH1378
M10130422 SH1378
M10130603 SH1378
M10130625 SH1378
M10130726 SH1378
M10131010 SH1378
M10110309 SH0729
M10110415 SH0729
M10110621 SH0729
M10110812 SH0729
M10121009 SH0729
GTIN:
00886874111581

Double Fenestrated Grasper

Product: da Vinci S, Si Mega Needle Driver Instrument
Model / REF:
420194
Lot Numbers (171):
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
GTIN:
00886874111611

Mega Needle Driver

Product: da Vinci S, Si Grasping Retractor Instrument
Model / REF:
420278
Lot 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
GTIN:
00886874111772

Grasping Retractor

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98383
Status: Active
Manufacturer: Intuitive Surgical, Inc.
Sold By: Authorized Medical Device Distributors; Intuitive Surgical Direct Sales
Manufactured In: United States
Units Affected: 4 products (86904; 2370; 7819; 2660)
Distributed To: California, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Texas, Virginia, Wisconsin

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.