FDA Medical devices recall · April 8, 2026

da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S… recall

Read the official FDA notice ↗

Product

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

Why was it recalled?

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

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

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

Distribution

Worldwide - U.S. Nationwide distribution in the states of CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MO, MS, NC, NJ, NY, OH, PA, TX, VA and WI. The countries of Argentina, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Ecuador, France, Germany, Greece, Guadeloupe, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Pakistan, Philippines, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, South Korea, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.

States: California Florida Georgia Iowa Illinois Indiana Kansas Kentucky Louisiana Massachusetts Missouri Mississippi North Carolina New Jersey New York Ohio Pennsylvania Texas Virginia Wisconsin

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-1699-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.