Intuitive Surgical, Inc. recalls Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description:…
Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic…
Read the official notice →- Date
- 2026-06-10
- Country
- United States
- Brand
- Intuitive Surgical
- Product
- Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description:…
- Classification
- Class II
- Units
- U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Intuitive Surgical recalls
- 2026-07-22
USIntuitive Surgical, Inc. recalls da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of instrument arm, which may result…
FDA · DeviceIntuitive Surgical, Inc.Worldwide - US Nationwide distribution in the states of NJ, OR, NY, FL, AL,…Official notice →- 2026-07-01
- US
Intuitive Surgical, Inc. recalls Da Vinci ASSY, PSS, SP1098, Part Number: 380601
Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled…
FDA · DeviceIntuitive Surgical, Inc.Worldwide - US Nationwide distribution including in the states of CA, GA, OH,…Official notice → - 2026-05-13
- US
Intuitive Surgical, Inc. recalls Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software…
Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.
FDA · DeviceIntuitive Surgical, Inc.Worldwide - U.S. Nationwide distribution including in the states of AK, AL,…Official notice → - US
Intuitive Surgical, Inc. recalls Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
FDA · DeviceIntuitive Surgical, Inc.US: Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware…Official notice → - 2026-04-08
- US
Intuitive Surgical, Inc. recalls Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instrument…
Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
FDA · DeviceIntuitive Surgical, Inc.U.S. Nationwide distribution in the states of AR, CA, CT, FL, IA, IL, IN, KS,…Official notice → - US
Intuitive Surgical, Inc. recalls Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument Model/Catalog…
Due to increased complaints for broken/frayed grip cables for reusable instruments.
FDA · DeviceIntuitive Surgical, Inc.Worldwide - U.S. Nationwide distribution in the states of CA, FL, GA, IA, IL,…Official notice →
Other drugs & medical recalls in the United States
- 2026-06-17
- US
Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules…
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- US
Fresenius Kabi USA, LLC recalls Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC…
Failed Impurities/Degradations Specifications
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, Manufactured for:…
Presence of Particulate matter: Particulate matter identified as glass.
- 2026-06-10
- US
SSC- Surgical Specialties Corporation recalls Sharpoint 2.2MM, ANGLED, DOUBLE- BEVEL Model/Catalog Number: 72-2231 Microsurgical Knife
3.0mm surgical knives labeled and packaged as 2.2mm surgical knives.
FDA · DeviceSSC- Surgical Specialties CorporationWorldwide - US Nationwide distribution in the states of Texas, Utah, Michigan…Official notice → - US
Grace Medical, Inc. recalls TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis
Due to incorrect functional length on device labeling.
- US
Windstone Medical Packaging, Inc. recalls Aligned Medical AMS16835 Fluids Kit RX
Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits.
FDA · DeviceWindstone Medical Packaging, Inc.US Nationwide distribution in the states of IL, VA.Official notice →