Intuitive Surgical, Inc. recalls INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Gray…
Potential staple deployment failure and device fragment generation
Read the official notice →- Date
- 2022-12-07
- Country
- United States
- Brand
- Intuitive Surgical
- Product
- INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Gray…
- Classification
- Class II
- Units
- U.S.: Arizona, California, Colorado, Florida, Illinois, Indiana, Louisiana,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2023-07-12
USIntuitive Surgical, Inc. recalls da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12
Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragments falling into the patient that may be either detected…
FDA · DeviceIntuitive Surgical, Inc.Worldwide - US Nationwide distribution in the states of PR, FL, MN, PA, AZ,…Official notice →- 2023-04-05
- US
Intuitive Surgical, Inc. recalls da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200
Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specifications.
FDA · DeviceIntuitive Surgical, Inc.U.S.: Cayman Islands, Dominican Republic, Puerto Rico, United States O.U.S.:…Official notice → - 2023-03-22
- US
Intuitive Surgical, Inc. recalls Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; Patient Side Cart,…
Preventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow surgeons to perform surgical tasks, that may be at risk of insertion ballscrew failure, allowing for uncontrolled…
FDA · DeviceIntuitive Surgical, Inc.Worldwide - US Nationwide distribution in the states of FL, GA, WA and the…Official notice → - 2022-11-02
- US
Intuitive Surgical, Inc. recalls da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSCART), Vision…
Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments installed on system 2) Force bipolar connected to Force Triad generator, bipolar not connected to generator 3)…
FDA · DeviceIntuitive Surgical, Inc.US: MS, PA, WI, KY, TN, MI, FL, GA, NC, NV, LA, OH, IL, MO, IN, CA, AK, MD,…Official notice → - 2022-08-10
- US
Intuitive Surgical, Inc. recalls The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to be used with the da Vinci Xi and X systems. The…
Due to preventative maintenance (PM) not being performed on E-100 generators which is a bipolar electrosugical unit designed to be used with the da Vinci Xi and X systems.
FDA · DeviceIntuitive Surgical, Inc.Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK,…Official notice → - 2022-08-03
- US
Intuitive Surgical, Inc. recalls Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 420327 Da Vinci S/Si Small Clip Applier,…
Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.
FDA · DeviceIntuitive Surgical, Inc.Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK,…Official notice →
Other drugs & medical recalls in the United States
- 2022-12-07
- US
Owens & Minor Distribution, Inc. recalls Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734
Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection
- US
Bio-Rad Laboratories, Inc. recalls CMV IgM EIA, in vitro diagnostic.
Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).
FDA · DeviceBio-Rad Laboratories, Inc.U.S.: CA, CO, FL, GA, HI, IA, MA, MN, NC, NH, NJ, PA, TN, and TX O.U.S.: NoneOfficial notice → - US
Cytocell Ltd. recalls CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782
An error with the chromomap on version 1 of the package insert which is incorrect. The nucleotide locations specified in the insert are correct but the map has been created using the wrong coordinates.
- US
Busse Hospital Disposables, Inc. recalls Busse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1
Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable
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GS Biomark LLC recalls CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200; BM-AD4K0200 BM-ADK0200 BM-CDK0200 BM-CFDK0200 BM-D4K0200…
Distribution of COVID Test Kits without FDA Approval, Clearance or Authorization.
FDA · DeviceGS Biomark LLCU.S.: TX, NY, GA, IN, MD, CA, PA, MD, DC, NJ, OR, WA O.U.S.: NoneOfficial notice → - US
Acella Pharmaceuticals, LLC recalls Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, Net weight 3.7g (60 cleansing pads Net weight 3.7 g each per carton,) Rx Only,…
Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.