Notice names this product. Intuitive Surgical’s da Vinci SP Instrument Arm Drape is named in FDA Class II recall Z-2722-2026.
Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies.Agency-reported hazard: 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 in procedure delay or conversion to an alternate minimally invasive approach. Retrospectively reported recall. Identifying details: UDI-DI: 00886874113486, Lot: 3074LA0500, 1124LA0200, 2124LA0400, 1134LA0700, 1144LA0500, 7154LA0200, 6164LA0800, 1084LA0300, 3164LAA800, 4084LA0500, 4124LA0600, 1274LA0500, 2294LA0200, 1274LA0400, 4284LA0800, 6324LA0200, 1324LA0300, 4154LA0400, 2284LA0100, 4144LA1300, 3324LA0500, 2354LA0500, 7144LA0500, 4294LA0700, 3374LA0400, 5264LA0700, 3224LA0500, 3424LA0200, 1394LA0100. Units affected: 11,113. Status: Ongoing.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Worldwide - US Nationwide distribution in the states of NJ, OR, NY, FL, AL, SD, TX, VA, WV, PA, CA, WA, CT, MA, IL, OK, OH, MI, NC, MO, KY, WI, AZ, CO, GA, MD, SC, IN, NV, TN, MS, KS, IA, UT, MN, LA, NE, ME and the countries of Germany, Sweden, United Kingdom, Italy, Belgium, Switzerland, Denmark, Japan, South Korea, Hong Kong, Taiwan, France, Ireland, Spain.
Agency product description and boundaries
da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
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 secti…