Patient Cart — Class II medical device recall Z-1518-2024

Ongoing recall by Intuitive Surgical, Inc., reported 2024-04-17, distributed in AL, CA, CO, FL, KS, KY, MD, MS…. Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry guide manipula

Recall number	`Z-1518-2024`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Intuitive Surgical, Inc., Sunnyvale, CA, United States
Recall initiated	2024-03-13
Classified	2024-04-11
Reported by FDA	2024-04-17
Distributed	AL, CA, CO, FL, KS, KY, MD, MS, NC, NH, NJ, NY, OH, SC, SD, TN, TX, VA, WA, WI, WV
Countries outside the US	CN, FR, JP, KR
Quantity	53
UPC / GTIN / UDI-DI	`00886874114605`
Serial numbers	`SP0202`, `SP0208`, `SP0219`, `SP0221`, `SP0223`, `SP0225`, `SP0226`, `SP0228`, `SP0229`, `SP0230`, `SP0231`, `SP0232`, `SP0233`, `SP0235`, `SP0236`, `SP0237`, `SP0238`, `SP0239`, `SP0240`, `SP0241`, `SP0242`, `SP0243`, `SP0244`, `SP0245`, `SP0247` and 28 more
Model numbers	`380601`, `SP1098`

Product

Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098

Reason for recall

Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry guide manipulator assembly/instrument arm joints, that may cause the following, 1) Top Failure: internal tissue injuries, body wall injury or emergent conversion to open surgery, 2) Bottom failure: pinching injury to the user with no harm to the patient.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1518-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.