Official recall record
da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2025-05-12
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00886874113486
- Brand on record
- Intuitive Surgical, Inc.
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-09-16.
Record last checked against the registry on 2026-09-16.
Same barcode in other registries
The same EAN appears in 1 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2018-10-25 · US FDA — Medical Devices
da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch
Other recalls from this brand
- 2026-04-22 · US FDA — Medical Devices
Da Vinci ASSY, PSS, SP1098, Part Number: 380601 - 2025-12-30 · US FDA — Medical Devices
da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
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