FDA Device recall Z-0924-2025
8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedur…
- FDA Device
- Class II
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class II recall of 8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedur… by Intuitive Surgical, citing due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0924-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-12-19 |
| Published | 2025-01-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Intuitive Surgical |
| Distribution | US |
Product
8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction of tissue.
Reason
Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
Identifiers
| code_info | Product Number: 470318 UDI-Di code: 00886874112441 Part Number and Version: 470318-04 Lot Numbers: S10131209 S10131210…Product Number: 470318 UDI-Di code: 00886874112441 Part Number and Version: 470318-04 Lot Numbers: S10131209 S10131210 Part Number and Version: 470318-07 Lot Numbers: S10140617 S10140618 S10140619 S10140620 S10140717 S10140801 S10140812 S10140821 S10140823 S10140915 S10141008 S10141120 S10141205 S10141219 S10150108 S10150120 S10150122 S10150206 S10150212 S11140620 Part Number and Version: 470318-08 Lot Numbers: N10151230 N10160104 N10160113 N10160203 N10160218 N10160219 N10160307 N10160317 N10160330 N10160404 N10160406 N10160420 N10160426 N10160525 N10160607 N10160616 N10160725 N10160726 N10160802 N10160810 N10160824 N10160901 N10160914 N10160927 N10161010 N10161020 N10161102 N10161111 N10161128 N10161209 N10170119 N10170203 N10170222 N10170309 N10170330 N10170419 N10170502 N10170512 N10170518 N10170612 N10170623 N10170703 N10170725 N10170728 N10170801 N10170802 N10170822 N10170823 N10170906 N10170914 N10171012 N10171101 N10171115 N10171124 N10171206 N10171219 N10171227 N10180122 N1 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0924-2025%22
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