FDA Device recall Z-1891-2020
daVinci XI Sureform 60 Reload, 60 mm black 6-Row 4.6 mm, Ref: 48360T-08 , UDI: 00886874113851, Rx only, SterileEO - Product Usage: are inte…
- FDA Device
- Class II
- ongoing
- Published 2020-05-13
On 2020-05-13 the FDA classified a Class II recall of daVinci XI Sureform 60 Reload, 60 mm black 6-Row 4.6 mm, Ref: 48360T-08 , UDI: 00886874113851, Rx only, SterileEO - Product Usage: are inte… by Intuitive Surgical, citing the firm became aware of a manufacturing variation in which black and green reloads in select Stapler Reloads may not deploy individual adjacent staples, which could result in an….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1891-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-07-01 |
| Published | 2020-05-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Intuitive Surgical |
| Distribution | US |
Product
daVinci XI Sureform 60 Reload, 60 mm black 6-Row 4.6 mm, Ref: 48360T-08 , UDI: 00886874113851, Rx only, SterileEO - Product Usage: are intended to be used with da Vinci Surgical Systems for resection, transection, and, or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery.
Reason
The firm became aware of a manufacturing variation in which black and green reloads in select Stapler Reloads may not deploy individual adjacent staples, which could result in an incomplete staple line. Failure of a incomplete staple like could potentially lead to an air leak or an anastomotic leak which may require an additional procedural intervention.
Identifiers
| code_info | Lot numbers: T10180615; T10180924; T10181003; T11181003; T10181010; T10181016; T10181029; T10181107; T10181109; T10181113 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1891-2020%22
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