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FDA Medical Device Recalls (openFDA)

Intuitive Surgical, Inc.: Intuiitve Surgical da Vinci 8 mm EndoWrist Curved Scissors, in box. All lots. P/N 400178-01

Recall number
Z-0723-05
Recalling firm
Intuitive Surgical, Inc.
Product
Intuiitve Surgical da Vinci 8 mm EndoWrist Curved Scissors, in box. All lots. P/N 400178-01
Status
Terminated
Initiated
2005-03-09
Posted
2005-04-22
Terminated
2005-05-13
Reason
Blades on the scissor may break and separate from the main unit as a result of corrosion damage.
Root cause
Other
Action
The firm has sent notification letters to its consignees on 03/09/2005. Consignees are requested to return the feedback form provided by Intuitive Surgical, via Federal Express.
Quantity
278 units have been distributed.
Distribution
The product was distributed to 84 medical facilities, located throughout the US and Switzerland, Belgium, Germany, Australia, Turkey and France.
Lot, serial or model codes
FDA Device Listing Number R100529, Model Number 400178-01. 510(k) number K021036.
510(k) numbers
["K021036"]
PMA numbers
not on file
Product code
LRW
Firm FEI
3001675293
Firm city
Sunnyvale
Firm state
CA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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