Reported Dec 7, 2022 · Ongoing
INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30…
Intuitive Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intuitive Surgical, Inc. · 1266 Kifer Rd Bldg 101 · Sunnyvale, CA · 94086-5304
Is this the product you have?
4 of 4 products
| Model / number | Product as published |
|---|---|
488530 | INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Gray 4-Row 2.0 mm Xi|X |
48230M | INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm White 4-Row 2.5 mm Xi|X |
48230W | INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Blue 4-Row 3.5 mm Xi|X |
48230B | — |
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Barcodes Product as published 488530-1010886874121723Da Vinci Xi 8mm SureForm 30 Grey Reload 48230M-0210886874121938Da Vinci Xi 8mm SureForm 30 White Reload 48230W-0210886874121921Da Vinci Xi 8mm SureForm 30 Blue Reload 48230B-0210886874121914All Serial Numbers - Amount recalled
- 160 boxes of 488530-10 = 960 individual instruments 602 reload boxes = 7224 individual reloads
Where it was sold
Why it was recalled
Potential staple deployment failure and device fragment generation
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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