United StatesIntuitive 8 mm SureForm 30 Gray Reloads (reference numbers 48230M-05 and 48230M-06; UDI 00886874121931 / all serial numbers) are affected. They were recalled because the reloads for the curved‑tipped stapler may potentially produce an incomplete staple line. The product was distributed in the United States and multiple other countries listed by the firm.
What's being recalled
Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
Recalling firm: Intuitive Surgical, Inc., Sunnyvale, CA, United States.
How to identify it
UDI:00886874121931/All serial Numbers
The hazard
Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US: Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware District of Columbia Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin OUS: Austria Belgium Denmark Finland France Germany Ireland Italy Japan Netherlands Norway Spain Sweden Switzerland United Kingdom
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)