Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
FDA device recall Z-1855-2026 · posted 2026-05-01 · Open, Classified
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
- Action taken
- On 3/17/2026 Intuitive Surgical issued a "urgent Medical Device Recall Notification to affected consignees via E.Mail and FedEx. Intuitive ask consignees to take the following actions: 1. Please identify, discontinue use, and quarantine any affected product(s). Affected product(s) may be returned by calling customer service with quantities and lot numbers to your regional customer service. 2. Complete the attached Acknowledgement Form immediately and return it via fax or email to Intuitive as instructed on the form. 3. Please ensure to include the Recall or FSCA number ISIFA2026-02-R in your return notes. 4. If you have shared or further distributed these products with other sites, please make sure appropriate staff at the site receive and understand this notification so they locate and return their affected product.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- NAY
- Distribution
- US: Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware District of Columbia Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachuse
- Date initiated
- 2026-03-11
- Date posted
- 2026-05-01
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads (K241638) | Intuitive Surgical, Inc. | 2024-09-10 |
| EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System (K222839) | Intuitive Surgical, Inc. | 2023-03-16 |
| 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads (K211997) | Intuitive Surgical, Inc. | 2021-12-10 |