Z-1891-2020Class II

daVinci XI Sureform 60 Reload, 60 mm black 6-Row 4.6 mm, Ref: 48360T-08 , UDI: 00886874113851, Rx only...

Name: Z-1891-2020 daVinci XI Sureform 60 Reload, 60 mm black 6-Row 4.6 mm, Ref: 48360T-08 , UDI: 00886874113851, Rx only...
Creator: Intuitive Surgical, Inc.
Published: 2019-07-01
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2019-07-01 / Open, Classified / root cause: manufacturing process

FDA source

Intuitive Surgical, Inc. began a 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 intended to be used with... on 2019-07-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1891-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-07-01
Posted: 2020-05-05
Recalling firm: Intuitive Surgical, Inc.
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.
Product code: GAG Stapler, Surgical
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On July 1, 2019 , the firm sent an "Urgent Medical Device Recall" notification to affected customers concer the da Vinci Xi SureForm 60 Stapler Reload. In addition to informing customer's about the recalled product, the firm asked customers to take the following actions: 1. Intuitive Surgical requests customers locate the affected Stapler Reloads at each site and return them. 2. Inform necessary personnel when corrective action has been completed. 3. If customer has distributed any affected product to other sites, please forward this notice to all related parties. 4. If available, please log into the da Vinci Online Community Field Action resource to read or complete any requested actions related to this issue, at this link: https://www.davincisurgerycommunity.com/ 5. Complete the attached Acknowledgement Form and return it via fax to Intuitive Surgical as instructed on the form, or complete using the da Vinci online resource tool.
Distribution: Worldwide distribution - US Nationwide including in the states of AL, AK, AZ, AR, CA, CO, CT, DE, D.C., FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI and the countries of Australia, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Luxembourg, Netherlands, Norway, South Korea, Spain, Switzerland, United Kingdom.
Product codes and lots: Lot numbers: T10180615; T10180924; T10181003; T11181003; T10181010; T10181016; T10181029; T10181107; T10181109; T10181113

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1891-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1890-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-05-13	2020-05-05
Z-1891-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-05-13	2020-05-05

Product code GAG

K173721Class IISureForm 60 and SureForm 60 ReloadsIntuitive Surgical / cleared 2018-07-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)