Z-1955-2015Class II

JustRight 5mm Stapler, JR-ST25-2.0 Stapler is packaged in cases of 6, placed in a tray and sealed with a...

Name: Z-1955-2015 JustRight 5mm Stapler, JR-ST25-2.0 Stapler is packaged in cases of 6, placed in a tray and sealed with a...
Creator: Justright Surgical, LLC
Published: 2015-06-11
License: https://open.fda.gov/license/

Bolder Surgical, LLC / initiated 2015-06-11 / Terminated / root cause: manufacturing process

FDA source

Justright Surgical, LLC began a recall of JustRight 5mm Stapler, JR-ST25-2.0 Stapler is packaged in cases of 6, placed in a tray and sealed with a Tyvek lid. Product Usage: The JustRight 5mm Stapler is... on 2015-06-11. FDA classified it as Class II and gives the reason as "JustRight Surgical is recalling various lots of JustRight 5mm Stapler product because they may deliver incomplete staple formation and incomplete tissue closure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1955-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-11
Posted: 2015-07-02
Terminated: 2015-08-26
Recalling firm: Bolder Surgical, LLC
Product: JustRight 5mm Stapler, JR-ST25-2.0 Stapler is packaged in cases of 6, placed in a tray and sealed with a Tyvek lid. Product Usage: The JustRight 5mm Stapler is intended for use in abdominal, gynecologic, pediatric, and thoracic surgery for the resection, transection, and creation of anastomosis.
Product code: GDW Staple, Implantable
Reason for recall: JustRight Surgical is recalling various lots of JustRight 5mm Stapler product because they may deliver incomplete staple formation and incomplete tissue closure.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: JustRight Surgical sent an Urgent Medical Device Recall letter dated June 12, 2015 to aaffected customers and distributor via an email. The letter identified the affected product, problem and actions to be taken. Custers were instructed Review, complete, and return the enclosed Acknowledgement Form directly to Rep, your Sales Representative or email to [email protected] or fax to (720) 287-7135. The following assistance is available: " For questions related to the issue or product replacement, please contact your local sales representative, Rep, or contact JustRight Surgical Customer Service at (866) 683-1743, Monday through Friday from 7:30 AM to 5:00 PM MST. " For questions related to product pick-up by JustRight Surgical, please also contact your local sales representative or Customer Service (866) 683-1743. Return instructions are provided on the Acknowledgement Form. " For questions related to the Acknowledgement Form and its return, please contact the JustRight Surgical Director of Quality Systems at (720) 287-7146.
Quantity in commerce: 822
Distribution: Distribution - US Nationwide and Ireland.
Product codes and lots: Model Number JR-ST25-2.0 Lot numbers 75ED0116, 75JD1404, 75KD0308, 75KD1216, 75LD0508, 75AE0709, 75AE2601, 75BE0506, 75BE2315, 75CE1630, 75CE2606, 75DE0102, and 75DE0804 (UK distribution).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1955-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1955-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-07-02
Z-1956-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-07-02

Product code GDW

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)