CLASS II Device recall · Reported 8 Jul 2015 · FDA Enforcement Report

JustRight Reload, JR-REL25-2.0 Reload is recalled by Justright Surgical

Justright Surgical is recalling JustRight Reload, JR-REL25-2.0 Reload is, distributed nationwide in the US. The recall was initiated on 11 Jun 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number JR-REL25-2.0 Lot numbers 75ED0114, 75JD1403, 75KD0304, 75KD0726, 75LD1224, 75AE0707, 75AE1406, 75BE1310, 75BE1313, 75CE2605, 75DE0802, and 75DE1524.

Quantity recalled1452

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1956-2015
FDA event ID: 71521
Recalling firm: Justright Surgical, Boulder, CO
Classification: Class II
Status: Terminated
Recall initiated: 11 Jun 2015
FDA classified: 2 Jul 2015
Reported: 8 Jul 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Surgical Instruments

Timeline

11 Jun 2015	Recall initiated by company
2 Jul 2015	Classified by FDA	+21 days
8 Jul 2015	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

JustRight 5mm Reload, JR-REL25-2.0 Reload is packaged in cases of 12., 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.

Where it was distributed

Distribution - US Nationwide and Ireland.

Nationwide

Questions about this recall

Is JustRight Reload, JR-REL25-2.0 Reload is recalled?

Yes. Justright Surgical recalled JustRight Reload, JR-REL25-2.0 Reload is on 11 Jun 2015. The recall is Class II and its status is Terminated. Recall number Z-1956-2015.

Why was it recalled?

JustRight Surgical is recalling various lots of JustRight 5mm Stapler product because they may deliver incomplete staple formation and incomplete tissue closure.

Which lots are affected?

Model Number JR-REL25-2.0 Lot numbers 75ED0114, 75JD1403, 75KD0304, 75KD0726, 75LD1224, 75AE0707, 75AE1406, 75BE1310, 75BE1313, 75CE2605, 75DE0802, and 75DE1524.

Where was it sold?

Distribution - US Nationwide and Ireland.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Justright Surgical

All 4

Reported	Class	Recall	Company	Reason	Where
8 Jul 2015Device	CLASS II	JustRight Stapler, JR-ST25-2.0 Stapler is recalled by Justright Surgical	Justright Surgical	Packaging Defects	Nationwide
1 Oct 2014Device	CLASS II	JustRight Stapler recalled by Justright Surgical	Justright Surgical	Sterility	CA, CO, NY
1 Oct 2014Device	CLASS II	JustRight Reload, Refjr-REL25-2.0, Sterile, EO recalled	Justright Surgical	Sterility	CA, CO, NY

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