The Recall Desk
HighFDA (Devices)·Z-1956-2015·Announced 2015-07-08

JustRight 5mm Stapler Reloads Recalled for Incomplete Staple Formation

Justright Surgical is recalling JustRight 5mm Stapler Reloads because they may deliver incomplete staple formation and incomplete tissue closure.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (incomplete tissue closure) in a surgical setting, but the source text does not report specific injuries or illnesses, fitting the criteria for a High severity score.

Plain-English summary

Justright Surgical, LLC is recalling various lots of JustRight 5mm Stapler Reloads (Model Number JR-REL25-2.0). The recall involves 1,452 units distributed in the United States and Ireland.

The recall is being issued because the products may deliver incomplete staple formation and incomplete tissue closure. The JustRight 5mm Stapler is intended for use in abdominal, gynecologic, pediatric, and thoracic surgery for the resection, transection, and creation of anastomosis.

The affected lot numbers are 75ED0114, 75JD1403, 75KD0304, 75KD0726, 75LD1224, 75AE0707, 75AE1406, 75BE1310, 75BE1313, 75CE2605, 75DE0802, and 75DE1524. Healthcare facilities should stop using these products and contact the manufacturer for instructions.

The recalled product

Product
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 cr
Manufacturer
Justright Surgical, LLC
Category
Medical Device — Surgical Stapler
Hazard
Affected units
1,452

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Justright Surgical, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Justright Surgical, LLC

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Same hazard · incomplete staple formation

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