The Recall Desk
HighFDA (Devices)·Z-2691-2014·Announced 2014-10-01

Justright Surgical Recalls 5mm Reloads Due to Poor Staple Formation

Justright Surgical is recalling specific lots of JustRight 5mm Reloads because they may deliver poor distal staple formation past the end of the knife cut.

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 involves a medical device defect that poses a risk of harm during surgery, but the source text does not report any injuries or illnesses, fitting the criteria for a high-risk product where injury has not yet been reported.

Plain-English summary

Justright Surgical, LLC is recalling specific lots of JustRight 5mm Reload products. The recall involves 3 cases containing 36 units of the JustRight 5mm Reload, REFJR-REL25-2.0, which are sterile, ethylene oxide sterilized, and prescription-only replacement cartridges used when more than one firing is required during a surgery.

The products are being recalled because they may deliver poor distal staple formation, past the end of the knife cut. The affected lot number is 75FD0417.

The recalled products were distributed in the states of Colorado, California, and New York. Healthcare providers and patients should stop using the affected products and contact Justright Surgical for further instructions.

The recalled product

Product
Justright Surgical, JustRight 5mm Reload, REFJR-REL25-2.0, Sterile, EO, Rx Only It is a replacement cartridge used when more than one firing is required during a surgery.
Manufacturer
Justright Surgical, LLC
Category
Medical Device — Surgical Stapler
Hazard

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 (1)

  • Lot: 75FD0417

Distribution

Distributed in 3 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

See all →