CLASS II Device recall · Reported 1 Oct 2014 · FDA Enforcement Report

JustRight Stapler recalled by Justright Surgical

Justright Surgical is recalling Justright Surgical, JustRight Stapler, distributed in California, Colorado, New York. The recall was initiated on 27 Aug 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot: 75DD0406

Quantity recalled3 cases containing 18 units

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-2690-2014
FDA event ID: 69140
Recalling firm: Justright Surgical, Boulder, CO
Classification: Class II
Status: Terminated
Recall initiated: 27 Aug 2014
FDA classified: 23 Sep 2014
Reported: 1 Oct 2014
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Sterility
Device type: Surgical Instruments

Timeline

27 Aug 2014	Recall initiated by company
23 Sep 2014	Classified by FDA	+27 days
1 Oct 2014	Published in enforcement report	+8 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 specific lots of JustRight 5mm Stapler and Reload products because they may deliver poor distal staple formation, past the end of the knife cut.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Justright Surgical, JustRight 5mm Stapler, REF JR-ST25-2.0, Sterile, EO, Rx Only, JR-ST25-2.0 product is packaged in cases of 6. The JustRight 5mm Stapler is intended for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomosis.

Where it was distributed

Distributed in the states of Colorado, California and New York.

California Colorado New York

Questions about this recall

Is JustRight Stapler recalled?

Yes. Justright Surgical recalled JustRight Stapler on 27 Aug 2014. The recall is Class II and its status is Terminated. Recall number Z-2690-2014.

Why was it recalled?

JustRight Surgical is recalling specific lots of JustRight 5mm Stapler and Reload products because they may deliver poor distal staple formation, past the end of the knife cut.

Which lots are affected?

Lot: 75DD0406

Where was it sold?

Distributed in the states of Colorado, California and New York.

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
8 Jul 2015Device	CLASS II	JustRight Reload, JR-REL25-2.0 Reload is recalled by Justright Surgical	Justright Surgical	Packaging Defects	Nationwide
1 Oct 2014Device	CLASS II	JustRight Reload, Refjr-REL25-2.0, Sterile, EO recalled	Justright Surgical	Sterility	CA, CO, NY

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Sterility	Nationwide