JustRight 5mm Stapler Recalled for Incomplete Staple Formation
Justright Surgical is recalling JustRight 5mm Staplers because they may deliver incomplete staple formation and incomplete tissue closure.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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, and the hazard involves a risk-of-harm product (incomplete tissue closure) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Justright Surgical, LLC is recalling various lots of the JustRight 5mm Stapler, model number JR-ST25-2.0. The recall involves 822 units distributed nationwide in the United States and in Ireland. The affected staplers are packaged in cases of 6, placed in a tray, and sealed with a Tyvek lid.
The recall is being conducted because the devices 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 recall includes specific lot numbers: 75ED0116, 75JD1404, 75KD0308, 75KD1216, 75LD0508, 75AE0709, 75AE2601, 75BE0506, 75BE2315, 75CE1630, 75CE2606, 75DE0102, and 75DE0804 (UK distribution). Healthcare providers and facilities should check their inventory for these specific model and lot numbers.
The recalled product
- 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…
- Manufacturer
- Justright Surgical, LLC
- Affected units
- 822
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 (13)
- Model Number JR-ST25-2.0 Lot numbers 75ED0116
- 75JD1404
- 75KD0308
- 75KD1216
- 75LD0508
- 75AE0709
- 75AE2601
- 75BE0506
- 75BE2315
- 75CE1630
- 75CE2606
- 75DE0102
- and 75DE0804 (UK distribution).
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
See all →- HighJustRight 5mm Stapler Reloads Recalled for Incomplete Staple Formation
FDA (Devices) · 2015-07-08
- HighJustright Surgical Recalls 5mm Reloads Due to Poor Staple Formation
FDA (Devices) · 2014-10-01
- HighJustright Surgical Recalls 5mm Staplers Due to Poor Staple Formation
FDA (Devices) · 2014-10-01
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