FDA Recalls 163 Endo GIA Radial Reloads Due to Manufacturing Error
The FDA is recalling 163 Endo GIA Radial Reloads with Tri-Staple Technology because the device cartridge disengaged during use due to a manufacturing error.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the device disengaged during use, which poses a significant risk of injury to patients during surgery.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 163 units of Endo GIA Radial Reloads with Tri-Staple Technology manufactured by Covidien LLC. The recall is due to a manufacturing error that caused the device cartridge to disengage during use.
These medical devices are intended for use in open or minimally invasive general abdominal, gynecologic, and thoracic surgery for the resection and transection of tissue and creation of anastomosis. They are also used for transection and resection of liver substance, hepatic vasculature, biliary structures, and the pancreas.
The affected units are identified by product number EGIARADXT and lot code N6L0351X. The distribution pattern indicates that the devices were distributed internationally, including in Japan, but there were no USA customers. Healthcare providers and facilities should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- Product
- Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have application in open or minimally invasive general abdominal, gynecologic and thoracic surgery for resection and transection of tissue and creation of anastomosis,
- Manufacturer
- Covidien LLC
- Affected units
- 163
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)
- Product number: EGIARADXT Lot code: N6L0351X
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Covidien LLC
See all →- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- ModerateCovidien Shiley Disposable Decannulation Plug product labeling error
FDA (Devices) · 2026-07-08
- ModerateShiley tracheostomy tubes recalled over incorrect display box labeling
FDA (Devices) · 2026-06-10
- ModerateCovidien Mon-a-Therm general purpose temperature probes lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateCovidien esophageal stethoscope temperature sensors lack FDA clearance
FDA (Devices) · 2026-06-10
Same hazard · device failure
See all →- SevereMedline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Damage Risk
FDA (Devices) · 2026-09-02
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighCOAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling
FDA (Devices) · 2026-08-12
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighCOAPTIUM Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12