Recall of Signia Tri-Staple 2.0 Reloads Due to Missing Pin Components
Covidien LLC is recalling Signia Tri-Staple 2.0 reloads because missing pin components may cause incomplete staple formation, leading to serious surgical complications.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 involves a defect that can lead to serious medical conditions such as sepsis, peritonitis, and pneumothorax, meeting the criteria for a Severe rating.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Signia Tri-Staple 2.0 Black 45mm Extra Thick Reloads (SIG45AXT) manufactured by Covidien LLC. The recall involves 3,113,280 units that were distributed nationwide and worldwide.
The recall is due to a defect where the device may be missing one of two pin components that maintain the alignment of the device jaws. This defect can result in incomplete staple formation during use. Incomplete staple formation may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax, which can result in the potential for infection and/or sepsis.
Healthcare providers and facilities should stop using the affected devices and contact the recalling firm for instructions on return or replacement. The specific lot codes affected are listed in the agency's recall record.
The recalled product
- Product
- SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
- Manufacturer
- Covidien LLC
- Affected units
- 3,113,280
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Covidien 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 12 products in this recall →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
- ModerateCovidien 9 Fr Mon-a-Therm temperature probes lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateCovidien esophageal stethoscope temperature sensors lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateShiley tracheostomy tubes recalled over incorrect display box labeling
FDA (Devices) · 2026-06-10
Same hazard · incomplete staple formation
See all →- SevereFDA Recalls Covidien TA Auto Suture Vascular Loading Units
FDA (Devices) · 2021-01-06
- SevereFDA Recalls Covidien TA Auto Suture Vascular Staplers Due to Damaged Components
FDA (Devices) · 2021-01-06
- HighEndo GIA Auto Suture Universal Loading Unit Recall for Staple Formation Defect
FDA (Devices) · 2020-10-07
- HighRecall of Covidien Endo GIA Universal Loading Units Due to Staple Formation Defect
FDA (Devices) · 2020-10-07
- SevereFDA Recalls Endo GIA Auto Suture Units Due to Staple Formation Defects
FDA (Devices) · 2020-10-07
Similar recalls
- HighTri-Staple 2.0 surgical stapler cartridge damage may cause incomplete stapling
FDA (Devices) · 2024-06-05
- HighTri-Staple 2.0 Surgical Stapler Reloads Recalled for Malfunction Risk
FDA (Devices) · 2023-03-15
- HighCovidien Signia Surgical Stapler Reloads Recalled Due to Articulation Defect
FDA (Devices) · 2024-04-10
- HighFDA Recalls 222 Units of Covidien Tri-Staple 2.0 Reinforced Intelligent Reloads
FDA (Devices) · 2021-04-21
- SevereFDA Recalls Covidien Signia Stapler Reloads Due to Safety Interlock Failure
FDA (Devices) · 2021-04-21
- HighMedtronic Tri-Staple 2.0 Reloads Recalled for Missing Sled Component
FDA (Devices) · 2018-07-25