Covidien EGIA 45 Articulating Medical Stapler Recall for Missing Pins
FDA is recalling 3.1 million EGIA 45 staplers due to missing pins that may cause incomplete stapling and serious surgical complications.
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 involves a defect that can lead to serious medical complications such as sepsis, peritonitis, and pneumothorax, meeting the criteria for a Severe rating.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling 3,113,280 units of the EGIA 45 Articulating Med Thick Sulu (Item Code EGIA45AMT) manufactured by Covidien LLC. The recall is classified as Class II. The affected devices were distributed nationwide in the United States and internationally.
The recall was initiated because the device may be missing one of two pin components that maintain alignment of the device jaws. This defect can result in incomplete staple formation during use. Incomplete stapling 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 check their inventory for the specific lot numbers listed in the recall notice. If the device is found, it should be removed from service and returned to the manufacturer or disposed of according to the recall instructions provided by the firm.
The recalled product
- Product
- EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
- 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
- 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 · incomplete stapling
See all →- HighEndoscopic Surgical Stapler Reload May Fail to Form Complete Staple Line
FDA (Devices) · 2024-02-07
- SevereFDA Recalls Covidien EGIA 60 Articulating Extra Thick Sulu Devices
FDA (Devices) · 2019-06-26
- SevereEthicon Endo-Surgery Recalls Endoscopic Curved Intraluminal Staplers
FDA (Devices) · 2019-05-22
- SevereEthicon Endo-Surgery Recalls Straight Intraluminal Staplers Due to Firing Defect
FDA (Devices) · 2019-05-22