Recall of Covidien Endo GIA Ultra Universal Staplers Due to Sterility Risk
COVIDIEN LLC is recalling 2,180 units of Endo GIA Ultra Universal Staplers because the sterile barrier may be compromised, increasing the risk of infection.
What this means for you
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 involves a risk of infection from a compromised sterile barrier, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
COVIDIEN LLC is recalling 2,180 units of the Endo GIA Ultra Universal Stapler 12 mm (Item Code: EGIAUSTND). This medical device is intended for resection and transection in general surgery. The recall affects Lot Number P9E0022Y.
The recall is being issued because there is a potential for the sterile barrier of the product to be compromised. Products with a compromised sterile barrier may result in a potentially increased risk for infection.
The affected units were distributed in the United States, Israel, and Japan. Healthcare providers and facilities should stop using the affected lot and contact the manufacturer for further instructions.
The recalled product
- Product
- Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND
- Manufacturer
- COVIDIEN LLC
- Hazard
- Affected units
- 2,180
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)
- Lot Number: P9E0022Y
Distribution
Distributed nationwide across the United States.
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 · infection
See all →- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- HighSurgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
- HighV-Loc 180 Absorbable Wound Closure Device Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
- HighV-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19