FDAFDA · Food and drugs·Recall number Z-1276-2019
Straight Intraluminal Staplers, 25 mm diameter, Model SDH25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.
Published May 22, 2019 · Recall initiated: April 11, 2019
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ethicon Endo-Surgery Inc
- Distributor
- Worldwide Distribution: US (nationwide) and countries of: Argentina, Aruba, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Ecuador, Egypt, El Salvador, Guatemala, Honduras, India, Indonesia, Israel, Jamaica, Japan, Jordan, Korea, Kuwait, Lebanon, Malaysia, Maldives, Mexico, Nepal. Nicaragua, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Qatar, Saudi Arabia, Singapore, Sri Lanka, Taiwan, Thailand, UAE, Uruguay, Vietnam, and Yemen.
- Lot
- All Lots within EXPIRATION Date Range: February 2023 March 2024
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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