Ethicon Endo-Surgery Recalls Straight Intraluminal Staplers Due to Firing Defect
Ethicon Endo-Surgery is recalling 434,614 Straight Intraluminal Staplers (Model SDH33A) because they may have an insufficient firing stroke to break the washer and completely form staples.
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 I, which indicates a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls must be scored at least 4.
Plain-English summary
Ethicon Endo-Surgery Inc is recalling 434,614 units of Straight Intraluminal Staplers, 33 mm diameter, Model SDH33A. The recall covers all lots with expiration dates ranging from February 2023 to March 2024. These anastomotic staplers are used to permit tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.
The recall was initiated because the staplers may have an insufficient firing stroke to break the washer and completely form staples. This defect could compromise the integrity of the surgical anastomosis.
The affected products were distributed worldwide, including nationwide in the United States and in numerous other countries such as Argentina, Canada, China, India, Japan, and Mexico. Healthcare providers and facilities should stop using these devices and contact Ethicon Endo-Surgery for further instructions on return or replacement.
The recalled product
- Product
- Straight Intraluminal Staplers, 33 mm diameter, Model SDH33A 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
- Manufacturer
- Ethicon Endo-Surgery Inc
- Affected units
- 434,614
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)
- All Lots within EXPIRATION Date Range: February 2023 March 2024
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Ethicon Endo-Surgery Inc 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 · Ethicon Endo-Surgery Inc
See all →- HighLinear cutter reloads recalled after devices were shipped unsterilized
FDA (Devices) · 2025-10-22
- CriticalEndopath Echelon Vascular White Reload surgical stapler device lockout
FDA (Devices) · 2025-05-28
- HighEndoscopic Surgical Stapler Reload May Fail to Form Complete Staple Line
FDA (Devices) · 2024-02-07
- HighSurgical Shears HARMONICHD 1000i Recalled Due to Component Defect and Burn Risk
FDA (Devices) · 2021-09-01
- HighHARMONIC HD 1000i Surgical Shears Recalled for Potential Burn Risk
FDA (Devices) · 2021-09-01
Same hazard · surgical complication
See all →- HighSurgify Halo Surgical Burr May Break During Spinal Surgery
FDA (Devices) · 2026-07-01
- HighSurgify Halo surgical burrs recalled for potential breakage risk
FDA (Devices) · 2026-07-01
- HighSurgify Halo surgical burrs recalled for potential breakage during spinal surgery
FDA (Devices) · 2026-07-01
- HighSurgify Halo Surgical Burr Breakage Risk During Spinal Surgery
FDA (Devices) · 2026-07-01
- HighSurgify Halo surgical burrs recalled for potential breakage
FDA (Devices) · 2026-07-01