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Ethicon Endo-Surgery Inc FDA Recalls
6 recalls on file across devices, 1 of them Class I and 5 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product NClass IISep 11, 2025The devices were shipped unsterilized. |
| Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35Class IApr 22, 2025Firm has received an increase in reports regarding inadverte |
| ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear CutteClass IIDec 11, 2023There is the potential for incomplete staple line formation |
| HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermClass IIJul 20, 2021An internal component may be cracked and become lodged behin |
| HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermaClass IIJul 20, 2021An internal component may be cracked and become lodged behin |
| ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments hClass IIJun 3, 2021Mislabeled: Labeled on the package as 60mm contains 45mm de |