CLASS II ONGOING Device recall · Reported 7 Feb 2024 · FDA Enforcement Report
Endopath Echelon Reloads With Gripping Surface Technology recalled
Ethicon Endo-Surgery is recalling Endopath Echelon Reloads With Gripping Surface Technology (Gst), Echelon Endopath Stapler, distributed nationwide in the US. The recall was initiated on 11 Dec 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0834-2024
- FDA event ID
- 93735
- Recalling firm
- Ethicon Endo-Surgery, Blue Ash, OH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Dec 2023
- FDA classified
- 26 Jan 2024
- Reported
- 7 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 11 Dec 2023 | Recall initiated by company | |
| 26 Jan 2024 | Classified by FDA | +46 days |
| 7 Feb 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue apposition that could require surgical intervention. This may result in bleeding, prolonged surgery, or surgical delay.
Product as listed by the FDA
ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology), 45MM WHITE VASCULAR/THIN, Product No. GST45W
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada and Brazil.
Questions about this recall
Why was it recalled?
There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue apposition that could require surgical intervention. This may result in bleeding, prolonged surgery, or surgical delay.
Which lots are affected?
UDI-DI 10705036014928 Lots 442C02 and 442C03
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada and Brazil.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ethicon Endo-Surgery
All 58| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Echelon Linear Cutters Reload Blue, intended recalled | Ethicon Endo-Surgery | Other | OH |
| Device | CLASS I | Endopath Echelon Vascular White Reload recalled by Ethicon Endo-Surgery | Ethicon Endo-Surgery | Other | Nationwide |
| Device | CLASS II | Pdsii¿vio¿¿usp6-0(m0.7)¿d/a¿c recalled by Ethicon Endo Surgery | Ethicon Endo Surgery | Other | Nationwide |
| Device | CLASS II | Ethibond Excel Grn Usp2-0(m3) D/a Mh recalled by Ethicon Endo Surgery | Ethicon Endo Surgery | Other | Nationwide |
| Device | CLASS II | Prolene Blu Usp6-0(m0.7) S/a P-1 Prm recalled by Ethicon Endo Surgery | Ethicon Endo Surgery | Other | Nationwide |
Other Heart & Vascular Devices recalls
All 6,220| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | TufTex¿ Over-the-Wire Embolectomy Catheter recalled | LeMaitre Vascular | Other | Nationwide |
| Device | CLASS II | Endovascular Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled | Stryker Sustainability Solutions | Particulate Matter | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |