CLASS II ONGOING Device recall · Reported 22 Oct 2025 · FDA Enforcement Report

Echelon Linear Cutters Reload Blue, intended recalled

Ethicon Endo-Surgery is recalling Echelon Linear Cutters Reload Blue, intended for transection, resection, and/or creation, distributed nationwide in the US. The recall was initiated on 11 Sep 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 10705036030881; Lot Number: 904C12

Quantity recalled3 units

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-0147-2026
FDA event ID: 97654
Recalling firm: Ethicon Endo-Surgery, Blue Ash, OH
Classification: Class II
Status: Ongoing
Recall initiated: 11 Sep 2025
FDA classified: 14 Oct 2025
Reported: 22 Oct 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

11 Sep 2025	Recall initiated by company
14 Oct 2025	Classified by FDA	+33 days
22 Oct 2025	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The devices were shipped unsterilized.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80

Where it was distributed

International distribution to the countries of United Arab Emirates.

Nationwide

Questions about this recall

Is Echelon Linear Cutters Reload Blue, intended for transection, resection, and/or creation recalled?

Yes. Ethicon Endo-Surgery recalled Echelon Linear Cutters Reload Blue, intended for transection, resection, and/or creation on 11 Sep 2025. The recall is Class II and its status is Ongoing. Recall number Z-0147-2026.

Why was it recalled?

The devices were shipped unsterilized.

Which lots are affected?

UDI-DI: 10705036030881; Lot Number: 904C12

Where was it sold?

International distribution to the countries of United Arab Emirates.

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 21 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

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28 May 2025Device	CLASS I	Endopath Echelon Vascular White Reload recalled by Ethicon Endo-Surgery	Ethicon Endo-Surgery	Other	Nationwide
9 Apr 2025Device	CLASS II	Pdsii¿vio¿¿usp6-0(m0.7)¿d/a¿c recalled by Ethicon Endo Surgery	Ethicon Endo Surgery	Other	Nationwide
9 Apr 2025Device	CLASS II	Ethibond Excel Grn Usp2-0(m3) D/a Mh recalled by Ethicon Endo Surgery	Ethicon Endo Surgery	Other	Nationwide
9 Apr 2025Device	CLASS II	Prolene Blu Usp6-0(m0.7) S/a P-1 Prm recalled by Ethicon Endo Surgery	Ethicon Endo Surgery	Other	Nationwide
9 Apr 2025Device	CLASS II	Pds¿plus¿vio¿¿usp6-0(m0.7)¿d/a¿c-1¿mp recalled	Ethicon Endo Surgery	Other	Nationwide

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