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. The recall was initiated on 11 Sep 2025 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-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
- Other Reasons
- 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.
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.
Questions about this recall
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 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
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|---|---|---|---|---|---|
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| Device | CLASS II | Pds¿plus¿vio¿¿usp6-0(m0.7)¿d/a¿c-1¿mp recalled | Ethicon Endo Surgery | Other | Nationwide |
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