CLASS II Device recall · Reported 3 Jul 2019 · FDA Enforcement Report

Ethicon Enseal X1 Curved Jaw Tissue Sealer Shaft Product recalled

Ethicon Endo-Surgery is recalling Ethicon Enseal X1 Curved Jaw Tissue Sealer Shaft, distributed nationwide in the US. The recall was initiated on 15 May 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lot numbers

Quantity recalled1059 boxes

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-1889-2019
FDA event ID: 82973
Recalling firm: Ethicon Endo-Surgery, Blue Ash, OH
Classification: Class II
Status: Terminated
Recall initiated: 15 May 2019
FDA classified: 26 Jun 2019
Reported: 3 Jul 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

15 May 2019	Recall initiated by company
26 Jun 2019	Classified by FDA	+42 days
3 Jul 2019	Published in enforcement report	+7 days

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

Reason for recall

Observed reported incidence rate for harm associated with intraoperative bleeding

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft PRODUCT CODE: NSLX137C

Where it was distributed

Nationwide Foreign: CANADA, AUSTRALIA, BELGIUM

Nationwide

Questions about this recall

Why was it recalled?

Observed reported incidence rate for harm associated with intraoperative bleeding

Which lots are affected?

All lot numbers

Where was it sold?

Nationwide Foreign: CANADA, AUSTRALIA, BELGIUM

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.

Other products in this recall event

2 other products · FDA event 82973

This product is part of a recall event; the main page for the event is Ethicon Enseal X1 Curved Jaw Tissue Sealer Shaft Product recalled.

Reported	Class	Recall	Company	Reason	Where
3 Jul 2019	CLASS II	Ethicon Enseal X1 Curved Jaw Tissue Sealer Shaft Product recalled	Ethicon Endo-Surgery	Packaging Defects	Nationwide
3 Jul 2019	CLASS II	Ethicon Enseal X1 Curved Jaw Tissue Sealer Shaft Product recalled	Ethicon Endo-Surgery	Packaging Defects	Nationwide

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