CLASS II Device recall · Reported 2 May 2018 · FDA Enforcement Report

Evicel Accessory Device - Flexible Tip (SET OF , Product recalled

Ethicon is recalling Evicel Accessory Device - Flexible Tip (SET OF , Product, distributed in 27 states. The recall was initiated on 7 Mar 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 17-0102

Quantity recalled738 devices (246 boxes of 3)

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-1534-2018
FDA event ID: 79668
Recalling firm: Ethicon, Somerville, NJ
Classification: Class II
Status: Terminated
Recall initiated: 7 Mar 2018
FDA classified: 26 Apr 2018
Reported: 2 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

7 Mar 2018	Recall initiated by company
26 Apr 2018	Classified by FDA	+50 days
2 May 2018	Published in enforcement report	+6 days

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

Reason for recall

Products labeled for distribution outside the United States may have been distributed to customers in the United States.

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

Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. Accessory Tips for use only with EVICEL Fibrin Sealant (Human) Application Device.

Where it was distributed

The device was distributed to the following states: AK, AL, AR, AZ, CA, CO, FL, GA, IA, IL MD, MI, MN, MO, NC, ND, NJ, NV, NY, OH, PA, TN, TX, WA, WI, and WV. The device was also distributed to Puerto Rico.

Alaska Alabama Arkansas Arizona California Colorado Florida Georgia Iowa Illinois Maryland Michigan Minnesota Missouri North Carolina North Dakota New Jersey Nevada New York Ohio

Questions about this recall

Is Evicel Accessory Device - Flexible Tip (SET OF , Product recalled?

Yes. Ethicon recalled Evicel Accessory Device - Flexible Tip (SET OF , Product on 7 Mar 2018. The recall is Class II and its status is Terminated. Recall number Z-1534-2018.

Why was it recalled?

Products labeled for distribution outside the United States may have been distributed to customers in the United States.

Which lots are affected?

Lot 17-0102

Where was it sold?

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

All 76

Reported	Class	Recall	Company	Reason	Where
1 Oct 2025Device	CLASS II	Stratafix Spiral PDS Plus Bidirectional Knotless Tissue recalled	Ethicon	Other	Nationwide
12 Feb 2025Device	CLASS II	Perma-hand Silk Suture recalled by Ethicon	Ethicon	Lead & Heavy Metals	Nationwide
12 Feb 2025Device	CLASS II	Ethibond Excel Polyester Suture recalled by Ethicon	Ethicon	Lead & Heavy Metals	Nationwide
12 Feb 2025Device	CLASS II	Prolene Polypropylene Suture recalled by Ethicon	Ethicon	Lead & Heavy Metals	Nationwide
27 Nov 2024Device	CLASS II	Monocryl" (poliglecaprone Suture recalled by Ethicon	Ethicon	Packaging Defects	45 states

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide