CLASS II ONGOING Device recall · Reported 1 Jan 2020 · FDA Enforcement Report

Lamicel INTL recalled by Medtronic Xomed

Medtronic Xomed is recalling Lamicel INTL. The recall was initiated on 13 Nov 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 20885074749055; SPONGE 2203-501EX LAMICEL 20PK 5MM INTL; 2203-501EX; Lots 9642542, 9657414, 9657415, 9657416, 9677915, 9707331, 9707338, 9707334, 9712918

Quantity recalled307 packs; 6140 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-0734-2020
FDA event ID: 84332
Recalling firm: Medtronic Xomed, Jacksonville, FL
Classification: Class II
Status: Ongoing
Recall initiated: 13 Nov 2019
FDA classified: 23 Dec 2019
Reported: 1 Jan 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

13 Nov 2019	Recall initiated by company
23 Dec 2019	Classified by FDA	+40 days
1 Jan 2020	Published in enforcement report	+9 days

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

Reason for recall

Routine sterilization dose does not meet the required Sterility Assurance Level.

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

Lamicel 20PK 5MM INTL

Where it was distributed

Affected product was only distributed in Japan.

Questions about this recall

Why was it recalled?

Routine sterilization dose does not meet the required Sterility Assurance Level.

Which lots are affected?

UDI: 20885074749055; SPONGE 2203-501EX LAMICEL 20PK 5MM INTL; 2203-501EX; Lots 9642542, 9657414, 9657415, 9657416, 9677915, 9707331, 9707338, 9707334, 9712918

Where was it sold?

Affected product was only distributed in Japan.

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 84332

This product is part of a recall event; the main page for the event is Lamicel INTL recalled by Medtronic Xomed.

Reported	Class	Recall	Company	Reason	Where
1 Jan 2020	CLASS II	Lamicel INTL recalled by Medtronic Xomed	Medtronic Xomed	Sterility	FL
1 Jan 2020	CLASS II	Lamicel INTL Cervical dilator recalled by Medtronic Xomed	Medtronic Xomed	Sterility	FL

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