CLASS II ONGOING Device recall · Reported 24 Jul 2024 · FDA Enforcement Report

Surgicel Fibrillar 1INX2IN(2.5CMX5., Product Number recalled

Ethicon Sarl a Johnson & Johnson is recalling Surgicel Fibrillar 1INX2IN(2.5CMX5., Product Number: 1961, distributed nationwide in the US. The recall was initiated on 11 Jun 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Number: 1961; UDI/DI: 10705031003118 (primary), 20705031003115 (box of 10); Lot numbers: TFB9151, TEB6531, TFB8781, TEB6861, TEB6511, SKE2201, SKE2101, TDB5981, SLE4411, TEB7821, TGB9291, SBB2291, TEB6411, TEB7071, TBB2481, TBB2491, TCB4081, TCB3751, TCB3781, TEB7211, TEB6871, TEB7601, TEB6521, TCB3351, SJE0361, TCB4071, TCB4481, TCB2931, TFB8381, TGB9801, TBB1511, SJE0241, SDB5001, RPE3591, RPE3181, RME2541, TBB1661, TCB4061, TCB4471, TCB4051, SKE2111, SKE1811, SKE1791, SJB9871, SJE0231, SHB9841, TJE1191, TDB5991, TGB9301, TDB5611, TDB5621, TFB8361, SKE1781, SKE1801, TFB8001, TFB8371, TJE1201, TCB3341, TDB5631, TDB5151, TDB6001;

Quantity recalled450,793 units (65,950 US, 384,843 OUS)

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-2406-2024
FDA event ID: 94831
Recalling firm: Ethicon Sarl a Johnson & Johnson, Neuchatel
Classification: Class II
Status: Ongoing
Recall initiated: 11 Jun 2024
FDA classified: 17 Jul 2024
Reported: 24 Jul 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

11 Jun 2024	Recall initiated by company
17 Jul 2024	Classified by FDA	+36 days
24 Jul 2024	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

Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.

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

SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961

Where it was distributed

Worldwide distribution - US Nationwide and the countries of India and Japan.

Nationwide

Questions about this recall

Why was it recalled?

Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.

Which lots are affected?

Product Number: 1961; UDI/DI: 10705031003118 (primary), 20705031003115 (box of 10); Lot numbers: TFB9151, TEB6531, TFB8781, TEB6861, TEB6511, SKE2201, SKE2101, TDB5981, SLE4411, TEB7821, TGB9291, SBB2291, TEB6411, TEB7071, TBB2481, TBB2491, TCB4081, TCB3751, TCB3781, TEB7211, TEB6871, TEB7601, TEB6521, TCB3351, SJE0361, TCB4071, TCB4481, TCB2931, TFB8381, TGB9801, TBB1511, SJE0241, SDB5001, RPE3591, RPE3181, RME2541, TBB1661, TCB4061, TCB4471, TCB4051, SKE2111, SKE1811, SKE1791, SJB9871, SJE0231, SHB9841, TJE1191, TDB5991, TGB9301, TDB5611, TDB5621, TFB8361, SKE1781, SKE1801, TFB8001, TFB8371, TJE1201, TCB3341, TDB5631, TDB5151, TDB6001;

Where was it sold?

Worldwide distribution - US Nationwide and the countries of India and 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

1 other product · FDA event 94831

Reported	Class	Recall	Company	Reason	Where
24 Jul 2024	CLASS II	Surgicel Fibrillar 1INX2IN(2.5CMX5., Product Number recalled	Ethicon Sarl a Johnson & Johnson	Sterility	Nationwide

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Reported	Class	Recall	Company	Reason	Where
24 Jul 2024Device	CLASS II	Surgicel Fibrillar 1INX2IN(2.5CMX5., Product Number recalled	Ethicon Sarl a Johnson & Johnson	Sterility	Nationwide

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