CLASS II ONGOING Device recall · Reported 22 Jan 2025 · FDA Enforcement Report

Econo Sterile medical procedure kits labeled as recalled

Sklar Instruments is recalling Econo Sterile medical procedure kits labeled as: Econo Sterile Vienna Nsl Spec MD Strl, distributed nationwide in the US. The recall was initiated on 3 Dec 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1) 96-2236, UDI/DI 50649111439757, Lot codes: SK-129, SK-130, SK-131; 2) 96-2237M, UDI/DI 50649111439764, Lot codes: SK-133; 3) 96-2238, UDI/DI 50649111439771, Lot codes: SK-131.

Quantity recalled175 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-0930-2025
FDA event ID: 95946
Recalling firm: Sklar Instruments, West Chester, PA
Classification: Class II
Status: Ongoing
Recall initiated: 3 Dec 2024
FDA classified: 16 Jan 2025
Reported: 22 Jan 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

3 Dec 2024	Recall initiated by company
16 Jan 2025	Classified by FDA	+44 days
22 Jan 2025	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

Reports of various packaging issues that may result in a breach of the sterile barrier.

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

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2236; 2) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2237M; 3) ECONO STERILE VIENNA NSL SPEC LG STRL CS/25, Model Number 96-2238; for nasal procedures

Where it was distributed

Domestic: Nationwide Distribution

Nationwide

Questions about this recall

Is Econo Sterile medical procedure kits labeled as: Econo Sterile Vienna Nsl Spec MD Strl recalled?

Yes. Sklar Instruments recalled Econo Sterile medical procedure kits labeled as: Econo Sterile Vienna Nsl Spec MD Strl on 3 Dec 2024. The recall is Class II and its status is Ongoing. Recall number Z-0930-2025.

Why was it recalled?

Reports of various packaging issues that may result in a breach of the sterile barrier.

Which lots are affected?

1) 96-2236, UDI/DI 50649111439757, Lot codes: SK-129, SK-130, SK-131; 2) 96-2237M, UDI/DI 50649111439764, Lot codes: SK-133; 3) 96-2238, UDI/DI 50649111439771, Lot codes: SK-131.

Where was it sold?

Domestic: Nationwide Distribution

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 Sklar Instruments

All 30

Reported	Class	Recall	Company	Reason	Where
22 Jan 2025Device	CLASS II	Econo Sterile medical procedure kits labeled as recalled	Sklar Instruments	Sterility	Nationwide
22 Jan 2025Device	CLASS II	Econo Sterile medical procedure kits labeled as recalled	Sklar Instruments	Sterility	Nationwide
22 Jan 2025Device	CLASS II	Econo Sterile medical procedure kits labeled as recalled	Sklar Instruments	Sterility	Nationwide
22 Jan 2025Device	CLASS II	Econo Sterile medical procedure kits labeled as recalled	Sklar Instruments	Sterility	Nationwide
22 Jan 2025Device	CLASS II	Econo Sterile medical procedure kits labeled as recalled	Sklar Instruments	Sterility	Nationwide

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