CLASS II ONGOING Device recall · Reported 5 Nov 2025 · FDA Enforcement Report

Sealing Unit F/ Trocars W.reducer recalled by Aesculap

Aesculap is recalling Aesculap Sealing Unit F/ Trocars W.Reducer, distributed nationwide in the US. The recall was initiated on 24 Sep 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel No EK083P; UDI-DI: 04046963417710; Lots 52978946, 52991996, 53002275, 53004669, 53006807, 52941286, 52956527, 52956740, 52956952, 52957393, 52967167

Quantity recalled26 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-0309-2026
FDA event ID: 97649
Recalling firm: Aesculap, Center Valley, PA
Classification: Class II
Status: Ongoing
Recall initiated: 24 Sep 2025
FDA classified: 24 Oct 2025
Reported: 5 Nov 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Surgical Instruments

Timeline

24 Sep 2025	Recall initiated by company
24 Oct 2025	Classified by FDA	+30 days
5 Nov 2025	Published in enforcement report	+12 days

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

Reason for recall

It was determined there is the potential of silicone fragments detaching from the yellow sealing component.

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

Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Version: N/A Product Description: SEALING UNIT F/10/12MM TROCARS W.REDUCER Component: N/A

Where it was distributed

Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, MD, NE, NM, NY, OR, PA, WA, WI and the country of Canada.

Nationwide Arkansas Arizona California Connecticut Maryland Nebraska New Mexico New York Oregon Pennsylvania Washington Wisconsin

Questions about this recall

Is Sealing Unit F/ Trocars W.reducer recalled?

Yes. Aesculap recalled Sealing Unit F/ Trocars W.reducer on 24 Sep 2025. The recall is Class II and its status is Ongoing. Recall number Z-0309-2026.

Why was it recalled?

It was determined there is the potential of silicone fragments detaching from the yellow sealing component.

Which lots are affected?

Model No EK083P; UDI-DI: 04046963417710; Lots 52978946, 52991996, 53002275, 53004669, 53006807, 52941286, 52956527, 52956740, 52956952, 52957393, 52967167

Where was it sold?

Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, MD, NE, NM, NY, OR, PA, WA, WI and the country of Canada.

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 Aesculap

All 40

Reported	Class	Recall	Company	Reason	Where
11 Mar 2026Device	CLASS II	Minop Trocar 4 Wking Channel6 recalled by Aesculap	Aesculap	Device Malfunction	Nationwide
5 Nov 2025Device	CLASS II	Sealing Unit For Trocars recalled by Aesculap	Aesculap	Packaging Defects	Nationwide
5 Nov 2025Device	CLASS II	Sealing Cap For Trocars recalled by Aesculap	Aesculap	Packaging Defects	Nationwide
5 Nov 2025Device	CLASS II	Reducing Converter To recalled by Aesculap	Aesculap	Packaging Defects	Nationwide
19 Mar 2025Device	CLASS II	Numerous models of nonsterile hemostatic forceps: (1) REF BH198R recalled	Aesculap	Sterility	Nationwide

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