CLASS II ONGOING Device recall · Reported 13 Mar 2024 · FDA Enforcement Report

Disp.Trocar W.Dilating Pin, Product recalled by Aesculap

Aesculap is recalling Disp.Trocar W.Dilating Pin, Product, distributed nationwide in the US. The recall was initiated on 9 Jan 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code: EK234SU; UDI/DI: 04046963620462; Batch Numbers (Expiration Date): 52573073 (12/08/2023);

Quantity recalled6 pieces

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-1245-2024
FDA event ID: 93856
Recalling firm: Aesculap, Center Valley, PA
Classification: Class II
Status: Ongoing
Recall initiated: 9 Jan 2024
FDA classified: 1 Mar 2024
Reported: 13 Mar 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

9 Jan 2024	Recall initiated by company
1 Mar 2024	Classified by FDA	+52 days
13 Mar 2024	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

The sterile blister packaging may be damaged, and sterility may be compromised.

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

DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparoscopic procedures.

Where it was distributed

Worldwide - US Nationwide distribution in the states of KS, NJ and NY. The country of Canada.

Nationwide Kansas New Jersey New York

Questions about this recall

Is Disp.Trocar W.Dilating Pin, Product recalled?

Yes. Aesculap recalled Disp.Trocar W.Dilating Pin, Product on 9 Jan 2024. The recall is Class II and its status is Ongoing. Recall number Z-1245-2024.

Why was it recalled?

The sterile blister packaging may be damaged, and sterility may be compromised.

Which lots are affected?

Product Code: EK234SU; UDI/DI: 04046963620462; Batch Numbers (Expiration Date): 52573073 (12/08/2023);

Where was it sold?

Worldwide - US Nationwide distribution in the states of KS, NJ and NY. 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.

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