The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1243-2024·Announced 2024-03-13

Aesculap Disposable Trocar with Dilating Pin Recalled for Compromised Sterility

Aesculap Inc is recalling Disposable Trocars with Dilating Pins (Product Code EK224SU) due to potentially damaged sterile blister packaging that may compromise sterility. Affected units were distributed in the US and Canada.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving a surgical instrument with potential sterility compromise. No illnesses or injuries have been reported in the source text. Per FDA rubric criteria, this qualifies as High severity as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Aesculap Inc is recalling specific lots of its Disposable Trocar with Dilating Pin (Product Code EK224SU), a medical device used in laparoscopic surgical procedures. The recall was issued because the sterile blister packaging of affected units may be damaged, which could compromise the sterility of the device.

The affected product was distributed worldwide, with US distribution in Kansas, New Jersey, and New York, as well as in Canada. The recalled lots are: Batch 52658689 (expiration 12/08/2023), Batch 52625350 (expiration 07/31/2025), and Batch 52567841 (expiration 11/30/2024). Each package contains 12 pieces.

Healthcare facilities and surgical centers that have received this product should stop using the affected batches and contact Aesculap Inc for instructions on return or replacement. If any packages appear damaged or if there are concerns about sterility, the device should not be used in any surgical procedures.

The recalled product

Product
DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures.
Manufacturer
Aesculap Inc
Category
Medical Device — Surgical instruments / Laparoscopic
Hazard
Affected units
12

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Product Code: EK224SU
  • UDI/DI: 04046963620424
  • Batch Numbers (Expiration Date): 52658689 (12/08/2023)
  • 52625350 (07/31/2025)
  • 52567841 (11/30/2024)

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Aesculap Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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