The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1245-2024·Announced 2024-03-13

Aesculap Disposable Trocars Recalled Due to Sterile Packaging Damage Risk

Aesculap Inc is recalling disposable trocars with dilating pins (Product Code EK234SU) because their sterile blister packaging may be damaged, potentially compromising sterility. This Class II recall affects units 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: FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—packaging may be damaged and sterility may be compromised—but surgical devices where sterility is compromised present a high risk of patient harm through infection.

Plain-English summary

Aesculap Inc is recalling the Disposable Trocar with Dilating Pin (Product Code EK234SU, 12/110MM) used in laparoscopic surgical procedures. The recalled batch number is 52573073, which expired December 8, 2023.

The sterile blister packaging for these trocars may be damaged, potentially compromising the sterility of the devices. Sterile surgical instruments are critical to maintaining safety during surgical procedures.

The affected products were distributed nationwide in Kansas, New Jersey, and New York, as well as in Canada.

Healthcare facilities and surgical centers that have received this product should stop using the affected batch immediately. Contact Aesculap Inc with questions about the recall or for information on obtaining replacements.

The recalled product

Product
DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparoscopic procedures.
Manufacturer
Aesculap Inc
Category
Medical Device — Surgical Instruments
Hazard
Affected units
6

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 (3)

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

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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