The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1246-2024·Announced 2024-03-13

Aesculap Disposable Trocars with Dilating Pins Recalled for Packaging Damage

Aesculap Inc is recalling disposable trocars with dilating pins due to potential sterile blister packaging damage that may compromise sterility. The affected product (code EK236SU) was 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 a risk-of-harm product (sterile surgical instruments used in invasive procedures) where injury has not yet been reported. The potential for serious post-operative infection from non-sterile surgical devices in a Class II recall justifies a High severity rating.

Plain-English summary

Aesculap Inc is recalling the Disposable Trocar with Dilating Pin (12/110mm, Product Code EK236SU) used in laparoscopic surgical procedures. The recall was initiated due to potential damage to the sterile blister packaging, which may compromise the sterility of the device.

The affected batch is 52580815 with an expiration date of December 8, 2023. The product was distributed worldwide, with US distribution in Kansas, New Jersey, and New York, as well as in Canada.

Non-sterile surgical instruments could pose a risk of serious infection when used in surgical procedures. Hospitals and surgical centers that received affected units should stop using them and contact Aesculap Inc for instructions on return or disposal.

Patients who have undergone laparoscopic procedures using potentially affected devices should consult with their healthcare provider if they experience signs of infection, such as fever, wound pain, redness, or discharge.

The recalled product

Product
DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscopic procedures.
Manufacturer
Aesculap Inc
Category
Medical Device — Surgical Instruments / Laparoscopic
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: EK236SU
  • UDI/DI: 04046963620479
  • Batch Numbers (Expiration Date): 52580815 (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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