Aesculap Inc: Surgical Trocars Recalled for Damaged Packaging and Loss of Sterility

Agency Publication Date: March 1, 2024

Summary

Aesculap Inc. is recalling 48 units of various disposable laparoscopic trocars because the sterile blister packaging may be damaged. This defect could compromise the sterility of the instruments, which are used to create ports in the body during laparoscopic surgeries. Approximately 48 pieces were distributed worldwide, including to healthcare facilities in Canada and three U.S. states. Consumers should contact their healthcare provider or the manufacturer to ensure no potentially non-sterile devices are used in medical procedures.

Risk

The compromised packaging allows the medical devices to be exposed to environmental contaminants. Using non-sterile surgical instruments during a laparoscopic procedure increases the risk of infection or other serious complications for the patient.

What You Should Do

Identify if you have the affected 10/110mm Dilating Pin Trocars (Product Code EK224SU) by checking for batch numbers 52658689 (Exp 12/08/2023), 52625350 (Exp 07/31/2025), or 52567841 (Exp 11/30/2024).
Check for affected 10/110mm Hasson Trocars (Product Code EK230SU) with batch numbers 52481826 (Exp 02/29/2024) or 52644661 (Exp 02/28/2026).
Look for 12/110mm Dilating Pin Trocars with Product Code EK234SU (Batch 52573073, Exp 12/08/2023) or Product Code EK236SU (Batch 52580815, Exp 12/08/2023).
Inspect 12/110mm Hasson Trocars (Product Code EK240SU) for batch number 52581648 with an expiration date of 01/31/2025.
Immediately set aside any products matching these identifiers and do not use them in surgical procedures.
Contact Aesculap Inc. or your healthcare provider for further instructions regarding the return or replacement of these devices and to discuss potential refunds.
For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Contact healthcare provider or manufacturer

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: DISP.TROCAR W. DILATING PIN 10/110MM

Model / REF:

EK224SU

UPC Codes:

04046963620424

Lot Numbers:

52658689 (Exp 12/08/2023)

52625350 (Exp 07/31/2025)

52567841 (Exp 11/30/2024)

Product: DISP.HASSON TROCAR 10/110MM

Model / REF:

EK230SU

UPC Codes:

04046963620455

Lot Numbers:

52481826 (Exp 02/29/2024)

52644661 (Exp 02/28/2026)

Product: DISP.TROCAR W.DILATING PIN 12/110MM

Model / REF:

EK234SU

UPC Codes:

04046963620462

Lot Numbers:

52573073 (Exp 12/08/2023)

Product: DISP.TROCAR W.DILATING PIN 12/110MM

Model / REF:

EK236SU

UPC Codes:

04046963620479

Lot Numbers:

52580815 (Exp 12/08/2023)

Product: DISP.HASSON TROCAR 12/110MM

Model / REF:

EK240SU

UPC Codes:

04046963620493

Lot Numbers:

52581648 (Exp 01/31/2025)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93856

Status: Active

Manufacturer: Aesculap Inc

Sold By: Specialized medical distributors; Healthcare facilities

Manufactured In: United States

Units Affected: 5 products (12 pieces; 18 pieces; 6 pieces; 6 pieces; 6 pieces)

Distributed To: Kansas, New Jersey, New York

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if you have the affected 10/110mm Dilating Pin Trocars (Product Code EK224SU) by checking for batch numbers 52658689 (Exp 12/08/2023), 52625350 (Exp 07/31/2025), or 52567841 (Exp 11/30/2024).

Check for affected 10/110mm Hasson Trocars (Product Code EK230SU) with batch numbers 52481826 (Exp 02/29/2024) or 52644661 (Exp 02/28/2026).

Look for 12/110mm Dilating Pin Trocars with Product Code EK234SU (Batch 52573073, Exp 12/08/2023) or Product Code EK236SU (Batch 52580815, Exp 12/08/2023).

Inspect 12/110mm Hasson Trocars (Product Code EK240SU) for batch number 52581648 with an expiration date of 01/31/2025.

Immediately set aside any products matching these identifiers and do not use them in surgical procedures.

Contact Aesculap Inc. or your healthcare provider for further instructions regarding the return or replacement of these devices and to discuss potential refunds.

For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: DISP.TROCAR W. DILATING PIN 10/110MM

Model / REF:

EK224SU

UPC Codes:

04046963620424

Lot Numbers:

52658689 (Exp 12/08/2023)

52625350 (Exp 07/31/2025)

52567841 (Exp 11/30/2024)

Product: DISP.HASSON TROCAR 10/110MM

Model / REF:

EK230SU

UPC Codes:

04046963620455

Lot Numbers:

52481826 (Exp 02/29/2024)

52644661 (Exp 02/28/2026)

Product: DISP.TROCAR W.DILATING PIN 12/110MM

Model / REF:

EK234SU

UPC Codes:

04046963620462

Lot Numbers:

52573073 (Exp 12/08/2023)

Product: DISP.TROCAR W.DILATING PIN 12/110MM

Model / REF:

EK236SU

UPC Codes:

04046963620479

Lot Numbers:

52580815 (Exp 12/08/2023)

Product: DISP.HASSON TROCAR 12/110MM

Model / REF:

EK240SU

UPC Codes:

04046963620493

Lot Numbers:

52581648 (Exp 01/31/2025)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93856

Status: Active

Manufacturer: Aesculap Inc

Sold By: Specialized medical distributors; Healthcare facilities

Manufactured In: United States

Units Affected: 5 products (12 pieces; 18 pieces; 6 pieces; 6 pieces; 6 pieces)

Distributed To: Kansas, New Jersey, New York