Aesculap Hasson Trocar Recall Due to Potentially Compromised Sterile Packaging
Aesculap Inc recalls Disposable Hasson Trocars (EK240SU) due to potentially damaged sterile packaging that may compromise sterility. Batch 52581648 distributed in KS, NJ, NY, and Canada requires immediate discontinuation.
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 medical device recall involving potentially compromised sterility due to damaged packaging. The source text does not report any illnesses, injuries, or adverse events. Per the severity rubric, risk-of-harm products without reported harm receive a score of 3 (High).
Plain-English summary
Aesculap Inc is recalling Disposable Hasson Trocars (Product Code EK240SU) used in laparoscopic surgical procedures. The recall affects Batch 52581648, which has an expiration date of 01/31/2025.
The sterile blister packaging protecting these trocars may be damaged, which could compromise the sterility of the instruments. Sterile surgical equipment is essential for safe laparoscopic procedures.
These trocars were distributed nationwide in Kansas, New Jersey, and New York, as well as in Canada.
Hospitals and surgical facilities that have received these trocars should immediately discontinue use of Batch 52581648. Check your inventory against the affected batch number and quarantine any matching units. Contact Aesculap Inc for return or replacement instructions.
The recalled product
- Product
- DISP.HASSON TROCAR 12/110MM, Product Code EK240SU. For use in laparoscopic procedures.
- Manufacturer
- Aesculap Inc
- 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: EK240SU
- UDI/DI: 04046963620493
- Batch Numbers (Expiration Date): 52581648 (01/31/2025)
Distribution
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.
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