Aesculap Hasson trocar recalled due to sterility packaging concerns
Aesculap Inc has recalled Hasson trocar surgical instruments (18 units) because sterile blister packaging may be damaged and sterility compromised. The recall affects the U.S. (Kansas, New Jersey, New York) 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 of a sterile surgical device where packaging damage may compromise sterility. No illnesses or injuries have been reported. The hazard—infection risk from non-sterile instruments during surgery—is significant but theoretical, placing this at High severity.
Plain-English summary
Aesculap Inc is recalling HASSON TROCAR 10/110MM surgical instruments (Product Code EK230SU, 18 units) used in laparoscopic surgical procedures. The recalled batch numbers are 52481826 (expiration 02/29/2024) and 52644661 (expiration 02/28/2026).
The sterile blister packaging may be damaged, which could compromise the sterility of the instruments. Non-sterile surgical instruments pose an infection risk during surgical use.
The affected devices were distributed nationwide in Kansas, New Jersey, and New York, as well as Canada. Healthcare facilities and practitioners who received these devices should cease using them and contact Aesculap Inc for information on returns or replacement.
The recalled product
- Product
- DISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic procedures.
- Manufacturer
- Aesculap Inc
- Affected units
- 18
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 (4)
- Product Code: EK230SU
- UDI/DI: 04046963620455
- Batch Numbers (Expiration Date): 52481826 (02/29/2024)
- 52644661 (02/28/2026)
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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