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U.S. Department of Health and Human Services

Class 2 Device Recall AESCULAP

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 Class 2 Device Recall AESCULAPsee related information
Date Initiated by FirmSeptember 24, 2025
Date PostedOctober 24, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0312-2026
Recall Event ID 97649
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
ProductBrand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog Number: EK087P Software Version: N/A Product Description: REDUCING CONVERTER 10/12MM TO 5MM Component: N/A
Code Information Model No EK087P; UDI-DI: 04046963620059; Lots 52974276, 52952133, 52954633, 52959357, 52964442, 52968887, 52972214, 52977427, 52981208, 52985519, 52988828, 52992514, 52993617, 52997919, 53002094, 53004347, 53006380, 53007625, 53010869, 53013557
FEI Number 2916714
Recalling Firm/
Manufacturer		 Aesculap Inc
3773 Corporate Pkwy
Center Valley PA 18034-8217
For Additional Information ContactAllison Longenhagen
001-484-2408371
Manufacturer Reason
for Recall		It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn September 24, 2025 URGENT MEDICAL DEVICE RECALL NOTIFICATION letters were sent to customers. Actions to be taken. 1. Review the recall notice and ensure all users in the organization are notified. Forward this notification to customers. Remove affected units from inventory, quarantine the product but do not destroy it. Complete and return the included response form. Return affected units to the firm. Credit of the product will be issued. An alternative disposable universal seal is available and can be ordered.
Quantity in Commerce155 units
DistributionWorldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, MD, NE, NM, NY, OR, PA, WA, WI and the country of Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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