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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Aesculap Trocars and Sealing Components Recalled for Silicone Detachment

Agency Publication Date: October 24, 2025
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Summary

Aesculap Inc. is recalling approximately 347 units of sealing components for trocars, which are surgical tools used to create access points during minimally invasive procedures. It was discovered that silicone fragments could detach from the yellow sealing part of the device. This recall involves four specific models: sealing units with and without reducers, sealing caps, and reducing converters.

Risk

If silicone fragments detach from the device during a surgical procedure, they could remain inside a patient's body. This poses a risk of adverse tissue reactions, inflammation, or other post-surgical complications.

What You Should Do

  1. This recall affects Aesculap Sealing Units, Sealing Caps, and Reducing Converters for 10/12mm Trocars under model numbers EK083P, EK085P, EK086P, and EK087P.
  2. Check the packaging and labels for lot numbers such as 52978946, 52991996, 53002275, 52987668, 52968398, and 52974276. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: SEALING UNIT F/10/12MM TROCARS W.REDUCER
Model / REF:
EK083P
Lot Numbers:
52978946
52991996
53002275
53004669
53006807
52941286
52956527
52956740
52956952
52957393
52967167
UDI:
04046963417710

Recall #: Z-0309-2026; Quantity: 26 units

Product: SEALING CAP FOR 10/12MM TROCARS
Model / REF:
EK085P
Lot Numbers:
52987668
52993442
53001930
53008562
53013543
52948710
52954233
52957528
52966111
52979586
UDI:
04046963620042

Recall #: Z-0310-2026; Quantity: 140 units

Product: SEALING UNIT FOR 10/12MM TROCARS
Model / REF:
EK086P
Lot Numbers:
52968398
52975386
52988022
52993532
53008999
53009000
53009001
53009417
UDI:
04046963425272

Recall #: Z-0311-2026; Quantity: 26 units

Product: REDUCING CONVERTER 10/12MM TO 5MM
Model / REF:
EK087P
Lot Numbers:
52974276
52952133
52954633
52959357
52964442
52968887
52972214
52977427
52981208
52985519
52988828
52992514
52993617
52997919
53002094
53004347
53006380
53007625
53010869
53013557
UDI:
04046963620059

Recall #: Z-0312-2026; Quantity: 155 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97649
Status: Active
Manufacturer: Aesculap Inc
Sold By: Medical Supply Distributors; Surgical Centers; Hospitals
Manufactured In: United States
Units Affected: 4 products (26 units; 140 units; 26 units; 155 units)
Distributed To: Arkansas, Arizona, California, Connecticut, Maryland, Nebraska, New Mexico, New York, Oregon, Pennsylvania, Washington, Wisconsin

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 ยท 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.