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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

ASPEN SURGICAL: Endoscopic Kittner Dissecting Instruments Recalled for Sterile Barrier Defect

Agency Publication Date: June 27, 2024
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Summary

Aspen Surgical is recalling 1,900 units of the Endoscopic Kittner Blunt Dissecting Instrument (Model KT-9101) because the sterile barrier seal on the packaging may be defective. This medical device is intended for blunt tissue dissection, and a compromised seal could allow the instrument to become contaminated. Consumers should verify if they have the affected lot numbers and contact the manufacturer immediately for instructions.

Risk

A defect in the sterile barrier seal may compromise the integrity of the product's sterility. If a non-sterile instrument is used during a surgical procedure, it poses a risk of introducing infections or pathogens directly into the patient's body.

What You Should Do

  1. Check your inventory for the Endoscopic Kittner Blunt Dissecting Instrument (Model KT-9101) with UDI-DI 00840113214006.
  2. Identify if your product belongs to one of the following affected lot numbers: 389571, 389576, 390981, or 390982.
  3. Immediately stop using any instruments from the affected lots and quarantine them to prevent accidental use.
  4. Contact Aspen Surgical at their Caledonia, Michigan facility or through their customer service channels to arrange for the return or replacement of the defective units.
  5. Consult with a healthcare provider if you have concerns regarding a procedure where this device may have been used.
  6. Contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer Notification and Device Return

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

Affected Products

Product: Endoscopic Kittner Blunt Dissecting Instrument
Model / REF:
KT-9101
UPC Codes:
00840113214006
Lot Numbers:
389571
389576
390981
390982

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94778
Status: Active
Manufacturer: ASPEN SURGICAL
Sold By: Aspen Surgical distributors
Manufactured In: United States
Units Affected: 1900 units
Distributed To: Nationwide

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.