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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

MICROspecialties, Inc.: Injection Kits Recalled for Potential Sterilization Failure and Infection Risk

Agency Publication Date: July 11, 2024
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Summary

MICROspecialties, Inc. is recalling 3,996 units of several Synergetics I Pack Injection Kits used for ophthalmic (eye) procedures. The company cannot confirm that these kits were exposed to the proper sterilization cycle during manufacturing, which could lead to the use of non-sterile equipment. While no specific injuries have been reported in the provided data, the affected kits were distributed in Missouri and include various models like the standard injection kit, kits with drapes, and custom trays. Consumers and healthcare facilities should contact their provider or the manufacturer for instructions on how to handle these products.

Risk

If the products were not properly sterilized, they may carry bacteria or other pathogens that can cause serious post-operative wound infections or injection site infections in the eye.

What You Should Do

  1. Identify your product by checking the model and lot numbers on the packaging for the following affected kits: Synergetics I Pack Injection Kit (Model 18060, Lot P62764979R), I-Pack with Drape (Model 18061, Lot P63044983R), I Pack Custom (Model 18069, Lot P62764965R), or I Pack with Wire Speculum (Model 18069W, Lot P62764970R).
  2. Verify the Universal Device Identifier (UDI) codes on the labels: 10841305101064, 10841305101071, 10841305101125, or 10841305101132.
  3. Stop using these kits immediately and secure any remaining inventory to ensure they are not used in medical procedures.
  4. Contact your healthcare provider if you have recently undergone a procedure involving these kits and are experiencing signs of infection, such as redness, pain, or swelling at the injection site.
  5. Contact MICROspecialties, Inc. at their Middletown, CT facility for further instructions regarding the return or disposal of the affected kits and potential refunds.
  6. For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact healthcare provider or manufacturer

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

Affected Products

Product: Synergetics I Pack Injection Kit- Tray for use with Ophthalmic injections
Model / REF:
18060
UPC Codes:
10841305101064
Lot Numbers:
P62764979R
Product: Synergetics I-Pack Injection Kit with Drape -For use with Ophthalmic injections
Model / REF:
18061
UPC Codes:
10841305101071
Lot Numbers:
P63044983R
Product: Synergetics I Pack Injection Kit Custom-Tray for use with Ophthalmic injections
Model / REF:
18069
UPC Codes:
10841305101125
Lot Numbers:
P62764965R
Product: Synergetics I Pack Injection Kit with Wire Speculum- Tray for use in Opthalmic Injection
Model / REF:
18069W
UPC Codes:
10841305101132
Lot Numbers:
P62764970R

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94794
Status: Active
Manufacturer: MICROspecialties, Inc.
Manufactured In: United States
Units Affected: 4 products (2316 units; 96 units; 780 units; 804 units)
Distributed To: Missouri

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.