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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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Critical RiskFDA Device
Medical Devices/Home Healthcare

Avanos Medical, Inc.: MIC* Gastric-Jejunal Feeding Tube Kits Recalled for Syringe Contamination

Agency Publication Date: March 1, 2024
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Summary

Avanos Medical, Inc. is recalling 63,934 MIC* Gastric-Jejunal Feeding Tube Kits because they contain a sterile pre-filled syringe that was manufactured and previously recalled by Nurse Assist due to potential sterility issues. These feeding tube kits are used to provide nutrition directly into the stomach and small intestine for patients who cannot eat normally. If the contaminated syringe is used during the placement or maintenance of the feeding tube, it could introduce harmful bacteria or fungi into a patient's system, leading to serious infections. These kits were distributed worldwide, including throughout the United States, between approximately January 2024 and March 2024.

Risk

The pre-filled syringes included in these kits may not be sterile, which can cause life-threatening infections in patients who are already medically fragile. While no specific injuries were reported for this secondary recall, the original syringe manufacturer's recall was initiated due to the risk of bacterial contamination.

What You Should Do

  1. Check your feeding tube kit packaging for the product name 'MIC* Gastric-Jejunal Feeding Tube Kit' and locate the Product Code and Batch Number on the label.
  2. Verify if your kit is affected by checking for Product Codes 8250-16, 8250-18, 8250-22, 8260-16, 8260-18, 8260-22 (with various extensions like -15, -22, -30) and matching the Batch Numbers such as 30180762, 30226671, 30226823, or any of the over 100 specific batch codes listed in the recall notice.
  3. Identify if your kit is the GJ-Tube version with Product Codes starting with 0250- or 0260- and check for batch numbers like 30180718, 30181870, or 30248036.
  4. Stop using the affected feeding tube kits immediately if they contain the recalled Nurse Assist syringe.
  5. Contact your healthcare provider or Avanos Medical, Inc. directly at their headquarters in Alpharetta, Georgia, for instructions on how to return the product and obtain a replacement or refund.
  6. Call the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding this safety alert.

Your Remedy Options

📋Other Action

Manufacturer initiated product correction/removal due to sterile syringe component recall.

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

Affected Products

Product: MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors
Model / REF:
8250-16
8250-16-15
8250-16-22
8250-16-30
8250-18
8250-18-22
8250-18-30
8250-22
8260-16
8260-18
8260-22
Lot Numbers (106):
30180762
30226671
30226823
30233440
30238985
30242039
30254749
30265005
30266483
30265374
30268260
30270862
30226822
30242228
30253956
30184814
30226821
30247088
30253955
30262508
30226820
30231400
30238125
30247087
30250300
30258135
30265373
30181846
30184760
30185381
30226672
30229833
30233376
30233439
30235094
30238124
30238984
30250140
30251089
30250169
30254748
30255675
30256486
80402128
30259225
30259566
30261699
30262040
30264284
30267593
Product: MIC* Gastric-Jejunal Feeding Tube Kit (GJ-Tube)
Model / REF:
0250-16
0250-16-15
0250-16-22
0250-16-30
0250-18
0250-18-22
0250-18-30
0250-22
0260-16
0260-18
0260-22
Lot Numbers (149):
30180718
30181870
30184758
30186768
30194327
30226669
30226817
30229831
30240299
30244886
30248036
30248348
30251106
30251988
30254746
30258134
30267592
30185370
30194326
30249243
30256710
30226808
30238975
30184813
30186749
30190699
30226816
30235093
30245070
30181844
30181869
30184757
30185369
30186748
30189492
30190698
30195869
30226668
30226815
30228967
30229830
30238122
30238885
30239857
30238982
30240298
30240451
30243197
30242224
30244885

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93907
Status: Active
Manufacturer: Avanos Medical, Inc.
Sold By: Hospital supply distributors; Medical device retailers
Manufactured In: United States
Units Affected: 2 products (10808 units; 53126 Units)
Distributed To: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, Puerto Rico

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 · FDA Press Release · 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.