AVANOS 95667Recalls & reported problems
Avanos Medical, Inc. · MIC-KEY* Gastric-Jejunal Feeding Tube Kit · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00350770956671), received between May 25, 2023 and May 25, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Fungus in Device Environment” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- May 31, 2024Open, Classified
The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.
Z-2422-2024 · Root cause: Error in labeling · Recall details · FDA record ↗
Most reported problems
Device problems
- Fungus in Device Environment1
Patient problems
- Bacterial Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 25, 2023Fungus in Device Environment; Fungus in Device Environment
IT WAS REPORTED THAT ¿BLACK DOTS¿ WERE NOTED IN THE PATIENT¿S LOW PROFILE 18FR 3.0CM GASTRIC-JEJUNAL (GJ) TUBE. THE PATIENT WAS RECENTLY ADMITTED INTO THE HOSPITAL FOR A BLOOD INFECTION, AND THEY WERE WONDERING IF [THE INFECTION] CAME FROM THE [BLACK DOTS IN THE TUBE]. IT WAS ADDITIONALLY REPORTED, THE [ORDERING PHYSICIAN] SAW THE BLACK DOTS AND SAID THAT IF THE TUBE WAS FUNCTIONING TO CONTINUE USING IT. ADDITIONAL INFORMATION RECEIVED 04MAY2023 REPORTED, THE PATIENT WAS ADMITTED ON (B)(6) 2023, AND THE CULTURE CAME BACK POSITIVE FOR ENTEROCOCCAL BACTEREMIA; THE PATIENT WAS PRESCRIBED VANCO AND WAS RELEASED HOME. ADDITIONAL INFORMATION RECEIVED 11MAY2023 REPORTED, THE PATIENT WAS SCHEDULED TO HAVE THE TUBE REPLACED ON (B)(6) 2023.
Patient problems: Bacterial Infection
MAUDE report 17006004 ↗
Other Tubes, gastrointestinal (and accessories) devices
- Bard® DigniShield® Stool Management System SMS002C. R. Bard, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)2 deaths525 reports
- CORTRAK* 2 ENTERAL ACCESS SYSTEM 20-0950Avanos Medical, Inc. · Tubes, gastrointestinal (and accessories)1 recall22 deaths134 reports
- Bard Tri-Funnel Replacement Gastrostomy Tube 000720Bard Access Systems, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 death170 reports
- EndoVive Safety PEG Kit M00566470Boston Scientific Corporation · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 recall1 death111 reports
- Kangaroo 8884711253Cardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)152 reports
- NutraGlide Nasal Feeding Tube ENFT-05055-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- NutraGlide Nasal Feeding Tube ENFT-06090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- NutraGlide Nasal Feeding Tube ENFT-06055-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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