Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
MIC-KEY* Gastric-Jejunal Feeding Tube Kit Recalled by Avanos Medical, Inc. Due to The IFU was missing some risk information requested...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Avanos Medical, Inc. directly.
Affected Products
MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx (Non-ENFIT); and MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Extension Sets with ENFit Connectors, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 8270xx, sterile, all product codes beginning with the following numbers: 1. 0270-14- - 14 Fr, all sizes except 6.0 cm and 6.5 cm - Non-ENFit; 2. 0270-16- - 16 Fr, all sizes except 6.0 cm and 6.5 cm - Non-ENFit; 3. 0270-18- - 18 Fr, all sizes - Non-ENFit; 4. 0270-22- - 22 Fr, all sizes - Non-ENFit; 5. 8270-14- - 14 Fr, all sizes (ENFit); 6. 8270-16- - 16 Fr, all sizes (ENFit); 7. 8270-18- - 18 Fr, all sizes (ENFit); 8. 8270-22- - 22 Fr, all sizes (ENFit).
Quantity: 53,384 kits
Why Was This Recalled?
The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Avanos Medical, Inc.
Avanos Medical, Inc. has 37 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report