CLASS II ONGOING Device recall · Reported 31 Jul 2024 · FDA Enforcement Report
Mic-key* Gastric-Jejunal Feeding Tube Kit recalled by Avanos Medical
Avanos Medical is recalling Mic-key* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile, distributed nationwide in the US. The recall was initiated on 31 May 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2422-2024
- FDA event ID
- 94385
- Recalling firm
- Avanos Medical, Alpharetta, GA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 May 2024
- FDA classified
- 23 Jul 2024
- Reported
- 31 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 31 May 2024 | Recall initiated by company | |
| 23 Jul 2024 | Classified by FDA | +53 days |
| 31 Jul 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.
Product as listed by the FDA
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).
Where it was distributed
Worldwide distribution - US Nationwide - There was also government and military distribution and the countries of Canada and Australia.
Questions about this recall
Why was it recalled?
The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.
Which lots are affected?
All lot numbers. UDI-DI numbers: 1. 0270-14: 00350770472171, 00350770472188, 00350770472195, 00350770472201, 00350770472225, 00350770472232, 00350770472249, 00350770472256, 00350770472263, 00350770472270, 00350770472287, 00350770472294, 00350770472300, 00350770472317, 00350770472331, 00350770472348, 00350770472355, 00350770472362, 00350770472379, 00350770472386, 00350770472393, 00350770472409, 00350770472423, 00350770472416, 00350770479231, 00350770479279, 00350770479262, 00350770479255, and 00350770479293; 2. 0270-16: 00350770954912, 00350770954929, 00350770954936, 00350770954943, 00350770954950, 00350770954967, 00350770954974, 00350770954981, 00350770954998, 00350770956350, 00350770956367, 00350770956374, 00350770956381, 00350770956398, 00350770956404, 00350770956411, 00350770956428, 00350770956435, 00350770956442, 00350770956459, 00350770956466, 00350770956473, 00350770956480, 00350770956497, 00350770479309, 00350770479316, 00350770479323, 00350770479385, and 00350770479354; 3. 0270-18: 00350770956503, 00350770956510, 00350770956527, 00350770956534, 00350770956541, 00350770956558, 00350770956565, 00350770956572, 00350770956589, 00350770956596, 00350770956602, 00350770956619, 00350770956626, 00350770956633, 00350770956640, 00350770956657, 00350770956664, 00350770956671, 00350770956688, 00350770479347, 00350770479330, 00350770479392, 00350770479408, 00350770479415, 00350770479422, and 00350770479439; 4. 0270-22: 00350770956695, 00350770956701, 00350770956718, 00350770956725, 00350770956732, 00350770956749, 00350770956756, 00350770956763, 00350770479446, 00350770479453, 00350770479460, 00350770479477, 00350770479484, and 00350770479491, 00350770479514; 5. 8270-14: 00350770470207, 00350770470238, 00350770470245, 00350770470320, 00350770470351, 00350770470368, 00350770470375, 00350770470382, 00350770470399, 00350770470405, 00350770470412, 00350770470429, 00350770470436, 00350770470450, 00350770470467, 00350770470474, 00350770470481, 00350770470498, 00350770470511, 00350770470528, 00350770470535, 00350770470542, 00350770470559, 00350770470566, 00350770479521, 00350770479538, 00350770479552, 00350770479576, 00350770479590, 00350770479613, and 00350770479637; 6. 8270-16: 00350770441719, 00350770441726, 00350770441733, 00350770440811, 00350770440828, 00350770440835, 00350770440842, 00350770440859, 00350770440866, 00350770440873, 00350770440880, 00350770440897, 00350770440903, 00350770440910, 00350770440927, 00350770440934, 00350770440941, 00350770440958 ,00350770440965, 00350770440972, 00350770440989, 00350770440996, 00350770441009, 00350770441016 00350770479545, 00350770479569, 00350770479583, 00350770479606, 00350770479620, 00350770479644, and 00350770479736; 7. 8270-18: 00350770441023, 00350770441030, 00350770441054, 00350770441061, 00350770441078, 00350770441085, 00350770441092, 00350770441108, 00350770441115, 00350770441139, 00350770441146, 00350770441153, 00350770441160, 00350770441177, 00350770441184, 00350770441191, 00350770441214, 00350770441221, 00350770441238, 00350770479712, 00350770479699, 00350770479675, 00350770479651, 00350770479668, 00350770479682, and 00350770479705; 8. 8270-22: 00350770441245, 00350770441252, 00350770441269, 00350770441276, 00350770441283, 00350770441290, 00350770441429, 00350770441436, 00350770479729, 00350770479743, 00350770479750, 00350770479767, 00350770479774, 00350770479781, and 00350770479798.
Where was it sold?
Worldwide distribution - US Nationwide - There was also government and military distribution and the countries of Canada and Australia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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