Home / Recalls / Avanos Medical, Inc. / Z-1186-2024

Z-1186-2024 Class I Ongoing

Recalled by Avanos Medical, Inc. — Alpharetta, GA

FDA device recall Z-1186-2024 was initiated by Avanos Medical, Inc. on Jan 16, 2024 and is designated Class I. Reason for recall: MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist. The recall status is ongoing. Affected quantity: 10808 units.

Recall Details

Product Type
Devices
Report Date
Mar 13, 2024
Initiation Date
Jan 16, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10808 units

Product Description

MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16; b) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-15; c) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-22; d) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-30; e) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 18 Fr, Product Code 8250-18; f) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 18 Fr, Product Code 8250-18-22; g) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 18 Fr, Product Code 8250-18-30; h) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 22 Fr, Product Code 8250-22; i) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Surgical Placement - 16 Fr, Product Code 8260-16; j) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Surgical Placement - 18 Fr, Product Code 8260-18; k) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Surgical Placement - 22 Fr, Product Code 8260-22

Reason for Recall

MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.

Distribution Pattern

Worldwide distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY including PR; and OUS (foreign) countries of: Canada, Colombia, Costa Rica, UAB, Israel, Kuwait, and Panama.

Code Information

a) Product Code 8250-16, UDI/DI 350770445410, Batch Numbers: 30180762, 30226671, 30226823, 30233440, 30238985, 30242039, 30254749, 30265005, 30266483, 30265374, 30268260, 30270862; b) Product Code 8250-16-15, UDI/DI 350770445427, Batch Numbers: 30226822, 30242228, 30253956; c) Product Code 8250-16-22, UDI/DI 00350770445434, Batch Numbers: 30184814, 30226821, 30247088, 30253955, 30262508, 30226820; d) Product Code 8250-16-30, UDI/DI 00350770445441, Batch Numbers: 30231400, 30238125 30247087, 30250300, 30258135, 30265373; e) Product Code 8250-18, UDI/DI 00350770445458, Batch Numbers: 30181846, 30184760, 30185381, 30226672, 30229833, 30233376, 30233439, 30235094, 30238124, 30238984, 30250140, 30251089, 30250169, 30254748, 30255675, 30256486, 80402128, 30259225, 30259566, 30261699, 30262040, 30264284, 30267593, 30268259, 30270505; f) Product Code 8250-18-22, UDI/DI 00350770445465, Batch Numbers: 30184824, 30228970, 30240302, 30247094, 30257066; g) Product Code 8250-18-30, UDI/DI 00350770445472, Batch Numbers: 30181900, 30226819, 30228969, 30240301, 30247092, 30252989, 30253953, 30259565, 30265004, 30265372, 30270861; h) Product Code 8250-22, UDI/DI 00350770445489, Batch Numbers: 30184759, 30185380, 30186750, 30221235, 30226670, 30226818, 30228968, 30238123, 30238475, 30238983, 30242226, 30242037, 30252072, 30252985, 30252998, 30255676, 30254747, 30256485, 30259224, 30262039, 30264283, 30267123, 30268258, 30270504, 30270860; i) Product Code 8260-16, UDI/DI 00350770445496, Batch Numbers: 30181845, 30223861, 30256484, 30290828; j) Product Code 8260-18, UDI/DI 00350770445502, Batch Numbers: 30185408, 30233438, 30242225, 30259226, 30264282, 30290830; k) Product Code 8260-22 UDI/DI 00350770445519, Batch Numbers: 30256483, 30259564, 30290829

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-1186-2024
openFDA file date
Oct 6, 2026
Loaded by RegDataLab
Oct 12, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it. FDA may have changed the recall since.

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FDA data resources