CLASS I ONGOING Device recall · Reported 13 Mar 2024 · FDA Enforcement Report

MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors recalled

Avanos Medical is recalling MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding, distributed nationwide in the US. The recall was initiated on 16 Jan 2024 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesa) 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

Quantity recalled10808 units

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-1186-2024
FDA event ID: 93907
Recalling firm: Avanos Medical, Alpharetta, GA
Classification: Class I
Status: Ongoing
Recall initiated: 16 Jan 2024
FDA classified: 1 Mar 2024
Reported: 13 Mar 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

16 Jan 2024	Recall initiated by company
1 Mar 2024	Classified by FDA	+45 days
13 Mar 2024	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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 I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

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.

Other products in this recall event

1 other product · FDA event 93907

Reported	Class	Recall	Company	Reason	Where
13 Mar 2024	CLASS I	MIC* Gastric-Jejunal Feeding Tube recalled by Avanos Medical	Avanos Medical	Sterility	Nationwide

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