Avanos Medical, Inc. recalls MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx (Non-ENFIT); and MIC-KEY*…
The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.
Read the official notice →- Date
- 2024-07-31
- Country
- United States
- Brand
- Avanos Medical
- Product
- MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx (Non-ENFIT); and MIC-KEY*…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide - There was also government and…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Avanos Medical recalls
- 2026-06-17
USAvanos Medical, Inc. recalls Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-4320
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
- 2025-04-23
- US
Avanos Medical, Inc. recalls Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Software Version: N/A Product Description:…
Lack of sterility assurance for closed suction catheter systems
FDA · DeviceAvanos Medical, Inc.Worldwide - US Nationwide distribution including in the states of AL, AZ, CA,…Official notice → - 2024-06-19
- US
Avanos Medical, Inc. recalls NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a.0.5mL Oral Syringe Orange NonSterile, Product Code…
The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
FDA · DeviceAvanos Medical, Inc.Worldwide distribution - US Nationwide and the countries of Australia, New…Official notice → - 2024-03-13
- US
Avanos Medical, Inc. recalls MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector -…
MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.
FDA · DeviceAvanos Medical, Inc.Worldwide distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO,…Official notice → - 2023-11-29
- US
Avanos Medical, Inc. recalls AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation
Certain lots of BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI were labeled as not being made with Di(2-ethylhexyl) phthalate (DEHP); however, Avanos has determined that the tubing components of the product…
- 2023-09-27
- US
Avanos Medical, Inc. recalls COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF channels to be…
Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.
FDA · DeviceAvanos Medical, Inc.US Distribution to states of: AZ, CA, GA, IA, IN, KS, LA, MN, NC, NM, NY, OH,…Official notice →
Other drugs & medical recalls in the United States
- 2024-07-31
- US
Randox Laboratories Ltd. recalls RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers.…
Cystatin C Reagent marketed without a 510 (k)
FDA · DeviceRandox Laboratories Ltd.US Nationwide distribution in the states of AL, CA, GA, NY.Official notice → - US
Embecta Corp. recalls BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Counseling Sample Toolbox -Catalog 6484755/Lot Number:…
BD Nano 2nd Gen Pen Needle was shipped close to or after the labeled expiration date of February 29, 2024. Using a device past its expiry sterility and integrity of the device cannot be guaranteed.
- US
Medtronic Perfusion Systems recalls TourniKwik Tourniquet Set (CFN 79012)
Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.
FDA · DeviceMedtronic Perfusion SystemsWorldwide - US Nationwide distribution in the states of MN, MA, UT, CA, and…Official notice → - US
Securitas Healthcare LLC recalls Arial Call Station, Model Numbers CSK200-1069 and CSK200-1069MR, is a wireless nurse call station.
This is a risk that alarms will not be received by the Arial Wireless Nurse Call System and premature depletion of the battery.
FDA · DeviceSecuritas Healthcare LLCUS: FL, CA, AL, ND, MS, WA, MN, TX, OR, WI, MD, NY, NEOfficial notice → - US
Securitas Healthcare LLC recalls Arial Call Station, Model Numbers CSK200 and CSK200MR, is a wireless, battery-operated call device installed inside resident living…
There is a risk that alarms will not be received by the Arial Wireless Emergency Call System and premature depletion of the battery.
FDA · DeviceSecuritas Healthcare LLCUS: NE, MN, WA, MD, TX, ON, WI, OR, MS, CA, and CanadaOfficial notice → - US
Olympus Corporation of the Americas recalls ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation of…
Electrosurgical Generators ESG-410 does not power on upon use, may result in delays in initiating treatment or prolonged surgery