Data / Medical devices / United States / Avanos Medical, Inc.
Avanos Medical, Inc.: FDA-registered device maker in Alpharetta, GA, United States, 107 510(k) clearances and 1 PMA approval
Avanos Medical, Inc. is registered with the FDA (registration 3011270181) in Alpharetta, GA, United States. It lists 61 device types. The FDA files 107 510(k) clearances and 1 PMA approval under its listings, the newest dated January 31, 2025. 48 recall events name it as the recalling firm (5 Class I). Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3011270181
- Address
- 5405 Windward Parkway, Alpharetta, GA, United States, 30004
- Owner or operator
- Avanos Medical, Inc. (2022573)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- January 23, 1995
- Registered through
- 2026
- Brand names listed
- 220266MIL, 220316, 220342, 220343, 220344, 220404, 220405, 220451 and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 107.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 31, 2025 | K243572 | Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04); Game Ready Full Leg Boot Wrap - Large (590922-04); Game Ready C-T Spine Wrap (590502-04); Game Ready Half Leg Boot (590906-04); Game Ready Back Wrap (590500-04); Game Ready Hand/Wrist Wrap (590811-04); Game Ready Flexed Elbow Wrap (590903-04); Game Ready Straight Elbow Wrap (590200-04); Game Ready Shoulder Wrap, Medium, Right (590422-04); Game Ready Shoulder Wrap, La | IRP | Substantially Equivalent | Avanos Medical, Inc. | accessdata.fda.gov |
| October 25, 2024 | K241185 | CORGRIP* SR NG/NI Tube Retention System | KNT | Substantially Equivalent | Avanos Medical, Inc. | accessdata.fda.gov |
| August 14, 2024 | K242057 | COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R) | GXD | Substantially Equivalent | Avanos Medical, Inc. | accessdata.fda.gov |
| June 6, 2024 | K240965 | CORTRAK* 2 Enteral Access System (20-0950) | KNT | Substantially Equivalent | Avanos Medical, Inc. | accessdata.fda.gov |
| April 22, 2022 | K220588 | Avanos* CORTRAK* 2 Enteral Access System (EAS) | KNT | Substantially Equivalent | Avanos Medical, Inc. | accessdata.fda.gov |
| December 22, 2020 | K203066 | COOLIEF Cooled Radiofrequency Kit Advanced | GXI | Substantially Equivalent | Avanos Medical, Inc. | accessdata.fda.gov |
| February 21, 2020 | K192491 | Coolief Radiofrequency Generator (CRG) System | GXD | Substantially Equivalent | Avanos Medical, Inc. | accessdata.fda.gov |
| October 29, 2019 | K192114 | Game Ready GRPro 2.1 System | IRP | Substantially Equivalent | Cool Systems, Inc. (Dba Game Ready) | accessdata.fda.gov |
| June 4, 2019 | K191340 | CORTRAK* 2 Equilateral Enteral Access System | KNT | Substantially Equivalent | Avanos Medical, Inc. | accessdata.fda.gov |
| April 30, 2019 | K183540 | Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL) | PNR | Substantially Equivalent | Neomed, Inc. | accessdata.fda.gov |
| March 22, 2019 | K181360 | ON-Q* Pump with Bolus | MEB | Substantially Equivalent | Halyard Health | accessdata.fda.gov |
| January 26, 2018 | K173955 | Mic-Key* SF Over-the-Wire Stoma Measuring Device | KNT | Unknown | Halyard Health, Inc. | accessdata.fda.gov |
| September 29, 2017 | K171685 | Med4 Elite | IRP | Substantially Equivalent | Cool Systems, Inc. (Dba Game Ready) | accessdata.fda.gov |
| August 29, 2017 | K162165 | ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump | MEA | Substantially Equivalent | Summit Medical Products, Inc. | accessdata.fda.gov |
| April 13, 2017 | K163461 | Coolief* Cooled RF Probe | GXI | Substantially Equivalent | Halyard Health, Inc. | accessdata.fda.gov |
| March 22, 2017 | K161979 | ENFit enteral syringe | PNR | Substantially Equivalent | Jiangyin Caina Technology Co., Ltd. | accessdata.fda.gov |
| December 16, 2016 | K163236 | COOLIEF Cooled Radiofrequency Kit | GXI | Substantially Equivalent | Halyard Health, Inc. | accessdata.fda.gov |
| December 5, 2016 | K162048 | EZstim*III Peripheral Nerve Stimulator/Nerve Locator | KOI | Substantially Equivalent | Halyard Health - Irvine | accessdata.fda.gov |
| September 30, 2016 | K161232 | ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit | BSO | Substantially Equivalent | Halyard Health | accessdata.fda.gov |
| September 15, 2016 | K162110 | CORGRIP NG/NI Tube Retention System | KNT | Unknown | Corpak Medsystems, Inc. A Division of Haylard Health | accessdata.fda.gov |
| June 17, 2016 | K161039 | NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL) | PNR | Substantially Equivalent | Neomed, Inc. | accessdata.fda.gov |
| December 17, 2015 | K152857 | NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps | PNR | Substantially Equivalent | Neomed, Inc. | accessdata.fda.gov |
| December 2, 2014 | K143164 | ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set | BSO | Substantially Equivalent | Kimberly-Clark Corporation | accessdata.fda.gov |
| November 20, 2014 | K142012 | FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS | PIF | Substantially Equivalent | Corpak Medsystems | accessdata.fda.gov |
| July 10, 2014 | K140658 | THERMOGARD DISPERSIVE ELECTRODES, THERMOGARD PLUS ABC DISPERSIVE ELECTRODES | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| March 26, 2014 | K133599 | CORGRIP | KNT | Substantially Equivalent | Corpak Medsystems | accessdata.fda.gov |
| February 3, 2014 | K131249 | ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES | MEB | Substantially Equivalent | I-Flow, LLC | accessdata.fda.gov |
| June 26, 2013 | K122653 | MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES | KNT | Unknown | Kimberly-Clark Corporation | accessdata.fda.gov |
| September 20, 2012 | K122373 | NEOMED ORAL/ENTERAL SYRINGE | FMF | Substantially Equivalent | Neomed, Inc. | accessdata.fda.gov |
| May 11, 2012 | K113333 | KIMBERLY-CLARK KIM VENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS | BTR | Substantially Equivalent | Kimberly-Clark Corporation | accessdata.fda.gov |
| April 19, 2012 | K120182 | NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES | KNT | Substantially Equivalent | Neomed, Inc. | accessdata.fda.gov |
| January 10, 2012 | K113351 | CORTRAK ENTERAL ACCESS DEVICE | KNT | Substantially Equivalent | Corpak Medsystems | accessdata.fda.gov |
| September 16, 2011 | K111355 | ECHOBRIGHT | CAZ | Substantially Equivalent | Life-Tech, Inc. | accessdata.fda.gov |
| January 13, 2011 | K102460 | AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH | BSO | Substantially Equivalent | Summit Medical Products, Inc. | accessdata.fda.gov |
| December 22, 2010 | K102007 | PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC, | CAZ | Substantially Equivalent | Life-Tech, Inc. | accessdata.fda.gov |
| August 3, 2010 | K100288 | NEOMED ENTERAL ONLY EXTENSION SET | KNT | Substantially Equivalent | Neomed, Inc. | accessdata.fda.gov |
| June 24, 2010 | K093662 | ECHOBRIGHT | CAZ | Substantially Equivalent | Life-Tech, Inc. | accessdata.fda.gov |
| June 14, 2010 | K100366 | MEDICINA ENTERAL FEEDING TUBES AND ACCESSORIES MODEL MGX/YY | KNT | Substantially Equivalent | Maxter Catheters | accessdata.fda.gov |
| April 22, 2010 | K100526 | AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE | FPD | Substantially Equivalent | Kentec Medical, Inc. | accessdata.fda.gov |
| December 8, 2009 | K093312 | KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL ACCESS DILATION SYSTEM | KGC | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| December 29, 2008 | K083210 | CORFLO ANTI IV ENTERAL FEEDING TUBE | FPD | Substantially Equivalent | Corpak Medsystems | accessdata.fda.gov |
| October 24, 2008 | K082923 | PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C | CAC | Substantially Equivalent | Life-Tech, Inc. | accessdata.fda.gov |
| October 1, 2008 | K082238 | NEOMED POLYURETHANE FEEDING TUBE | FPD | Substantially Equivalent | Neomed, Inc. | accessdata.fda.gov |
| September 25, 2008 | K081864 | PROLONG | BSP | Substantially Equivalent | Life-Tech, Inc. | accessdata.fda.gov |
| April 22, 2008 | K080821 | MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE | BTR | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| April 22, 2008 | K073187 | PERIPHERAL NERVE BLOCK SUPPORT TRAY | CAZ | Substantially Equivalent | Life-Tech, Inc. | accessdata.fda.gov |
| February 26, 2008 | K080253 | KIMBERLY-CLARK INTRODUCER KITS | KGC | Unknown | Kimberly-Clark Corp. | accessdata.fda.gov |
| January 9, 2008 | K072881 | NEOMED Enteral FEEDING TUBE | FPD | Substantially Equivalent | Neomed, Inc. | accessdata.fda.gov |
| December 19, 2007 | K072997 | NEOMED URINARY CATHETER | EZD | Substantially Equivalent | Neomed, Inc. | accessdata.fda.gov |
| December 19, 2007 | K072478 | BAYLIS PAIN MANAGEMENT GENERATOR-TD, MODELS: PMG-115-TD AND PMG-230-TD | GEI | Substantially Equivalent | Baylis Medical Co., Inc. | accessdata.fda.gov |
| October 18, 2007 | K072050 | PROLONG-EX, MODELS: PLEX-50CS, PLEX-100CS, PLEX-150CS | BSO | Substantially Equivalent | Life-Tech, Inc. | accessdata.fda.gov |
| July 19, 2007 | K071745 | BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE | GXI | Substantially Equivalent | Baylis Medical Co., Inc. | accessdata.fda.gov |
| May 24, 2007 | K070801 | IMM HYPODERMIC NEEDLE SET | FPA | Substantially Equivalent | Innovative Medical Manufacturing Co. | accessdata.fda.gov |
| January 26, 2007 | K063530 | ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP | MEB | Substantially Equivalent | I-Flow Corp. | accessdata.fda.gov |
| January 8, 2007 | K062937 | TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU | GXI | Substantially Equivalent | Baylis Medical Co., Inc. | accessdata.fda.gov |
| November 21, 2006 | K063234 | ON-Q INTRODUCERS | BSO | Substantially Equivalent | I-Flow Corp. | accessdata.fda.gov |
| December 8, 2005 | K052221 | AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP | FRN | Substantially Equivalent | Sorenson Medical, Inc. | accessdata.fda.gov |
| November 30, 2005 | K053082 | BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6 | GXI | Substantially Equivalent | Baylis Medical Co., Inc. | accessdata.fda.gov |
| November 30, 2005 | K051401 | ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER | BSO | Substantially Equivalent | I-Flow Corp. | accessdata.fda.gov |
| September 9, 2005 | K052117 | I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP) | MEB | Substantially Equivalent | I-Flow Corp. | accessdata.fda.gov |
| June 30, 2005 | K050803 | PEDIATRIC CUFFED AND UNCUFFED ET TUBES; STANDARD CUFFED AND UNCUFFED ET TUBES | BTR | Substantially Equivalent | Vitaid, Ltd. | accessdata.fda.gov |
| May 17, 2005 | K050499 | PROBLOC, HN SERIES AND PROLONG, PL SERIES | BSP | Substantially Equivalent | Life-Tech, Inc. | accessdata.fda.gov |
| January 11, 2005 | K043456 | MODIFICATION TO SOAKER CATHETER | BSO | Substantially Equivalent | I-Flow Corp. | accessdata.fda.gov |
| December 10, 2004 | K043114 | KIMBERLY-CLARK MIC-KEY LOW PROFILE GASTROSTOMY TUBE | KNT | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| November 6, 2003 | K033325 | AMBIT CONTINUOUS AMBULATORY INFUSION PUMP | FRN | Substantially Equivalent | Sorenson Medical, Inc. | accessdata.fda.gov |
| September 11, 2003 | K031951 | TRANSDISCAL SYSTEM (TRANSDISCAL PROBE), MODEL TDP-17-150-6 | GEI | Substantially Equivalent | Baylis Medical Co., Inc. | accessdata.fda.gov |
| July 17, 2003 | K031950 | BAYLIS PAIN MANAGEMENT GENERATOR, MODELS PMG-115-TD AND PMG-230-TD | GEI | Substantially Equivalent | Baylis Medical Co., Inc. | accessdata.fda.gov |
| March 31, 2003 | K030721 | QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE | LRO | Substantially Equivalent | Ballard Medical Products | accessdata.fda.gov |
| March 17, 2003 | K024190 | FENESTRATED INFUSION CATHETER | FRN | Substantially Equivalent | Promedic, Inc. | accessdata.fda.gov |
| May 3, 2002 | K020354 | BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL) | GXD | Substantially Equivalent | Baylis Medical Co., Inc. | accessdata.fda.gov |
| October 23, 2000 | K002389 | BAYLIS PAIN MANAGEMENT PROBE/PMP-20-145 AND BAYLIS PAIN MANAGEMENT CONNECTOR CABLE/PMX-BAY-BAY | GXI | Substantially Equivalent | Baylis Medical Co., Inc. | accessdata.fda.gov |
| August 23, 2000 | K002434 | PALM PUMP | MEA | Substantially Equivalent | Sorenson Medical, Inc. | accessdata.fda.gov |
| July 6, 2000 | K001129 | PROLONG, MODELS PL50, PL100, PL150 | CAZ | Substantially Equivalent | Life-Tech Intl., Inc. | accessdata.fda.gov |
| June 9, 2000 | K001287 | EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML | KPE | Substantially Equivalent | Sorenson Medical, Inc. | accessdata.fda.gov |
| March 28, 2000 | K000495 | BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES | BSP | Substantially Equivalent | Ballard Medical Products | accessdata.fda.gov |
| October 20, 1999 | K993138 | BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT | KNT | Substantially Equivalent | Ballard Medical Products | accessdata.fda.gov |
| March 4, 1999 | K984502 | NERVE BLOCK INFUSION KIT | MEB | Substantially Equivalent | I-Flow Corp. | accessdata.fda.gov |
| September 11, 1998 | K982894 | MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT | KNT | Substantially Equivalent | Ballard Medical Products | accessdata.fda.gov |
| July 17, 1998 | K972846 | BMC RF CANNULA | GXI | Substantially Equivalent | Baylis Medical Co., Inc. | accessdata.fda.gov |
| July 21, 1997 | K970178 | CLOG ZAPPER ENTERAL FEEDING TUBE DECLOGGING SYSTEM | KNT | Substantially Equivalent | Corpak, Inc. | accessdata.fda.gov |
| July 5, 1995 | K951533 | EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT | KDH | Substantially Equivalent | Ballard Medical Products | accessdata.fda.gov |
| May 30, 1995 | K941153 | EPI-SPINAL ANESTHESIA TRAY | CAZ | Unknown | Preferred Medical Products | accessdata.fda.gov |
| September 28, 1994 | K926581 | MIC TRANSGASTRIC JEJUNAL TUBE | KNT | Substantially Equivalent | Medical Innovations Corp. | accessdata.fda.gov |
| August 5, 1994 | K941464 | BASICS ENDOSCOPY SYSTEM | OCZ | Substantially Equivalent | Cox Medical Ent., Inc. | accessdata.fda.gov |
| May 26, 1994 | K941562 | 1ML LUER-LOK SYRINGE | FMF | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| May 2, 1994 | K921652 | MIC TRANSGASTRIC JEJUNAL FEEDING TUBE KIT | KNT | Unknown | Medical Innovations Corp. | accessdata.fda.gov |
| May 2, 1994 | K921370 | MIC GASTRO-ENTEROSTOMY TUBE MODIFICATION | KNT | Unknown | Medical Innovations Corp. | accessdata.fda.gov |
| April 29, 1994 | K940431 | TECNADYNE 20/20 FOG INHIBITOR KIT | GCJ | Substantially Equivalent | Tecnadyne Scientific, Inc. | accessdata.fda.gov |
| February 17, 1994 | K924065 | MIC PEG TUBE | KNT | Unknown | Medical Innovations Corp. | accessdata.fda.gov |
| January 28, 1994 | K932790 | THERMAL OPTION | KGE | Substantially Equivalent | Cox Medical Ent., Inc. | accessdata.fda.gov |
| December 1, 1993 | K922667 | MIC LOW PROFILE GASTROSTOMY TUBE | KNT | Unknown | Medical Innovations Corp. | accessdata.fda.gov |
| October 13, 1992 | K923671 | COX DISPOSABLE POLYPECTOMY SNARES | FDI | Substantially Equivalent | Cox Medical Ent., Inc. | accessdata.fda.gov |
| June 7, 1991 | K904440 | LOCAL PLEXUS BLOCK ANESTHESIA CATHETER KITS | CAZ | Substantially Equivalent | Preferred Medical Products | accessdata.fda.gov |
| December 21, 1989 | K894868 | WILTEK VARICES INJECTION NEEDLE | FBK | Substantially Equivalent | Wiltek Medical, Inc. | accessdata.fda.gov |
| May 31, 1989 | K892218 | ENDO-SPONGE | MNL | Substantially Equivalent | Endovations | accessdata.fda.gov |
| October 6, 1988 | K882199 | CLOTEST, CAMPYLOBACTER PYLORI UREASE ENZYME TEST | LYR | Substantially Equivalent | Auspharm Intl. , Ltd. | accessdata.fda.gov |
| September 21, 1988 | K882867 | CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE | KNT | Substantially Equivalent | Corpak Co. | accessdata.fda.gov |
| December 29, 1987 | K874004 | ALLIGATOR JAW GRASPING FORCEP (MODEL 23/125) | OCZ | Substantially Equivalent | Endovations | accessdata.fda.gov |
| February 20, 1986 | K860510 | NEONATE PERCUSSOR | BYI | Substantially Equivalent | Ballard Medical Products | accessdata.fda.gov |
| November 5, 1985 | K853253 | CORPAK FARRELL VALVE ENTERAL GASTRIC PRESSURE RELI | KNT | Substantially Equivalent | Corpak Co. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| November 13, 2017 | P160057 | TRIVISC | MOZ | 3 | May 20, 2025 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 30, 2026 | 98907 | Class II | Ongoing | Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-4320 | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | accessdata.fda.gov |
| March 19, 2025 | 96528 | Class I | Ongoing | Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Y-Adapter Component: No | Lack of sterility assurance for closed suction catheter systems | accessdata.fda.gov |
| May 31, 2024 | 94385 | Class II | Ongoing | 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 / | The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications. | accessdata.fda.gov |
| March 4, 2024 | 94518 | Class III | Ongoing | NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Amber NonSterile, Product Code BA-S05EO; b. 12mL Oral Syringe Amber NonSterile, Product Code BA-S12EO; c. 1mL Oral | The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers. | accessdata.fda.gov |
| January 16, 2024 | 93907 | Class I | Ongoing | 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 | MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist. | accessdata.fda.gov |
| October 13, 2023 | 93305 | Class II | Ongoing | 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 did contain DEHP. | accessdata.fda.gov |
| August 1, 2023 | 92852 | Class II | Completed | COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF channels to be activated individually or altogether. The system is controlled via a touch screen interf | Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults. | accessdata.fda.gov |
| April 24, 2023 | 92279 | Class II | Terminated | AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509 | Some of the ambIT kits were potentially distributed without an air in-line filter. | accessdata.fda.gov |
| February 3, 2023 | 91741 | Class II | Terminated | Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes: a) 12241, b) 12243, c) 12251 | Incorrect expiration date. | accessdata.fda.gov |
| February 3, 2023 | 91663 | Class I | Terminated | BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold. | Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient receiving inadequate ventilation. | accessdata.fda.gov |
| September 14, 2022 | 90964 | Class II | Terminated | Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1 Female Luer Lock, Labeled as: SUMMIT MEDICAL PRODUCTS, REF 220227; MPS Acacia CAT NO: BC-006-04; MEDICAL PRODUCTS SPECIALISTS EXTENSI | Sterile extension sets were distributed without an expiration date | accessdata.fda.gov |
| March 21, 2022 | 89997 | Class I | Terminated | Avanos Cortrak 2 Enteral Access System (EAS) | Product labeling is being modified. STOP using the Anonymous Account Mode feature of the CORTRAK 2 device immediately. CONFIRM placement of the NG/NI tube per institution protocol. | accessdata.fda.gov |
| December 22, 2021 | 89290 | Class II | Terminated | MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL | The External Retention Bolster contained in the kit may be a larger diameter than the tube. | accessdata.fda.gov |
| November 22, 2021 | 89132 | Class II | Terminated | BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for Multi-Access Port (MAP) Catheter; Sterile; Single Use | Product was distributed with incorrect expiration date. | accessdata.fda.gov |
| October 16, 2020 | 86634 | Class II | Terminated | CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector | Detachment of the Male AIV Adaptor from the Y-Connector. | accessdata.fda.gov |
| July 29, 2020 | 86244 | Class II | Terminated | AVANOS MIC-KEY SF Gastrostomy Feeding Tube | Devices had cracked or detached from the feeding tube body | accessdata.fda.gov |
| March 16, 2020 | 85260 | Class II | Terminated | CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit | The CORFLO PEG tube may become blocked at the center of the adapter (occluded) potentially causing a procedure to delayed or aborted. | accessdata.fda.gov |
| November 5, 2019 | 84227 | Class II | Terminated | Haylard Closed Suction System for Neonates/Pediatrics, 5 Fr, 1. REF 195, Y-Adapter, SAP Finished Product Code 109382303; 2. REF 201, with BALLARD Technology, SAP Finished Product Code 109382803; 3. REF 202, Elbow, SAP Fi | Avanos Medical has received reports stating that the central lumen of some 5 Fr Neonate/Pediatric Closed Suction Catheters may be fully blocked or partially blocked. This may cause the closed suction catheters (CSCs) to inadequately suction secretions and/or saline fluids form the patient's airway to prevent oxygen desaturation. | accessdata.fda.gov |
| October 8, 2019 | 84021 | Class II | Terminated | CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit. 2 units per case The devices could be branded as Halyard Health. | The connector piece to the PEG tube does not pass over the guidewire. | accessdata.fda.gov |
| October 24, 2018 | 81452 | Class III | Terminated | NEOCONNECT, Enteral Extension with ENFit connector, REF EXT-60NC The NeoMed NeoConnect Enteral Only Extension Set is intended for use as an extension set for nasogastric/oralgastric or gastric tube enteral feeding tubes, | The sterile pouch label states the expiration date is 2016-11-19, but the correct expiration date is 2019-11-09. The case label and the shipper label have the correct date | accessdata.fda.gov |
| June 4, 2018 | 81116 | Class II | Terminated | NeoMed Enteral Feeding Tubes with Enteral Only Connectors, French sizes 4.0Fr, 5.0Fr, 6.5Fr, 8.0Fr, and lengths 40cm, 60cm, 90cm. The product consists of a polyurethane feeding tube with an attached hub and tethered plug | Potential for the tethered plug on the hub of the NeoMed Enteral Feeding Tubes with Enteral Only Connectors to inadvertently open after closure. | accessdata.fda.gov |
| February 7, 2018 | 79531 | Class II | Terminated | Halyard Closed Suction System for Adults, Double Swivel Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway. Labeled as the following: a. HALYARD* 12FR DSE 21.3IN/54CM (WHITE); b. HALYARD* 1 | Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use. | accessdata.fda.gov |
| December 13, 2017 | 79479 | Class II | Terminated | CORTRAK* 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes with Electromagnetic Transmitting Stylet and CORFLO* Enteral Feeding tube, ANTI-IV* Connector, 10 Fr, 140 cm The device is used in patients that require intermi | The transmitting stylet within CORTRAK* 2 nasogastric/Nasointestinal (NG/NI) Feeding Tubes with ANTI-IV* connector (Product Code 20-9551Trak2A) may be visible within the window of the exit port of the feeding tube. Based on specifications, the transmitting stylet in the NG tube should not be visible within the port window. | accessdata.fda.gov |
| October 6, 2017 | 78391 | Class II | Terminated | Halyard Closed Suction System for Adults with BALLARD Technology WET PAK. 12 saline vials per kit, 20 kits per case. | Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents. | accessdata.fda.gov |
| February 3, 2017 | 76465 | Class II | Terminated | CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 12FR (4mm); Product Usage: CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adapter is the conne | Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress. | accessdata.fda.gov |
| November 9, 2016 | 75683 | Class II | Terminated | Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile), Product Code 44965 NS; C-Section Drape with Clear Screen and Full Incise (Sterile), Product Code 44966 00; C-Section Drape with Clear Screen (Non-S | Drapes within the affected lots may include a manufacturing variation that prevents convenient removal of the coated release paper, which inhibits easy access to the surgical site. | accessdata.fda.gov |
| June 16, 2016 | 74553 | Class II | Terminated | Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in nervous tissue. | Mismatch between the length of the RF electrode (probe) and the cannula (introducer) | accessdata.fda.gov |
| July 29, 2015 | 71966 | Class II | Terminated | KimVent* Closed Suction System for Adults, 12 F, T-Piece (Product Code 2155); KimVent* Closed Suction System for Adults, 14 F, T-Piece (Product Code 2205, 8169, 8248, 22015, 22025, 220125, 220135) A tracheobronchial suct | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position. | accessdata.fda.gov |
| April 14, 2015 | 71110 | Class II | Terminated | KimVent Turbo-Cleaning Closed Suction System for Adults, 10 F T-Piece (Product Code 227105); KimVent Turbo-Cleaning Closed Suction System for Adults, 12 F, DSE (Product Code 2271603); KimVent Turbo-Cleaning Closed Suctio | The internal blue flapper valve of certain KimVent Turbo-Cleaning Closed Suction System for Adults may have a potential defect. If present, the defect potentially allows air to leak out of the closed ventilator circuit. | accessdata.fda.gov |
| June 1, 2012 | 64826 | Class II | Terminated | I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective | I-Flow initiated two voluntary product removals of the ON-Q Pain Relief System: T-Block Needle/Catheter Tray and T-Block Needle/Catheter Kit because they may have potentially malfunctioned. | accessdata.fda.gov |
| May 8, 2012 | 62769 | Class I | Terminated | ON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND; ON-Q C-bloc with Select a Flow and ONDEMAND Model/Reference #: 7000180, 7000181, 7000182, 7000367, 7000397, CB003, CB005, CB006, P400X1-7+5/60, P400X2-14+5 | It was determined that in a small quantity of ON-Q pumps with ONDEMAND, the bolus button may not lock in the down position when depressed and/or the orange bolus refill indicator may stay in the lowermost position. As a result, the patient may receive continuous infusion at a rate greater than expected. | accessdata.fda.gov |
| January 26, 2012 | 61036 | Not yet classified | Terminated | CORFLO-Ultra Jejunal Tube with CORLOCK-Twoomey Y-Adaptor for use with the CORFLO-Max PEG; enteral feeding tube,10 Fr, 36" (91 cm), 3 Gram weighted bolus; individually packaged, 5 tubes per case; CORPAK MedSystems, Wheeli | The wrong size Twoomey adapter was packaged with the Jejunal tube. | accessdata.fda.gov |
| September 19, 2011 | 59969 | Not yet classified | Terminated | CORFLO 300 Enteral Pump; a volumetric rotary peristaltic intermittent enteral feeding pump; CORPAK MedSystems, Wheeling, IL 60090; catalog/reorder #20-0500. Intended to deliver formula to patients requiring tube feedings | Corpak is removing the Corflo 300 Enteral Pump from the market due to the possibility that with fluid ingress or other damage, the keypad may not function, and the possibility of motor mount failure. | accessdata.fda.gov |
| April 15, 2011 | 59148 | Not yet classified | Terminated | I-Flow ON-Q with Select-A-Flow Pumps, Intended for continuous and/or intermittent delivery of medication to and around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperati | The recall was initiated because I Flow became aware that a small percentage of ON-Q Pump with Select A Flow may develop a minor leak with a flow rate controller. There may be consequences for the patient, such as under delivery of pain medication or the need to prematurely remove the pump, which would result in loss of the pain treatment provided by the pum | accessdata.fda.gov |
| August 1, 2008 | 53080 | Not yet classified | Terminated | B. Braun Blistered Omnifix L.L. Syringe packaged in the Easypump LT 100-48, 100 ml x 2 ml/hr Used to provide an optional filling device for the Easypump. | I-Flow identified a B. Braun syringe package that had a tear/hole in the paper portion of the primary package. | accessdata.fda.gov |
| February 14, 2008 | 48454 | Not yet classified | Terminated | On-Q C-bloc 400 ml, 1-7 ml/hr Select-A-Flow + 5 ml/60 min ONDEMAND, REF CB005 indicated for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites | Two lots of ON-Q C-bloc, Model Number CB005 may contain an incorrect fill port label. | accessdata.fda.gov |
| February 12, 2008 | 48428 | Not yet classified | Terminated | ON-Q PainBuster Infusion Pump (270 ml, 5 ml/hr), REF PS6504, Part No. 5001260. The pump is indicated for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgica | The ON-Q PainBuster, REF PS6504 (lot number 772166), box may contain the wrong product, ON-Q PainBuster, REF PS6502. If the wrong product is used, patients would receive a 2 ml/hr infusion rather than a 5 ml/hr infusion, which could result in inadequate pain relief. | accessdata.fda.gov |
| February 11, 2008 | 50802 | Not yet classified | Terminated | I-Flow Corporation Easy Pump LT 60-24 (60 ml x 2 ml/hr), REF: 04434366, assembled in Mexico. The Easypump LT is indicated for continuous and/or intermittent infusion of medication for general infusion use, including anti | I-Flow Corporation received two complaints involving Easypump LT 60-24 (Lot 612996) containing a 100 ml x 2 ml/hr pump in the sterile package instead of a 60 ml x 2 ml/hr pump (Illustration was included to show consignee what both the correct and incorrect part looks like). Lot 612996 was manufactured on January 6, 2006. As of February 7, 2008, there have be | accessdata.fda.gov |
| March 27, 2007 | 44933 | Not yet classified | Terminated | ON-Q PainBuster with OnDemand (270 ml, 2 ml/hr + 5 ml bolus /60 min refill), Model PMB01, I-Flow Corporation, Lake Forest, CA 92630 U.S.A. | Misassembly: The ON-Q PainBuster PMB01 package may contain a Soaker catheter instead of a Non-Soaker catheter. As a result, the bolus button may remain latched in the down position which may cause the the device to deliver continuously at 7 ml/hr instead of 2 ml/hr. | accessdata.fda.gov |
| November 29, 2006 | 36984 | Not yet classified | Terminated | I-Flow ON-Q PainBuster (100 ml, 2 mI/hr) Pump, PM012, Lot #662449 and 662742 | The pump flow rate labeling may not match the package labeling. The label on filter may not match the label on the top of the pump or the package labeling. | accessdata.fda.gov |
| January 17, 2006 | 34494 | Not yet classified | Terminated | Easypump ST 100-1 infusion pump | The sterile pack may contain the wrong infusion pump inside. | accessdata.fda.gov |
| September 13, 2005 | 33407 | Not yet classified | Terminated | Stackhouse FreedomAire Lens/Hood; a sterile disposable protective head garment for use with the FreedomAire Surgical Helmet System, providing a clear plastic bubble lens and protective head hood to connect to the surgica | The packaging may be compromised such that sterility of the hoods cannot be guaranteed. | accessdata.fda.gov |
| September 10, 2003 | 27242 | Not yet classified | Terminated | Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; M | The exhalation hole in the sideport relief valve may be blocked, allowing excess pressure build-up. | accessdata.fda.gov |
| August 23, 2003 | 27936 | Not yet classified | Terminated | Easypump LT Elastomeric Infusion Pump (100 ml x 0.5 ml/hr) Part number: 5001120 | Some pumps run at 2 ml/hr instead of 0.5 ml/hr. | accessdata.fda.gov |
| March 18, 2003 | 25903 | Not yet classified | Terminated | Easypump LT 60-24 Easypump Infusion Pump (60 ml x 2 ml/hr) | Overinfusion due to misassembly. | accessdata.fda.gov |
| March 5, 2003 | 25777 | Not yet classified | Terminated | Paragon Administration Set (100 ml x 0.5 ml/hr) Part Number 5000936 | Wrong component may result in over infusion of medications. | accessdata.fda.gov |
| March 4, 2003 | 25779 | Not yet classified | Terminated | Homepump Eclipse Infusion Pump, Disposable Elastomeric Infusion System (100 ml x 50 ml/hr) Model E100500 Part No. 5001065 | Product infuses too fast at rate of 30 minutes instead of 2 hours. Component mix-up. | accessdata.fda.gov |
| August 19, 2002 | 27911 | Not yet classified | Terminated | Eclipse Infusion Pump, 250 ml X 250 ml per hour) Part 5001247 | Slower than expected infusion of medications, such as antibiotics. | accessdata.fda.gov |
Compare with other makers
- All makers of Tube, Gastro-Enterostomy
- All makers of Catheter, Conduction, Anesthetic
- All makers of Anesthesia Conduction Kit
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Clamp
- All makers of Tubes, Gastrointestinal (And Accessories)
Updated June 5, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.