Chrysalis Intelligence · Sponsors · Avanos Medical, Inc.

Avanos Medical, Inc.

Alpharetta, GA, US · 7 510(k) clearances · 34 recalls (13 Class I)

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Total clearances
7
2020-02-21 → 2025-01-31
Last 12 months
0
Product codes
4
Most recent
2025-01-31
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
KNT Tubes, Gastrointestinal (And Accessories) Class II Gastroenterology, Urology 3 2024-10-25
GXD Generator, Lesion, Radiofrequency Class II Neurology 2 2024-08-14
IRP Massager, Powered Inflatable Tube Class II Physical Medicine 1 2025-01-31
GXI Probe, Radiofrequency Lesion Class II Neurology 1 2020-12-22
Safety

Recalls (34)

Class I (serious)
13
Risk of injury / death
Total recalls
34
Currently ongoing
15
Most recent
2025-03-19
DateSeverityStatusRecall # ProductCodeReason
2025-03-19 Class I Ongoing Z-1528-2025 Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Software Version: N/A Pr… — Lack of sterility assurance for closed suction catheter systems
2025-03-19 Class I Ongoing Z-1527-2025 Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 227-5 Software Version: N/A Product… — Lack of sterility assurance for closed suction catheter systems
2025-03-19 Class I Ongoing Z-1526-2025 Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2271418-5 Software Version: N/A Pro… — Lack of sterility assurance for closed suction catheter systems
2025-03-19 Class I Ongoing Z-1525-2025 Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2210-5 Software Version: N/A Produc… — Lack of sterility assurance for closed suction catheter systems
2025-03-19 Class I Ongoing Z-1524-2025 Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 220135 Software Version: N/A Produc… — Lack of sterility assurance for closed suction catheter systems
2025-03-19 Class I Ongoing Z-1523-2025 Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 20083 Software Version: N/A Product… — Lack of sterility assurance for closed suction catheter systems
2025-03-19 Class I Ongoing Z-1522-2025 Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 210 Software Version: N/A Product D… — Lack of sterility assurance for closed suction catheter systems
2025-03-19 Class I Ongoing Z-1521-2025 Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product D… — Lack of sterility assurance for closed suction catheter systems
2024-05-31 Class II Ongoing Z-2422-2024 MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx (Non-ENFIT… — The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.
2024-03-04 Class III Ongoing Z-2037-2024 NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a.0.5mL Oral Syringe Orange NonS… — The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
2024-03-04 Class III Ongoing Z-2036-2024 NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Blue NonSt… — The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
2024-03-04 Class III Ongoing Z-2035-2024 NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Amber NonS… — The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
2024-01-16 Class I Ongoing Z-1187-2024 MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: a) MIC* Gastric-Jejunal Feeding Tube Kit -… — MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.
2024-01-16 Class I Ongoing Z-1186-2024 MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connec… — MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.
2023-10-13 Class II Ongoing Z-0360-2024 AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on me… — 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…
2023-08-01 Class II Completed Z-2622-2023 COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF cha… — Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.
2023-04-24 Class II Terminated Z-1688-2023 ambIT Cassette Filter Male Luer, Product Code: 220266 — Some of the ambIT kits were potentially distributed without an air in-line filter.
2023-04-24 Class II Terminated Z-1687-2023 SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568 — Some of the ambIT kits were potentially distributed without an air in-line filter.
2023-04-24 Class II Terminated Z-1686-2023 SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537 — Some of the ambIT kits were potentially distributed without an air in-line filter.
2023-04-24 Class II Terminated Z-1685-2023 AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507 — Some of the ambIT kits were potentially distributed without an air in-line filter.
2023-04-24 Class II Terminated Z-1684-2023 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.
2023-02-03 Class II Terminated Z-1406-2023 Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes: a) 12241, b) 12243, c) 12251 — Incorrect expiration date.
2023-02-03 Class I Terminated Z-1190-2023 BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow 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 inadequa…
2023-02-03 Class I Terminated Z-1189-2023 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 inadequa…
2022-09-14 Class II Terminated Z-0195-2023 Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1 Female Luer Lock, Labeled as: S… — Sterile extension sets were distributed without an expiration date
2022-03-21 Class I Terminated Z-1032-2022 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 …
2021-12-22 Class II Terminated Z-0566-2022 MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL — The External Retention Bolster contained in the kit may be a larger diameter than the tube.
2021-12-22 Class II Terminated Z-0565-2022 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.
2021-11-22 Class II Terminated Z-0847-2022 BALLARD* Multi-Access Port (MAP) Catheter, Double Swivel Y- Adult, 16 French; Sterile; Single Use — Product was distributed with incorrect expiration date.
2021-11-22 Class II Terminated Z-0846-2022 BALLARD* Multi-Access Port Catheter, Double Swivel Y Elbow, Adult, 14 French; Sterile; Single Use — Product was distributed with incorrect expiration date.
2021-11-22 Class II Terminated Z-0845-2022 BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for Multi-Access Port (MAP) Catheter; Steril… — Product was distributed with incorrect expiration date.
2020-10-16 Class II Terminated Z-0540-2021 CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector — Detachment of the Male AIV Adaptor from the Y-Connector.
2020-07-29 Class II Terminated Z-2969-2020 AVANOS MIC-KEY SF Gastrostomy Feeding Tube — Devices had cracked or detached from the feeding tube body
2020-03-16 Class II Terminated Z-1822-2020 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.
Filings

All 510(k) clearances (7)

Date K-number Device Code Class Specialty
2025-01-31 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 Class II Physical Medicine
2024-10-25 K241185 CORGRIP* SR NG/NI Tube Retention System KNT Class II Gastroenterology, Urology
2024-08-14 K242057 COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R) GXD Class II Neurology
2024-06-06 K240965 CORTRAK* 2 Enteral Access System (20-0950) KNT Class II Gastroenterology, Urology
2022-04-22 K220588 Avanos* CORTRAK* 2 Enteral Access System (EAS) KNT Class II Gastroenterology, Urology
2020-12-22 K203066 COOLIEF Cooled Radiofrequency Kit Advanced GXI Class II Neurology
2020-02-21 K192491 Coolief Radiofrequency Generator (CRG) System GXD Class II Neurology
Data source: openFDA · Generated 2026-09-07 09:19 · Last ingest 2026-09-07T13:19:27.426703 · Pipeline: Chrysalis Intelligence