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Browse Device Recalls

37 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 37 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 37 FDA device recalls.

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DateProductReasonClassFirm
Mar 19, 2025 Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... Lack of sterility assurance for closed suction catheter systems Class I Avanos Medical, Inc.
Mar 19, 2025 Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... Lack of sterility assurance for closed suction catheter systems Class I Avanos Medical, Inc.
Mar 19, 2025 Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... Lack of sterility assurance for closed suction catheter systems Class I Avanos Medical, Inc.
Mar 19, 2025 Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... Lack of sterility assurance for closed suction catheter systems Class I Avanos Medical, Inc.
Mar 19, 2025 Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... Lack of sterility assurance for closed suction catheter systems Class I Avanos Medical, Inc.
Mar 19, 2025 Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... Lack of sterility assurance for closed suction catheter systems Class I Avanos Medical, Inc.
Mar 19, 2025 Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... Lack of sterility assurance for closed suction catheter systems Class I Avanos Medical, Inc.
Mar 19, 2025 Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... Lack of sterility assurance for closed suction catheter systems Class I Avanos Medical, Inc.
May 31, 2024 MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement,... The IFU was missing some risk information requested by another country to be contained in the IFU... Class II Avanos Medical, Inc.
Mar 4, 2024 NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descrip... The expiration date was not printed on the outer shipping label, leading to expired syringes bein... Class III Avanos Medical, Inc.
Mar 4, 2024 NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descrip... The expiration date was not printed on the outer shipping label, leading to expired syringes bein... Class III Avanos Medical, Inc.
Mar 4, 2024 NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descrip... The expiration date was not printed on the outer shipping label, leading to expired syringes bein... Class III Avanos Medical, Inc.
Jan 16, 2024 MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: ... MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recall... Class I Avanos Medical, Inc.
Jan 16, 2024 MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric... MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recall... Class I Avanos Medical, Inc.
Oct 13, 2023 AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product cod... Certain lots of BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI were labeled as not bei... Class II Avanos Medical, Inc.
Aug 1, 2023 COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four i... Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing ... Class II Avanos Medical, Inc.
Apr 24, 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. Class II Avanos Medical, Inc.
Apr 24, 2023 SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568 Some of the ambIT kits were potentially distributed without an air in-line filter. Class II Avanos Medical, Inc.
Apr 24, 2023 ambIT Cassette Filter Male Luer, Product Code: 220266 Some of the ambIT kits were potentially distributed without an air in-line filter. Class II Avanos Medical, Inc.
Apr 24, 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. Class II Avanos Medical, Inc.
Apr 24, 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. Class II Avanos Medical, Inc.
Feb 3, 2023 Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes: a) 12241, b) 1224... Incorrect expiration date. Class II Avanos Medical, Inc.
Feb 3, 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 res... Class I Avanos Medical, Inc.
Feb 3, 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 res... Class I Avanos Medical, Inc.
Sep 14, 2022 Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Lue... Sterile extension sets were distributed without an expiration date Class II Avanos Medical, Inc.
Mar 21, 2022 Avanos Cortrak 2 Enteral Access System (EAS) Product labeling is being modified. STOP using the Anonymous Account Mode feature of the CORTRAK ... Class I Avanos Medical, Inc.
Dec 22, 2021 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. Class II Avanos Medical, Inc.
Dec 22, 2021 MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 F... The External Retention Bolster contained in the kit may be a larger diameter than the tube. Class II Avanos Medical, Inc.
Nov 22, 2021 BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement f... Product was distributed with incorrect expiration date. Class II Avanos Medical, Inc.
Nov 22, 2021 BALLARD* Multi-Access Port (MAP) Catheter, Double Swivel Y- Adult, 16 French;... Product was distributed with incorrect expiration date. Class II Avanos Medical, Inc.
Nov 22, 2021 BALLARD* Multi-Access Port Catheter, Double Swivel Y Elbow, Adult, 14 French;... Product was distributed with incorrect expiration date. Class II Avanos Medical, Inc.
Oct 16, 2020 CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector Detachment of the Male AIV Adaptor from the Y-Connector. Class II Avanos Medical, Inc.
Jul 29, 2020 AVANOS MIC-KEY SF Gastrostomy Feeding Tube Devices had cracked or detached from the feeding tube body Class II Avanos Medical, Inc.
Mar 16, 2020 CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit The CORFLO PEG tube may become blocked at the center of the adapter (occluded) potentially causin... Class II Avanos Medical, Inc.
Nov 5, 2019 Haylard Closed Suction System for Neonates/Pediatrics, 5 Fr, 1. REF 195, Y-... Avanos Medical has received reports stating that the central lumen of some 5 Fr Neonate/Pediatric... Class II Avanos Medical, Inc.
Oct 8, 2019 CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG... The connector piece to the PEG tube does not pass over the guidewire. Class II Avanos Medical, Inc.
Oct 8, 2019 CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG... The connector piece to the PEG tube does not pass over the guidewire. Class II Avanos Medical, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.