Browse Device Recalls

3,664 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,664 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 3,664 FDA device recalls, Class I.

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DateProductReasonClassFirm
Apr 21, 2026 Description/REF: PARACENTESIS KIT/ASK-00376-JHH Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... Class I ARROW INTERNATIONAL, LLC
Apr 21, 2026 Description/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT:... Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... Class I ARROW INTERNATIONAL, LLC
Apr 21, 2026 Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-15122-F, AHDC KIT... Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... Class I ARROW INTERNATIONAL, LLC
Apr 21, 2026 Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDUR... Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... Class I ARROW INTERNATIONAL, LLC
Apr 21, 2026 Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC; PI JACC K... Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... Class I ARROW INTERNATIONAL, LLC
Apr 20, 2026 Automated Impella Controller (AIC); Product Code: 0042-0000-US; A retrospective review identified that there are AIC units requiring specific hardware updates to... Class I Abiomed, Inc.
Apr 10, 2026 Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP,... Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, U... Class I Medline Industries, LP
Apr 10, 2026 Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP,... Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, U... Class I Medline Industries, LP
Apr 10, 2026 Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP,... Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, U... Class I Medline Industries, LP
Apr 10, 2026 Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP,... Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, U... Class I Medline Industries, LP
Apr 10, 2026 Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP,... Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, U... Class I Medline Industries, LP
Apr 10, 2026 Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP,... Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, U... Class I Medline Industries, LP
Apr 10, 2026 Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP,... Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, U... Class I Medline Industries, LP
Apr 10, 2026 Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-153... 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in i... Class I ARROW INTERNATIONAL, LLC
Apr 10, 2026 NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232... 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in i... Class I ARROW INTERNATIONAL, LLC
Apr 10, 2026 Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I,... 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in i... Class I ARROW INTERNATIONAL, LLC
Apr 10, 2026 Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-1519... 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in i... Class I ARROW INTERNATIONAL, LLC
Apr 2, 2026 Custom Convenience Kit containing recalled Medline Namic Angiographic Control... Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to ... Class I Windstone Medical Packaging, Inc.
Apr 2, 2026 Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G... Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may ... Class I Cook Incorporated
Apr 2, 2026 Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G... Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may ... Class I Cook Incorporated
Apr 2, 2026 Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 C... Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may ... Class I Cook Incorporated
Mar 27, 2026 AIDBAGs are first aid kits of convenience composed of individually labeled de... Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has b... Class I North American Rescue LLC.
Mar 25, 2026 Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number ... Potential for mislabeled syringe produced by the i.v.STATION device. Class I Omnicell, Inc.
Mar 25, 2026 VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000 Respiratory system intended to provide continuous/intermittent ventilator support, may not have b... Class I Ventec Life Systems, Inc.
Mar 24, 2026 Medline medical convenience kits, containing Namic Manifold, Labeled as: 1... Medline has identified the presence of particulate within the fluid path of the Manifolds. Class I Medline Industries, LP
Mar 24, 2026 Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extrav... Medline has identified the presence of particulate within the fluid path of the Manifolds. Class I Medline Industries, LP
Mar 24, 2026 Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Car... Medline has identified the presence of particulate within the fluid path of the Manifolds. Class I Medline Industries, LP
Mar 24, 2026 Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Car... Medline has identified the presence of particulate within the fluid path of the Manifolds. Class I Medline Industries, LP
Mar 24, 2026 Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Car... Medline has identified the presence of particulate within the fluid path of the Manifolds. Class I Medline Industries, LP
Mar 24, 2026 1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS-LEFT HEART,K... Medline has identified the presence of particulate within the fluid path of the Manifolds. Class I Medline Industries, LP
Mar 24, 2026 1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, ... Medline has identified the presence of particulate within the fluid path of the Manifolds. Class I Medline Industries, LP
Mar 24, 2026 Medline medical convenience kits, containing Namic Manifold, Labeled as: 1... Medline has identified the presence of particulate within the fluid path of the Manifolds. Class I Medline Industries, LP
Mar 24, 2026 Medline medical convenience kits, containing Namic Manifold, Labeled as: TAV... Medline has identified the presence of particulate within the fluid path of the Manifolds. Class I Medline Industries, LP
Mar 24, 2026 Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extrav... Medline has identified the presence of particulate within the fluid path of the Manifolds. Class I Medline Industries, LP
Mar 24, 2026 Medline medical convenience kits, containing Namic Manifold, Labeled as: HEA... Medline has identified the presence of particulate within the fluid path of the Manifolds. Class I Medline Industries, LP
Mar 19, 2026 Convenience kits containing Medline Namic Angiographic Control Syringes with ... Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwin... Class I American Contract Systems Inc
Mar 19, 2026 Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Car... Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE"... Class I Boston Scientific Corporation
Mar 19, 2026 Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VA... Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE"... Class I Boston Scientific Corporation
Mar 19, 2026 B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model ... Potential for the accumulation of small air bubbles in the arterial line due to adherence of bloo... Class I B Braun Medical Inc
Mar 19, 2026 B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Mod... Potential for the accumulation of small air bubbles in the arterial line due to adherence of bloo... Class I B Braun Medical Inc
Mar 19, 2026 B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Mode... Potential for the accumulation of small air bubbles in the arterial line due to adherence of bloo... Class I B Braun Medical Inc
Mar 19, 2026 B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Numb... Potential for the accumulation of small air bubbles in the arterial line due to adherence of bloo... Class I B Braun Medical Inc
Mar 19, 2026 B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. M... Potential for the accumulation of small air bubbles in the arterial line due to adherence of bloo... Class I B Braun Medical Inc
Mar 19, 2026 B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Mod... Potential for the accumulation of small air bubbles in the arterial line due to adherence of bloo... Class I B Braun Medical Inc
Mar 17, 2026 Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, R... Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting... Class I Medical Action Industries, Inc. 306
Mar 13, 2026 Halyard PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a l... Class I AVID Medical, Inc.
Mar 13, 2026 Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a l... Class I AVID Medical, Inc.
Mar 13, 2026 Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a l... Class I AVID Medical, Inc.
Mar 13, 2026 Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a l... Class I AVID Medical, Inc.
Mar 13, 2026 Halyard CATH LAB kit. Model Number: SACL75AM. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a l... Class I AVID 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.