Browse Device Recalls
3,528 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,528 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 3,528 FDA device recalls — Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 7, 2026 | Atlan A350. Model Number: 8211500. anesthesia workstation | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use o... | Class I | Draeger, Inc. |
| May 7, 2026 | Atlan A350XL. Model Number: 8621600. anesthesia workstation | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use o... | Class I | Draeger, Inc. |
| May 6, 2026 | Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Materia... | These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufactur... | Class I | B Braun Medical Inc |
| May 6, 2026 | Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 | Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the... | Class I | Fresenius Kabi USA, LLC |
| May 6, 2026 | LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005. | Potential software anomaly that can cause the pump to report a false battery-health value (typica... | Class I | Fresenius Kabi USA, LLC |
| May 6, 2026 | Spinal Needle procedure kits: Material Description (Material Number) 24GA.... | These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufactur... | Class I | B Braun Medical Inc |
| May 6, 2026 | Spinocan Spinal Needle procedure kits: Material Description (Material Numbe... | These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufactur... | Class I | B Braun Medical Inc |
| May 4, 2026 | Pediatric care bed; Product Designation: KayserBett IDA; | If the adjustment functions of the hand control, as instructed in the Manual, are not locked with... | Class I | KAYSERBETTEN GMBH & CO. KG |
| Apr 27, 2026 | BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 ... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| Apr 27, 2026 | BD¿Spinal Tray with BD¿Whitacre Needle 24 G x 3.5 in.; lidocaine HCL (1%), 5 ... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| Apr 27, 2026 | BD¿Spinal Tray with BD¿Quincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 m... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| Apr 27, 2026 | BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 2 ... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| Apr 27, 2026 | BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in., BD¿Quincke Needle 22 G... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| Apr 27, 2026 | BD¿Spinal Tray with BD¿Quincke Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 m... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| Apr 27, 2026 | BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 ... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| Apr 27, 2026 | BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 ... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| Apr 27, 2026 | BD¿Spinal Tray with BD¿Quincke Needle 26 G x 3.5 in.; lidocaine HCL (1%), 5 m... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| Apr 27, 2026 | BD¿Spinal Tray with BD¿Whitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 ... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| Apr 22, 2026 | RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N... | Labeling update concerning proximal clasp disconnection from the outer control tube which may pre... | Class I | Bolton Medical Inc. |
| 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 |
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.