Browse Device Recalls
2,831 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,831 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 2,831 FDA device recalls in 2025.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 10, 2025 | Intact Vascular Tack Endovascular System, to treat vascular dissections with ... | Use of Tack Endovascular system, designed to treat acute dissections of inner wall or lining of a... | Class I | Spectranetics Corporation |
| Jan 10, 2025 | Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use ... | Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: ... | Class I | Fresenius Kabi USA, LLC |
| Jan 10, 2025 | Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Ge... | Potential that the induction seal is not completely sealed to the device tube packaging. | Class II | Integra LifeSciences Corp. |
| Jan 9, 2025 | Medline Convenience Kits for Various Procedures: 1) CLOVIS RESP/INTUB DRAWER... | Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jan 9, 2025 | A820 myPTM Software Application associated with Medtronic SynchroMed Pump and... | Product complaints were received describing the A820 myPTM app taking longer than expected for pa... | Class II | Medtronic Neuromodulation |
| Jan 9, 2025 | CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacteria... | The machine side connector of the filter HME may be occluded by plastic which prevents proper air... | Class II | Kung Shin Plastics Co. Ltd. |
| Jan 9, 2025 | Medline Convenience Kits for Various Procedures: 1) ADULT INTUBATION TRAY, M... | Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jan 9, 2025 | CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200... | The machine side connector of the filter HME may be occluded by plastic which prevents proper air... | Class II | Kung Shin Plastics Co. Ltd. |
| Jan 8, 2025 | stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating an... | Precision Thin blade attachments have a potential to be out of measurement specifications, preven... | Class II | Stryker Corporation |
| Jan 8, 2025 | (1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station ... | Labeling is insufficient regarding delays in access to medication. The firm is strengthening the ... | Class II | CareFusion 303, Inc. |
| Jan 8, 2025 | The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a ... | The MSOT Acuity Echo does not include an adequate instruction for safe operation of the device. T... | Class II | Ithera Medical Gmbh |
| Jan 8, 2025 | 139088-01 BD PYXIS MEDBANK MEDPASS MODULE 169-151 BD PYXIS MEDBANK MINI 1FH-2... | Labeling update to include a contraindication statement against the use of medicine cabinets in ... | Class II | CareFusion 303, Inc. |
| Jan 8, 2025 | 155288-01 BD PYXIS MEDBANK MINI 1FH-1FM 169-137 BD PYXIS MEDBANK MINI 1FH-1FM... | Labeling update to include a contraindication statement against the use of medicine cabinets in ... | Class II | CareFusion 303, Inc. |
| Jan 8, 2025 | 139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 100... | Labeling update to include a contraindication statement against the use of medicine cabinets in ... | Class II | CareFusion 303, Inc. |
| Jan 8, 2025 | 138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR... | Labeling update to include a contraindication statement against the use of medicine cabinets in ... | Class II | CareFusion 303, Inc. |
| Jan 8, 2025 | (1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS)... | Software issues could potentially result in: 1) delays in accessing dispensing software applicati... | Class II | CareFusion 303, Inc. |
| Jan 8, 2025 | stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating an... | Precision Thin blade attachments have a potential to be out of measurement specifications, preven... | Class II | Stryker Corporation |
| Jan 8, 2025 | The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the ... | Three lots of Rapid fFN Specimen Collection kit (901164, 901165, and 904850) contain Rapid fFN Sp... | Class II | Hologic, Inc. |
| Jan 6, 2025 | Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Ca... | Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omiss... | Class II | Sysmex America, Inc. |
| Jan 6, 2025 | NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D ... | It was identified internally that two commingle events occurred where the metal support post with... | Class II | Zimmer, Inc. |
| Jan 6, 2025 | NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F ... | It was identified internally that two commingle events occurred where the metal support post with... | Class II | Zimmer, Inc. |
| Jan 5, 2025 | VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Cathe... | Due to an observed trend of neurovascular events | Class I | Biosense Webster, Inc. |
| Jan 3, 2025 | Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000... | Their is a potential that implanted pulse generators may stop delivering therapy due to an intern... | Class II | LivaNova USA, Inc. |
| Jan 3, 2025 | Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/... | Their is a potential that implanted pulse generators may stop delivering therapy due to an intern... | Class II | LivaNova USA, Inc. |
| Jan 3, 2025 | Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenien... | Medline is recalling medical convenience kits which were assembled with specific Coloplast Foley ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jan 3, 2025 | Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer... | Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorr... | Class II | XTANT Medical Holdings, Inc |
| Jan 2, 2025 | Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socra... | Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch... | Class II | Scientia Vascular, Inc. |
| Jan 2, 2025 | Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI... | Disposable set may leak during priming from a female quick connector due to a crack in the female... | Class II | Belmont Instrument LLC |
| Jan 2, 2025 | Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and Uni... | Identified reagent lots are experiencing a high rate of calibration failures with failure code of... | Class II | Beckman Coulter Inc. |
| Jan 2, 2025 | ARTIS One Angiographic X-Ray System | A potential issue with ARTIS One systems was identified. In very rare situations, the first x-ra... | Class II | SIEMENS MEDICAL SOLUTIONS USA, INC |
| Jan 2, 2025 | Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK ... | Due to devices being irradiated above the established specification which my result in package in... | Class II | US Endodontics, LLC |
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.