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 |
|---|---|---|---|---|
| Mar 14, 2025 | Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners,... | Update to IFU to provide additional information related to risk with device over-rotation and mu... | Class II | Merit Medical Systems, Inc. |
| Mar 14, 2025 | Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038 | A potential weakness has been identified in the probe body, so that, in a specific production bat... | Class II | ESAOTE S.P.A. |
| Mar 14, 2025 | Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, Sterile... | Update to IFU to provide additional information related to risk with device over-rotation and mu... | Class II | Merit Medical Systems, Inc. |
| Mar 14, 2025 | DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002) | Potential of compromised compatibility resulting in influence on the positioning of the reference... | Class II | Pro-Med Instruments Gmbh |
| Mar 13, 2025 | HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 10775... | Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cau... | Class I | Thoratec LLC |
| Mar 13, 2025 | Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage... | The potential for risk of microbiological contamination of products due to inability to ensure st... | Class II | INSTITUT GEORGES LOPEZ |
| Mar 12, 2025 | Brand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Numb... | The potential for cracks forming in the breathing circuit hose. | Class I | Draeger, Inc. |
| Mar 12, 2025 | Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex... | The potential for cracks forming in the breathing circuit hose. | Class I | Draeger, Inc. |
| Mar 12, 2025 | Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex... | The potential for cracks forming in the breathing circuit hose. | Class I | Draeger, Inc. |
| Mar 12, 2025 | Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex... | The potential for cracks forming in the breathing circuit hose. | Class I | Draeger, Inc. |
| Mar 12, 2025 | Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex... | The potential for cracks forming in the breathing circuit hose. | Class I | Draeger, Inc. |
| Mar 12, 2025 | Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Refe... | Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test r... | Class II | Qiagen Sciences LLC |
| Mar 12, 2025 | Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex... | The potential for cracks forming in the breathing circuit hose. | Class I | Draeger, Inc. |
| Mar 12, 2025 | Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter ... | Due to manufacturing issues there is a potential for the catheter sheath to detach. | Class I | Conavi Medical Inc. |
| Mar 12, 2025 | Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: ... | The potential for cracks forming in the breathing circuit hose. | Class I | Draeger, Inc. |
| Mar 11, 2025 | BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-... | Users trying to restock a single bin location of an automated dispensing cabinet, during pocket e... | Class II | CareFusion 303, Inc. |
| Mar 11, 2025 | BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK... | Catheters indicated for short-or-long term access to the central venous system have tubing that e... | Class I | Bard Access Systems, Inc. |
| Mar 11, 2025 | BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYX... | Due to a software issue, when attempting to restock the automated dispensing cabinet, user have r... | Class II | CareFusion 303, Inc. |
| Mar 11, 2025 | Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN):... | Incorrect software flagging may occur for the assay that may potentially lead to an erroneous res... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 11, 2025 | BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD P... | Due to a software bug, automated dispensing cabinet is unable to calculate countback discrepancie... | Class II | CareFusion 303, Inc. |
| Mar 10, 2025 | NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; ... | Nerve Monitoring System with certain software versions has potential for increased stimulus artif... | Class II | Medtronic Xomed, Inc. |
| Mar 10, 2025 | Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System. | Potential for collimator to fall as a result of incorrect installation. | Class II | Philips North America Llc |
| Mar 10, 2025 | Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of ... | Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro ... | Class II | Maquet Cardiovascular, LLC |
| Mar 10, 2025 | Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System. | Potential for collimator to fall as a result of incorrect installation. | Class II | Philips North America Llc |
| Mar 8, 2025 | TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002; | The devices are missing the laser marked depth markings. | Class II | Straumann USA LLC |
| Mar 7, 2025 | PDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1 | Identified curing issues with the silicone during the needles manufacturing process. | Class II | Ethicon Endo Surgery, LLC |
| Mar 7, 2025 | ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH | Identified curing issues with the silicone during the needles manufacturing process. | Class II | Ethicon Endo Surgery, LLC |
| Mar 7, 2025 | PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM | Identified curing issues with the silicone during the needles manufacturing process. | Class II | Ethicon Endo Surgery, LLC |
| Mar 7, 2025 | PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP | Identified curing issues with the silicone during the needles manufacturing process. | Class II | Ethicon Endo Surgery, LLC |
| Mar 6, 2025 | Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number ... | The battery for certain ultrasound systems can potentially develop an internal failure which coul... | Class II | GE Medical Systems, LLC |
| Mar 6, 2025 | Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (... | The battery for certain ultrasound systems can potentially develop an internal failure which coul... | Class II | GE Medical Systems, LLC |
| Mar 6, 2025 | Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prot... | The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label. | Class II | Fisher Diagnostics |
| Mar 6, 2025 | Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage proth... | The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label. | Class II | Fisher Diagnostics |
| Mar 5, 2025 | stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, pack... | Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... | Class II | Tornier S.A.S. |
| Mar 5, 2025 | MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Sal... | Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 5, 2025 | stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Art... | Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... | Class II | Tornier S.A.S. |
| Mar 5, 2025 | stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE20... | Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... | Class II | Tornier S.A.S. |
| Mar 5, 2025 | stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Ste... | Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... | Class II | Tornier S.A.S. |
| Mar 5, 2025 | MEDLINE ReNewal Coblator II Evac 70 Xtra Plasma Wand,w/Integrated Saline Line... | Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 5, 2025 | MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey... | Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 5, 2025 | stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in... | Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... | Class II | Tornier S.A.S. |
| Mar 5, 2025 | MEDLINE ReNewal ENT Coblator II PROcise XP Wand,w/Integrated Cable Suction & ... | Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 5, 2025 | HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607 | Due to incorrect the battery charger being packaged and distributed. Product labeling does not m... | Class II | Advanced Bionics, LLC |
| Mar 5, 2025 | stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total... | Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... | Class II | Tornier S.A.S. |
| Mar 5, 2025 | stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total... | Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... | Class II | Tornier S.A.S. |
| Mar 5, 2025 | stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, pa... | Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... | Class II | Tornier S.A.S. |
| Mar 5, 2025 | stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packa... | Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... | Class II | Tornier S.A.S. |
| Mar 4, 2025 | Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm ... | product mix-up; Vascular stent labeled as one size but contains a different size. | Class II | Cordis US Corp |
| Mar 4, 2025 | Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Mod... | The impacted lots have a higher occurrence of invalid rates when compared to the product Instruct... | Class II | Abbott Diagnostics Scarborough, Inc. |
| Mar 4, 2025 | Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number:... | The impacted lots have a higher occurrence of invalid rates when compared to the product Instruct... | Class II | Abbott Diagnostics Scarborough, 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.