Browse Device Recalls
35,290 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,290 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 35,290 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 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 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, 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 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 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 | 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 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 | 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 | 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 | Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 2... | 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. |
| Mar 4, 2025 | InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MM... | Insulin pens may have been incorrectly assembled therefore users could experience the following: ... | Class II | Medtronic MiniMed, Inc. |
| 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. |
| Mar 4, 2025 | Stimulation RC Clinician Programmer Application, Model A71400, when used with... | There is a software issue that can permanently disable communication with an implantable neurosti... | Class II | Medtronic Neuromodulation |
| 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 Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 2... | 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 | Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm ... | product mix-up; Vascular stent labeled as one size but contains a different size. | Class II | Cordis US Corp |
| Mar 3, 2025 | Medline Convenience kits used for various procedures: 1) MINOR BASIN -SMH, M... | There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 3, 2025 | Medline Convenience kits used for various procedures: 1) DENTAL PACK-LF, Mod... | There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 3, 2025 | Medline Convenience kits used for various procedures: 1) STANDARD D&C, Model... | There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 3, 2025 | Medline Convenience kits used for various procedures: 1) LABOR AND DELIVERY ... | There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 3, 2025 | Medline Convenience kits used for various procedures: 1) DR. KHAN CABG ADDS ... | There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 3, 2025 | Medline Convenience kits used for various procedures: 1) PRECIP TRAY, Model ... | There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 3, 2025 | Medline Convenience kits used for various procedures: 1) INTUBATION TRAY, Mo... | There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 3, 2025 | Medline Convenience kits used for various procedures: 1) PAIN PACK, Model Nu... | There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 3, 2025 | Medline Convenience kits used for various procedures: 1) BASIC CATARACT, Mod... | There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 3, 2025 | Medline Convenience kits used for various procedures: 1) ANGIOGRAPHY DRAPE P... | There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 3, 2025 | Refer to RES | There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 3, 2025 | Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, M... | There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 3, 2025 | Medline Convenience kits used for various procedures: 1) UTHET TYLER OB PACK... | There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
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.