Browse Device Recalls
39,949 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,949 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 39,949 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 17, 2025 | Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. ... | Due to customer complaints, there is a potential for users to be unable to or find it difficult t... | Class I | C.R. Bard Inc |
| Apr 17, 2025 | Bard¿ Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110 | Due to customer complaints, there is a potential for users to be unable to or find it difficult t... | Class I | C.R. Bard Inc |
| Apr 17, 2025 | Tornado Embolization Microcoil, intended for embolization of selective vessel... | Cook Medical identified that devices from the affected device lots may contain the incorrectly si... | Class II | Cook Incorporated |
| Apr 17, 2025 | Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300 | Due to customer complaints, there is a potential for users to be unable to or find it difficult t... | Class I | C.R. Bard Inc |
| Apr 17, 2025 | Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-... | Cook Medical identified that devices from the affected device lots may contain the incorrectly si... | Class II | Cook Incorporated |
| Apr 17, 2025 | Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-... | Cook Medical identified that devices from the affected device lots may contain the incorrectly si... | Class II | Cook Incorporated |
| Apr 17, 2025 | Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740 | Due to customer complaints, there is a potential for users to be unable to or find it difficult t... | Class I | C.R. Bard Inc |
| Apr 16, 2025 | Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, wi... | software issue that causes an error screen on a portable vital signs monitor when attaching video... | Class II | Remote Diagnostic Technologies Ltd. |
| Apr 16, 2025 | VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-02... | It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negati... | Class II | Luminex Corporation |
| Apr 15, 2025 | ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376. | Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 15, 2025 | Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498 | Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 15, 2025 | Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00... | Patient Monitor software update to address issues:1)May freeze at startup with MPM Application er... | Class II | Remote Diagnostic Technologies Ltd. |
| Apr 14, 2025 | Plus Initial Drill, Article Number: 103.170; | The referred batch was produced without the laser engraving of 7 mm. | Class II | Straumann USA LLC |
| Apr 14, 2025 | Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of th... | The perc pin adaptor AMCH07200 tightening knob was found to be inconvenient to the user and the t... | Class II | Augmedics Ltd. |
| Apr 14, 2025 | VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, o... | Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and ca... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Apr 14, 2025 | Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI cod... | Due to packaging mix up. Package of finished devices were reported to have an incorrect finished... | Class II | Prismatik Dentalcraft, Inc. |
| Apr 13, 2025 | Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit R... | Due to non-sterile products being labeled as sterile | Class II | Microtek Medical, Inc. |
| Apr 11, 2025 | Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09. | During internal product testing, it was observed that some packages to have incomplete seals (ste... | Class II | LeMaitre Vascular, Inc. |
| Apr 11, 2025 | MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+10... | Potential for the presence of visible foreign matter. | Class I | Nipro Renal Soultions USA, Corporation |
| Apr 11, 2025 | TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651... | During internal product testing, it was observed that some packages to have incomplete seals (ste... | Class II | LeMaitre Vascular, Inc. |
| Apr 11, 2025 | Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-... | During internal product testing, it was observed that some packages to have incomplete seals (ste... | Class II | LeMaitre Vascular, Inc. |
| Apr 11, 2025 | CODMAN Disposable Perforator, 14mm. Cranial perforator. | Inadequate weld that can potentially cause the product to disassemble. | Class I | Integra LifeSciences Corp. (NeuroSciences) |
| Apr 11, 2025 | iGo¿2 DC Car Adapter to be used with iGo¿2 Portable Oxygen Concentrator Syste... | Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing. | Class I | Medical Depot Inc. |
| Apr 11, 2025 | CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14... | Inadequate weld that can potentially cause the product to disassemble. | Class I | Integra LifeSciences Corp. (NeuroSciences) |
| Apr 11, 2025 | Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to na... | Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may del... | Class I | Centerline Biomedical Inc |
| Apr 10, 2025 | Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/... | Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any d... | Class I | Vyaire Medical |
| Apr 10, 2025 | CMS8000 Patient Monitor | Patient monitor has nine identified cybersecurity vulnerabilities. | Class II | Contec Medical Systems Co., Ltd. |
| Apr 10, 2025 | Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical ... | A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previo... | Class II | Tornier S.A.S. |
| Apr 10, 2025 | Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/... | Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any d... | Class I | Vyaire Medical |
| Apr 10, 2025 | CADD Solis HSPCA Pump | Pumps may experience Wireless Connection Modules intermittent connection alarms, which will inter... | Class I | Smiths Medical ASD, Inc. |
| Apr 10, 2025 | CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, ... | There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps. | Class I | Smiths Medical ASD, Inc. |
| Apr 10, 2025 | CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VI... | There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps. | Class I | Smiths Medical ASD, Inc. |
| Apr 10, 2025 | CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 ... | Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions... | Class I | Smiths Medical ASD, Inc. |
| Apr 10, 2025 | 3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370 | Field action to clarify the flow rates and inlet fluid temperatures, along with location of the o... | Class I | 3M Company |
| Apr 10, 2025 | CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO... | Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions... | Class I | Smiths Medical ASD, Inc. |
| Apr 9, 2025 | Centurion Sterile Weitlaner Retractor, Reorder: 67315 | Three is the potential for the retractors to puncture through the sterile packaging. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 9, 2025 | PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acousti... | The high voltage capacitor may fail early in the product life cycle after delivery of surge volta... | Class II | Richard Wolf GmbH |
| Apr 9, 2025 | FoundationOne Companion Diagnostic (F1CDx) | Four (4) total reports were sent to customers with clinically relevant variants requiring amendme... | Class II | Foundation Medicine, Inc. |
| Apr 9, 2025 | Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395 | Three is the potential for the retractors to puncture through the sterile packaging. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2025 | REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487;... | Due to a software issue, the software may incorrectly process the date of birth (DoB) received fr... | Class II | Beckman Coulter Inc. |
| Apr 8, 2025 | Artix MT Thrombectomy Device, REF: 32-102 | Thrombectomy device specifies vessel range of 2.5-6 mm on the pouch, carton, and Instructions for... | Class II | Inari Medical - Oak Canyon |
| Apr 7, 2025 | Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2... | A cybersecurity vulnerability was discovered through internal testing. | Class I | Baxter Healthcare Corporation |
| Apr 7, 2025 | Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US | Incorrect labeling in which the front red pouch label did not match the actual size of the medica... | Class II | Ambu Inc. |
| Apr 7, 2025 | Molding Equipment. WCM series. Model WCM-330GL-i | Apic Yamada has recently discovered that certain products may be out of compliance with FDA elect... | Class II | Apic Yamada America |
| Apr 7, 2025 | Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-... | A cybersecurity vulnerability was discovered through internal testing. | Class I | Baxter Healthcare Corporation |
| Apr 7, 2025 | Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB ... | Vials of implant bone granules may contain less product then specified on labeling. | Class II | SCIENCE & BIO MATERIALS |
| Apr 7, 2025 | IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number... | An issue was identified with the software when using the Echo Module of ISCV, the issue may resul... | Class II | Philips Medical Systems Nederland B.V. |
| Apr 7, 2025 | Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt... | Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possi... | Class II | Philips North America Llc |
| Apr 4, 2025 | KliniTray. KlinioTray. Tissue resection margin examination board/small. Model... | Potential for microbial contamination. | Class II | Klinika Mdical Gmb |
| Apr 4, 2025 | Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: M... | Potential for internal fastening mechanism within generator of mobile x-Ray to fail. | Class II | Micro-X Ltd. |
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.