Browse Device Recalls
35,653 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,653 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 35,653 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 21, 2025 | BIB Balloon in Balloon Dilatation Catheter. Model Number: 420 | Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub... | Class II | Numed Inc |
| Apr 21, 2025 | BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: ... | Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in bloo... | Class II | Becton Dickinson Infusion Therapy Systems, Inc. |
| Apr 21, 2025 | LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KN... | Test results for cast padding component included in procedure trays shows Ethylene Oxide/Ethylene... | Class II | American Contract Systems, Inc. |
| Apr 21, 2025 | Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon... | Sampling set nasal cannula used with End-Tidal Carbon Monoxide (ETCO) monitor may have residual c... | Class II | Capnia Inc |
| Apr 17, 2025 | WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments. | Incorrect blister labelling. | Class II | Straumann USA LLC |
| 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 | 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 | 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 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 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 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 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 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 | 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 | 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 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 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 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 | 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 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 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 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 | 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 | 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 | 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 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 | 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 | 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 | 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 4, 2025 | Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro Supe... | Preset treatment parameters are not consistently being used in accordance with the IFU. | Class II | Olympus Corporation of the Americas |
| Apr 4, 2025 | KliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examinat... | Potential for microbial contamination. | Class II | Klinika Mdical Gmb |
| Apr 4, 2025 | INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation cath... | Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Apr 4, 2025 | Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MX... | Potential for internal fastening mechanism within generator of mobile x-Ray to fail. | Class II | Micro-X Ltd. |
| 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. |
| Apr 4, 2025 | KliniTray. KlinioTray. Tissue resection margin examination board/small. Model... | Potential for microbial contamination. | Class II | Klinika Mdical Gmb |
| Apr 3, 2025 | MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S; | Devices for the affected lot were not assembled according to product specifications. The distrac... | Class II | Globus Medical, Inc. |
| Apr 3, 2025 | L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm),... | The device was delivered with a preassembled Femoral Augment screw that was missing its thread. | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Apr 3, 2025 | Enhanced Verify Evaluation Handset (CFN HH90130FA) | Evaluation handsets may not be able to communicate with the neurostimulator due to handsets havin... | Class II | Medtronic Neuromodulation |
| Apr 3, 2025 | Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm)... | The device was delivered with a preassembled Femoral Augment screw that was missing its thread. | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Apr 3, 2025 | Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulato... | Potential for exoskeleton to lose lateral balance and cause patient to fall. | Class II | WANDERCRAFT SAS |
| Apr 3, 2025 | Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 8... | The device was delivered with a preassembled Femoral Augment screw that was missing its thread. | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Apr 3, 2025 | Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (... | The device was delivered with a preassembled Femoral Augment screw that was missing its thread. | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Apr 2, 2025 | Washer Disinfector Aquadis 56; Model Number: 56A | The frequency inverter is not programmed by supplier according to specification which causes the ... | Class II | Getinge Disinfection Ab |
| Apr 2, 2025 | Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat... | Due to manufacturing issues, abutment products were manufactured with screw seat located too high... | Class II | Preat Corp |
| Apr 2, 2025 | Washer Disinfector Aquadis 56; Model Number: 56M | The frequency inverter is not programmed by supplier according to specification which causes the ... | Class II | Getinge Disinfection Ab |
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.