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 31, 2025 | Straight Inflow/Outflow Patient Line Kit. Model Number: 902-00037. Steri... | Potential crack in the female connector located on the Heat Exchanger in the set, which will lead... | Class II | Belmont Instrument LLC |
| Mar 31, 2025 | Halyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit. | An issue with a raw material used to coat some surgical needles that may result in diminished per... | Class II | AVID Medical, Inc. |
| Mar 31, 2025 | Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparin... | Siemens Healthcare Diagnostics Inc., is recalling their Stratus CS Acute Care cTNI TestPak, an IV... | Class II | Siemens Healthcare Diagnostics Inc |
| Mar 28, 2025 | Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S; | The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the ... | Class II | Stryker GmbH |
| Mar 28, 2025 | Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S; | The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the ... | Class II | Stryker GmbH |
| Mar 28, 2025 | Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: M... | Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load... | Class II | Micro-X Ltd. |
| Mar 28, 2025 | Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: M... | Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load... | Class II | Micro-X Ltd. |
| Mar 27, 2025 | Beckman Coulter DxI 9000 Access Immunoassay Analyzer | When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information s... | Class II | Beckman Coulter, Inc. |
| Mar 27, 2025 | GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intende... | Due to a potential open seal in the sterile barrier packaging . | Class II | Galt Medical Corporation |
| Mar 27, 2025 | Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34... | Due to a potential open seal in the sterile barrier packaging. | Class II | Galt Medical Corporation |
| Mar 27, 2025 | Introducer Needle REF NDL-107-04 These needles are used for the percutane... | Due to a potential open seal in the sterile barrier packaging. | Class II | Galt Medical Corporation |
| Mar 27, 2025 | Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101... | Due to a potential open seal in the sterile barrier packaging. | Class II | Galt Medical Corporation |
| Mar 27, 2025 | B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-0... | Due to a potential open seal in the sterile barrier packaging . | Class II | Galt Medical Corporation |
| Mar 27, 2025 | Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount | The mounting hardware that is supplied with the 4FXS-60 monitor bracket does not provide adequate... | Class II | IHB OPERATIONS B.V. |
| Mar 27, 2025 | GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutan... | Due to a potential open seal in the sterile barrier packaging. | Class II | Galt Medical Corporation |
| Mar 27, 2025 | B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 61280... | Due to a potential open seal in the sterile barrier packaging . | Class II | Galt Medical Corporation |
| Mar 26, 2025 | The Trimble RTS873 robotic total station is a solution designed for construct... | An issue has been identified in the production of the RTS873 robotic total stations that may resu... | Class II | Trimble Ab |
| Mar 25, 2025 | restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: H... | The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 178... | Class II | Conformis Inc. |
| Mar 24, 2025 | Intera 0.5T Standard, Model Number: 781101; | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 24, 2025 | Intera 1.5T Omni/Stellar, Model Number: 781104; | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 24, 2025 | Enterprise 1.5T, Model Number: 781145; | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 24, 2025 | Intera 3.0T Quasar Dual, Model Number: 781150; | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 24, 2025 | Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Num... | The associated product labeling does not adequately provide compatibility information for use of ... | Class II | Zimmer, Inc. |
| Mar 24, 2025 | IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The nee... | Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and Fe... | Class II | Boston Scientific Corporation |
| Mar 24, 2025 | Intera 1.5T Power/Pulsar, Model Number: 781105; | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 24, 2025 | IceSeed 1.5 CX NEEDLE US, Cryoablation Needle, REF H7493967433170. The needl... | Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and Fe... | Class II | Boston Scientific Corporation |
| Mar 24, 2025 | Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, -3 Neck, Model Number 8... | The associated product labeling does not adequately provide compatibility information for use of ... | Class II | Zimmer, Inc. |
| Mar 24, 2025 | Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 8... | The associated product labeling does not adequately provide compatibility information for use of ... | Class II | Zimmer, Inc. |
| Mar 24, 2025 | Intera CV, Model Number: 781107; | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 24, 2025 | Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetell... | It was determined that there could be a false positive rate of up to 16.7% for the affected lots ... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Mar 24, 2025 | Intera 1.0T Power/Pulsar, Model Number: 781103; | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 24, 2025 | Intera 1.5T, Model Numbers: 781195 and 781295; | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 24, 2025 | Welch Allyn CP150 Electrocardiograph: | There were customer reports of devices which experienced battery-related fires. The investigation... | Class II | Baxter Healthcare Corporation |
| Mar 24, 2025 | Intera 1.5T R11, Model Number: 781170; | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 24, 2025 | Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Num... | The associated product labeling does not adequately provide compatibility information for use of ... | Class II | Zimmer, Inc. |
| Mar 24, 2025 | Intera 1.5T Master/Nova, Model Number: 781106; | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 24, 2025 | Welch Allyn CONNEX Accessory Power Management Stand: | There were customer reports of devices which experienced battery-related fires. The investigation... | Class II | Baxter Healthcare Corporation |
| Mar 24, 2025 | IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The ne... | Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and Fe... | Class II | Boston Scientific Corporation |
| Mar 24, 2025 | Intera 1.5T Explorer/Nova Dual, Model Number: 781108; | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 24, 2025 | SmartPath to dStream for 3.0T, Model Number: 782145; | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 24, 2025 | Welch Allyn Connex Vital Signs Monitor (CVSM): | There were customer reports of devices which experienced battery-related fires. The investigation... | Class II | Baxter Healthcare Corporation |
| Mar 24, 2025 | Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 7... | A single lot of the ImmunoCard STAT! Crypto/Giardia Test Kit was inadvertently stored in Medline ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 24, 2025 | IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The need... | Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and Fe... | Class II | Boston Scientific Corporation |
| Mar 24, 2025 | Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 8... | The associated product labeling does not adequately provide compatibility information for use of ... | Class II | Zimmer, Inc. |
| Mar 24, 2025 | SmartPath to dStream for 1.5T, Model Number: 782146; | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 24, 2025 | Intera 1.0T Omni/Stellar, Model Number: 781102; | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 21, 2025 | Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH... | Undeclared natural rubber band within the packaging of certain configurations of reusable blood p... | Class II | Baxter Healthcare Corporation |
| Mar 21, 2025 | Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44... | Undeclared natural rubber band within the packaging of certain configurations of reusable blood p... | Class II | Baxter Healthcare Corporation |
| Mar 21, 2025 | OEC 3D | OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field. | Class II | GE Medical Systems, LLC |
| Mar 21, 2025 | Welch Allyn Connex Integrated Wall System, Product Code/Part Numbers: 1) 8... | Undeclared natural rubber band within the packaging of certain configurations of reusable blood p... | Class II | Baxter Healthcare Corporation |
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.