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 |
|---|---|---|---|---|
| Jan 8, 2024 | BD BBL Sensi Disc Clarithromycin- 15 ug, used for semi-quantitative in vitro ... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Piperacillin/Tazobactam- 100/10 ug, used for semi-quantita... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Azithromycin -15 ¿g, Catalog Number 231682¿used for semi-qu... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro suscept... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Cefpodoxime - 10 ug, used for semi-quantitative in vitro su... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | Sensi Disc Amoxicillin with Clavulanic Acid 20/10 ¿g, Catalog No. 231628 an... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 8, 2024 | BD BBL Sensi Disc Minocycline - 30 ug, used for semi-quantitative in vitro s... | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... | Class II | Becton Dickinson & Co. |
| Jan 5, 2024 | OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Min... | OPTIMIZER devices may cease to deliver CCM therapy if the device incorrectly detects a charging e... | Class II | IMPULSE DYNAMICS (USA) INC |
| Jan 5, 2024 | Hemostasis Probe, Model: CD-B622LA | The BICOAG Hemostasis Probe with a coaxial plug was mispackaged into the package and labeled as a... | Class II | Olympus Corporation of the Americas |
| Jan 4, 2024 | Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe | Packaging material was updated for the Bulb Irrigation Syringe (DYND20125), and additional testin... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jan 3, 2024 | Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DW... | The incorrect device is contained in the labeled package. | Class II | Tornier, Inc |
| Jan 3, 2024 | Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application a... | The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the ma... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jan 3, 2024 | Intera 1.5T Achieva Nova. Model (REF) Numbers 781172. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a... | One lot of the Sofia 2 Flu + SARS Antigen FIA (Lot 709083) was labelled with incorrect expiration... | Class II | Quidel Corporation |
| Jan 3, 2024 | SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782... | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Achieva 3.0T. Model. (REF) Numbers 781277, 781177, 781278, 781344, 781345. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Ingenia 1.5T CX. Model (REF) Numbers 781262, 781261. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Intera Achieva 1.5T Pulsar. Model (REF) Number 781171. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the follow... | Their is a potential that the implant curved stem may be oriented incorrectly. | Class II | United Orthopedic Corporation |
| Jan 3, 2024 | Achieva 1.5T Conversion. Model (REF) Numbers 781346, 781283. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Intera 1.5T Achieva Nova-Dual. Model (REF) Number 781173. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Neurovascular embolization device. The Optima Coil System is a series special... | Discoloration was identified along the delivery pusher which was attributed to corrosion of the h... | Class II | BALT USA, LLC |
| Jan 3, 2024 | The Prestige Coil System is a product family of embolic coils with associated... | Discoloration was identified along the delivery pusher which was attributed to corrosion of the h... | Class II | BALT USA, LLC |
| Jan 3, 2024 | USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following ... | Their is a potential that the implant curved stem may be oriented incorrectly. | Class II | United Orthopedic Corporation |
| Jan 3, 2024 | SmartPath to dStream for 1.5T. Model (REF) Numbers 781260, 782112. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Achieva XR. Model (REF) Numbers 781153, 781253. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; ... | A software error caused an increase in tray gripper motion errors that causes intermittent hard s... | Class II | Beckman Coulter, Inc. |
| Jan 3, 2024 | Synapse CV 6. with AR. A web-based application as the primary user interfa... | The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the ma... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jan 3, 2024 | Achieva 1.5T Initial system. Model (REF) Numbers 781178. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference N... | Their is a potential that the implant curved stem may be oriented incorrectly. | Class II | United Orthopedic Corporation |
| Jan 2, 2024 | Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically t... | Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 2, 2024 | 3:1 Dermacarrier, Model Number 00219501300, skin graft carrier | Due to manufacturing issue, the product is labeled as 3:1 ratio, but the ridge pattern is a 1.5:1... | Class II | Zimmer Surgical Inc |
| Jan 2, 2024 | Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the D... | Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 2, 2024 | Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically t... | Dual In-Line Memory Modules (DIMMs) may not perform as intended. System may stop functioning and ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 2, 2024 | Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the D... | Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 2, 2024 | Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically t... | Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 29, 2023 | MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm)... | Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed a... | Class II | Aesculap Inc |
| Dec 29, 2023 | MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC M... | Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed a... | Class II | Aesculap Inc |
| Dec 28, 2023 | Bubble Sensor (REF: 70105.5720) | The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system inclu... | Class II | Maquet Medical Systems USA |
| Dec 28, 2023 | Samsung Digital Diagnostic Mobile X-ray System, Model GM85. | Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm d... | Class II | NeuroLogica Corporation |
| Dec 28, 2023 | AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL,... | The saline flush syringes may fail to meet USP criteria for stated sodium chloride content after ... | Class II | MRP, LLC dba Aquabiliti |
| Dec 27, 2023 | Impella catheters - Intravascular micro axial blood pumps that support a pati... | New warnings are being added to the Instructions for Use for all affected products to reduce the ... | Class II | Abiomed, Inc. |
| Dec 27, 2023 | Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible... | Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately | Class II | TruAbutment Inc. |
| Dec 26, 2023 | Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002 | Knee batteries may need replacement with conforming batteries to ensure there isn't a failure to ... | Class II | Ossur H / F |
| Dec 26, 2023 | Senographe Pristina | X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermit... | Class II | GE Medical Systems, SCS |
| Dec 22, 2023 | GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ul... | GE HealthCare has become aware of an issue with certain IC9-RS ultrasound probes (see Affected Pr... | Class II | GE HEALTHCARE AUSTRIA GMBH & CO |
| Dec 22, 2023 | AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (... | Filling process qualification did not demonstrate adequate process capability. Possible consequen... | Class II | Musculoskeletal Transplant Foundation, Inc. |
| Dec 22, 2023 | ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03... | Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that ... | Class II | Onkos Surgical, 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.