Browse Device Recalls
3,276 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,276 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 3,276 FDA device recalls in 2024.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 31, 2024 | Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Rec... | Due a potential software/configuration issue that may result is incorrect alignment during recons... | Class II | Hermes Medical Solutions AB |
| Oct 31, 2024 | BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475 | BD confirmed that product service credentials used by some BD technical support teams to access c... | Class II | Becton Dickinson & Co. |
| Oct 31, 2024 | BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: ... | BD confirmed that product service credentials used by some BD technical support teams to access c... | Class II | Becton Dickinson & Co. |
| Oct 31, 2024 | Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US... | Patients implanted with synthetic cartilage implant, may experience a higher-than expected occurr... | Class II | Cartiva, Inc |
| Oct 31, 2024 | BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Num... | BD confirmed that product service credentials used by some BD technical support teams to access c... | Class II | Becton Dickinson & Co. |
| Oct 31, 2024 | BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 4... | BD confirmed that product service credentials used by some BD technical support teams to access c... | Class II | Becton Dickinson & Co. |
| Oct 31, 2024 | BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444... | BD confirmed that product service credentials used by some BD technical support teams to access c... | Class II | Becton Dickinson & Co. |
| Oct 31, 2024 | BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990 | BD confirmed that product service credentials used by some BD technical support teams to access c... | Class II | Becton Dickinson & Co. |
| Oct 30, 2024 | Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to ... | Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld. | Class II | INCIPIO DEVICES |
| Oct 29, 2024 | Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small ... | Due to manufacturing defects observed on Locking Caps that affect the ability for components to m... | Class II | SEASPINE ORTHOPEDICS CORPORATION |
| Oct 29, 2024 | BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor. | Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the... | Class II | Smith & Nephew Inc. |
| Oct 29, 2024 | EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5... | Femoral implant porous size 5 right primary and femoral implant non-porous size 6 left primary ha... | Class II | MicroPort Orthopedics Inc. |
| Oct 29, 2024 | Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small... | Due to manufacturing defects observed on Locking Caps that affect the ability for components to m... | Class II | SEASPINE ORTHOPEDICS CORPORATION |
| Oct 28, 2024 | Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a de... | Due to incorrect labels applied to devices during servicing. Labels contain the incorrect produc... | Class III | Remote Diagnostic Technologies Ltd. |
| Oct 28, 2024 | Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnet... | Gradient coils for certain MR systems (see affected product list in this letter), under specific ... | Class II | GE Medical Systems, LLC |
| Oct 28, 2024 | SIGNA Architect, Nuclear Magnetic Resonance Imaging System | Gradient coils for certain MR systems (see affected product list in this letter), under specific ... | Class II | GE Medical Systems, LLC |
| Oct 28, 2024 | smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, R... | Smiths Medical has identified a potential for ingress of fluid into the device during reprocessin... | Class II | Smiths Medical ASD, Inc. |
| Oct 28, 2024 | Discovery MR750w 3.0T, whole body magnetic resonance scanner | Gradient coils for certain MR systems (see affected product list in this letter), under specific ... | Class II | GE Medical Systems, LLC |
| Oct 28, 2024 | smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76 | Smiths Medical has identified a potential for ingress of fluid into the device during reprocessin... | Class II | Smiths Medical ASD, Inc. |
| Oct 28, 2024 | SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System | Gradient coils for certain MR systems (see affected product list in this letter), under specific ... | Class II | GE Medical Systems, LLC |
| Oct 28, 2024 | Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of ... | Bronchoscopic visualization system power supplies have defective semiconductor components that ma... | Class II | Noah Medical |
| Oct 28, 2024 | smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-... | Smiths Medical has identified a potential for ingress of fluid into the device during reprocessin... | Class II | Smiths Medical ASD, Inc. |
| Oct 28, 2024 | AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O | Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UP... | Class II | Boston Scientific Corporation |
| Oct 28, 2024 | AMS Artificial Urinary Sphincter Control Pump | Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UP... | Class II | Boston Scientific Corporation |
| Oct 25, 2024 | ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Me... | Identified lots of Olympus product may be missing sterile and manufacturing lot numbers and expir... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 25, 2024 | Galaxy System (GAL-001) | Bronchoscopic system uninterruptable power may have defective component, may cause power supply s... | Class II | Noah Medical |
| Oct 25, 2024 | Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: ... | Not all biopsy tools meant to fit bronchoscope channel (2.1mm inner diameter/length greater or eq... | Class II | Noah Medical |
| Oct 24, 2024 | GE Proteus XR/A radiographic system | Steel cables in the Wall Stand for certain Proteus XR/a systems serviced by GE HealthCare have no... | Class II | GE Healthcare (China) Co., Ltd. |
| Oct 23, 2024 | URINALYSIS KIT 4, SKU DYLAB1021; Component No. 503581 | Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 23, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T... | There has been an increase in the number of complaints related to the separation of the female co... | Class II | Baxter Healthcare Corporation |
| Oct 23, 2024 | URINE KIT W/BD CUP, SKU DYLAB1001A; Component No. 503581 | Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 23, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R... | There has been an increase in the number of complaints related to the separation of the female co... | Class II | Baxter Healthcare Corporation |
| Oct 23, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R... | There has been an increase in the number of complaints related to the separation of the female co... | Class II | Baxter Healthcare Corporation |
| Oct 23, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R... | There has been an increase in the number of complaints related to the separation of the female co... | Class II | Baxter Healthcare Corporation |
| Oct 23, 2024 | URINE KIT, SKU DYKM1845; Component No. 503581 | Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 23, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5... | There has been an increase in the number of complaints related to the separation of the female co... | Class II | Baxter Healthcare Corporation |
| Oct 23, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R... | There has been an increase in the number of complaints related to the separation of the female co... | Class II | Baxter Healthcare Corporation |
| Oct 23, 2024 | Baxter MiniCap Extended Life PD Transfer Set (long) with Titanium Spike, Par... | There has been an increase in the number of complaints related to the separation of the female co... | Class II | Baxter Healthcare Corporation |
| Oct 23, 2024 | URINE COLLECTION KIT, SKU DYKM1848A DYKM2005 DYKM2151 DYLAB1004 DYLAB1004... | Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 23, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5... | There has been an increase in the number of complaints related to the separation of the female co... | Class II | Baxter Healthcare Corporation |
| Oct 23, 2024 | UA KIT, SKU DYKM1690A; Component No. 503581 | Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 23, 2024 | Baxter MiniCap Extended Life PD Transfer Set (short) with Titanium Spike, Pa... | There has been an increase in the number of complaints related to the separation of the female co... | Class II | Baxter Healthcare Corporation |
| Oct 23, 2024 | MICRO-X Rover Mobile X-ray System, # MXU-RV19 | During internal testing it was found that if the system is Ready to expose and the hand switch is... | Class II | Micro-X Ltd. |
| Oct 23, 2024 | Clean Catch Kit, SKU DYKM1833A; Component No. 503581 | Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 23, 2024 | URINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581 | Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 23, 2024 | Lab Kit, SKU DYLAB1018; Component No. 503581 | Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 23, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5... | There has been an increase in the number of complaints related to the separation of the female co... | Class II | Baxter Healthcare Corporation |
| Oct 23, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5... | There has been an increase in the number of complaints related to the separation of the female co... | Class II | Baxter Healthcare Corporation |
| Oct 22, 2024 | Allegedly counterfeit batteries manufactured by CSB batteries being used with... | ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infu... | Class I | ICU Medical, Inc. |
| Oct 22, 2024 | Ivalon Anatomical Nasal Packing with Airway Tube and String, 8.0 cm x 1.5cmx ... | Potential for package seal to be out of specification and the sterile barrier cannot be guarantee... | Class II | Carwild 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.