Browse Device Recalls
394 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 394 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 394 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 7, 2022 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482 | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... | Class II | Baxter Healthcare Corporation |
| Jan 7, 2022 | Baxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short, REF R... | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... | Class II | Baxter Healthcare Corporation |
| Jan 7, 2022 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482EJ | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... | Class II | Baxter Healthcare Corporation |
| Jan 7, 2022 | Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (24cm)), Code N... | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... | Class II | Baxter Healthcare Corporation |
| Jan 7, 2022 | Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (34cm)), Code N... | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... | Class II | Baxter Healthcare Corporation |
| Jan 7, 2022 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Long, R... | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... | Class II | Baxter Healthcare Corporation |
| Jan 7, 2022 | Baxter Equipo de transferencia para DP MiniCap de vida util prolongada con pi... | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... | Class II | Baxter Healthcare Corporation |
| Jan 7, 2022 | Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449 | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... | Class II | Baxter Healthcare Corporation |
| Jan 7, 2022 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short, ... | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... | Class II | Baxter Healthcare Corporation |
| Jan 7, 2022 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482E | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... | Class II | Baxter Healthcare Corporation |
| Dec 29, 2021 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Pro... | There is the potential for reduced or non-delivery of medication, in some cases without alerting ... | Class I | Baxter Healthcare Corporation |
| Dec 29, 2021 | Baxter Spectrum IQ Infusion Pumps, Product code 3570009. | There is the potential for reduced or non-delivery of medication, in some cases without alerting ... | Class I | Baxter Healthcare Corporation |
| Sep 29, 2021 | Hemodialysis Delivery System, Software Version 2.x. | If the operator initiates therapy with a saved prescription profile and makes a change to the pr... | Class II | Baxter Healthcare Corporation |
| Jul 22, 2021 | Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET... | Products labeled as sterile were distributed, but may not have been sterilized. " Baxter confirm... | Class II | Baxter Healthcare Corporation |
| Jul 22, 2021 | Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex... | Products labeled as sterile were distributed, but may not have been sterilized. Baxter confirmed... | Class II | Baxter Healthcare Corporation |
| Jul 7, 2021 | Dose IQ Safety Software used with Spectrum IQ Infusion Pump | Software issue: The defect creates a mismatch between linked drug identifiers (IDs) in the Dose ... | Class I | Baxter Healthcare Corporation |
| Jun 30, 2021 | Kaguya Automated Peritoneal Dialysis System | Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used wi... | Class II | BAXTER HEALTHCARE CORPORATION |
| Jun 30, 2021 | Sharesource Connectivity Platform for Use with the Amia Automated PD System | Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used wi... | Class II | BAXTER HEALTHCARE CORPORATION |
| Jun 15, 2021 | EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites throu... | There is a discrepancy in the expiry date encoded into the 2D barcode. The correct expiration dat... | Class II | Baxter Healthcare Corporation |
| Jun 4, 2021 | Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 357000... | System errors were noted following changes the customers implemented to the configuration of thei... | Class I | Baxter Healthcare Corporation |
| Apr 14, 2021 | Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for... | There is a potential leak between the venous patient connector and patient's hemodialysis access. | Class II | Baxter Healthcare Corporation |
| Mar 19, 2021 | Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the cont... | Potentially defective component in the AC power adapter which may fail over time. | Class II | Baxter Healthcare Corporation |
| Jan 28, 2021 | Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replaceme... | Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repos... | Class II | Baxter Healthcare Corporation |
| Jan 28, 2021 | Preventative Maintenance Kits G5010007) and spare part kits (G5064801 and G50... | Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repos... | Class II | Baxter Healthcare Corporation |
| Jan 28, 2021 | Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacemen... | Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repos... | Class II | Baxter Healthcare Corporation |
| Jan 28, 2021 | Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacemen... | Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repos... | Class II | Baxter Healthcare Corporation |
| Jan 7, 2021 | The PrisMax System Version II Hemodialysis Delivery System: Automatic Reposit... | Variability in the performance of the tubing in the ARPS (Automatic Repositioning System) Pump As... | Class II | Baxter Healthcare Corporation |
| Jan 6, 2021 | Infusion Pump | Battery performance issues related to prolonged storage. | Class II | Baxter Healthcare Corporation |
| Dec 30, 2020 | Gambro Cartridge Single Needle Conversion Kit, product code 101290 - Product ... | complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis... | Class II | Baxter Healthcare Corporation |
| Dec 30, 2020 | Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysi... | complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis... | Class II | Baxter Healthcare Corporation |
| Dec 30, 2020 | Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set... | complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis... | Class II | Baxter Healthcare Corporation |
| Dec 30, 2020 | Gambro Cartridge Blood Set Prime Line, product code 101025 - Product Usage: i... | complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis... | Class II | Baxter Healthcare Corporation |
| Dec 30, 2020 | Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product c... | complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis... | Class II | Baxter Healthcare Corporation |
| Dec 30, 2020 | Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product c... | complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis... | Class II | Baxter Healthcare Corporation |
| Dec 28, 2020 | FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 m... | Potential for the battery to lose its ability to be recharged. | Class II | Baxter Healthcare Corporation |
| Dec 21, 2020 | Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Need... | There were customer reports of separation between the tubing and Male Luer Lock Adaptor. | Class II | Baxter Healthcare Corporation |
| Dec 11, 2020 | VERITAS Collagen Matrix - Product Usage: intended for use in reconstruction o... | VERITAS Collagen Matrix 12x25 cm Patches may have undersized width dimensions. | Class II | Baxter Healthcare Corporation |
| Nov 23, 2020 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Pr... | There is a potential software error during programming. | Class II | Baxter Healthcare Corporation |
| Nov 23, 2020 | Baxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usa... | There is a potential software error during programming. | Class II | Baxter Healthcare Corporation |
| Nov 23, 2020 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Pr... | There is a potential software error during programming. | Class II | Baxter Healthcare Corporation |
| Nov 23, 2020 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Pr... | There is a potential software error during programming. | Class II | Baxter Healthcare Corporation |
| Nov 10, 2020 | MiniCap Extended Life PD Transfer Set | Potential for no-flow and leaks under the twist clamp. | Class II | Baxter Healthcare Corporation |
| Jun 30, 2020 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) | Baxter is updating the device IFU for safety communication regarding cleaning practices. | Class I | Baxter Healthcare Corporation |
| Jun 30, 2020 | Spectrum IQ Infusion System with Dose IQ Safety Software | Baxter is updating the device IFU for safety communication regarding cleaning practices. | Class I | Baxter Healthcare Corporation |
| Jun 30, 2020 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) | Baxter is updating the device IFU for safety communication regarding cleaning practices. | Class I | Baxter Healthcare Corporation |
| Jun 30, 2020 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) | Baxter is updating the device IFU for safety communication regarding cleaning practices. | Class I | Baxter Healthcare Corporation |
| Jun 2, 2020 | Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only | A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a... | Class II | Baxter Healthcare Corporation |
| Apr 17, 2020 | Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set... | Potential disconnection of tubing set. | Class II | Baxter Healthcare Corporation |
| Apr 17, 2020 | Gambro Cartridge Blood Transport System for Hemodialysis Blood Set - Product ... | Potential disconnection of tubing set. | Class II | Baxter Healthcare Corporation |
| Apr 17, 2020 | Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single... | Potential disconnection of tubing set. | 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.