Browse Device Recalls
460 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 460 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 460 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 11, 2024 | Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If th... | Class II | Baxter Healthcare Corporation |
| Oct 11, 2024 | Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If th... | Class II | Baxter Healthcare Corporation |
| Oct 2, 2024 | Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code... | The door on the Spectrum IQ Infusion pump may not be able to fully close. | Class II | Baxter Healthcare Corporation |
| Sep 19, 2024 | Baxter Operating Table TruSystem 7000 U14 (MBW) V, Product code REF 2065386 | The firm received customer reports stating that the batteries and their connectors experienced el... | Class II | Baxter Healthcare Corporation |
| Sep 19, 2024 | Baxter Operating Table TruSystem 7000 (MBW), Product code REF 1841048 | The firm received customer reports stating that the batteries and their connectors experienced el... | Class II | Baxter Healthcare Corporation |
| Sep 19, 2024 | Baxter Operating table TruSystem 7000 U (MB), Product codes: a) REF 160478... | The firm received customer reports stating that the batteries and their connectors experienced el... | Class II | Baxter Healthcare Corporation |
| Sep 19, 2024 | Baxter Operating Table TruSystem 7000 (dV), Product code REF 1841049 | The firm received customer reports stating that the batteries and their connectors experienced el... | Class II | Baxter Healthcare Corporation |
| Sep 19, 2024 | Baxter Operating Table TruSystem 7000, Product code REF 1841046 | The firm received customer reports stating that the batteries and their connectors experienced el... | Class II | Baxter Healthcare Corporation |
| Sep 19, 2024 | Baxter Operating Table TruSystem 7000 V, Product code REF 1841050 | The firm received customer reports stating that the batteries and their connectors experienced el... | Class II | Baxter Healthcare Corporation |
| Sep 19, 2024 | Baxter Operating Table TruSystem 7000 (MBW) V, Product code REF 1841082 | The firm received customer reports stating that the batteries and their connectors experienced el... | Class II | Baxter Healthcare Corporation |
| Sep 19, 2024 | Baxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385 | The firm received customer reports stating that the batteries and their connectors experienced el... | Class II | Baxter Healthcare Corporation |
| Sep 19, 2024 | Baxter Operating Table TruSystem 7000 (dV) V, Product code REF 1841083 | The firm received customer reports stating that the batteries and their connectors experienced el... | Class II | Baxter Healthcare Corporation |
| Sep 18, 2024 | a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P... | The beds have a potential for an interface issue with the Rauland Responder 5 Nurse Call System w... | Class II | Baxter Healthcare Corporation |
| Sep 12, 2024 | Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior cart... | The Life2000 ventilator may fail to initiate the Low Gas Pressure alarm if the pressure gas sourc... | Class I | Baxter Healthcare Corporation |
| Aug 20, 2024 | Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use i... | Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... | Class I | Baxter Healthcare Corporation |
| Aug 20, 2024 | Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a... | Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... | Class I | Baxter Healthcare Corporation |
| Aug 20, 2024 | Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a ... | Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... | Class I | Baxter Healthcare Corporation |
| Aug 20, 2024 | Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a phar... | Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... | Class I | Baxter Healthcare Corporation |
| Jul 17, 2024 | Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used wi... | The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Ele... | Class II | Baxter Healthcare Corporation |
| Jul 17, 2024 | Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with eith... | The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Ele... | Class II | Baxter Healthcare Corporation |
| Jun 28, 2024 | Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300 | Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the PST 500 U Pr... | Class II | Baxter Healthcare Corporation |
| Jun 14, 2024 | Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2 | Improperly performed testing prior to release | Class II | Baxter Healthcare Corporation |
| Jun 13, 2024 | Braun Thermoscan¿ PRO 6000 Ear Thermometer | The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) con... | Class II | Baxter Healthcare Corporation |
| Jun 4, 2024 | VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 40... | Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer repo... | Class II | Baxter Healthcare Corporation |
| Jun 4, 2024 | iLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical... | Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer repo... | Class II | Baxter Healthcare Corporation |
| Jun 4, 2024 | Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical... | Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer repo... | Class II | Baxter Healthcare Corporation |
| Jun 3, 2024 | Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP... | During manufacturing, the step to install an Electromagnetic Interference (EMI) Absorber was omit... | Class II | Baxter Healthcare Corporation |
| May 30, 2024 | Volara System. Blue Ventilator Adapter Module. Intermittent positive pressur... | Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapte... | Class I | Baxter Healthcare Corporation |
| May 30, 2024 | Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Pa... | Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapte... | Class I | Baxter Healthcare Corporation |
| May 29, 2024 | Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life... | Potential for certain Life2000 ventilator systems to either fail to charge or have intermittent c... | Class I | Baxter Healthcare Corporation |
| May 8, 2024 | Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare en... | There is a potential for the top cover of the hospital bed mattress to delaminate as a result of ... | Class II | Baxter Healthcare Corporation |
| Apr 9, 2024 | Spectrum IQ Infusion pump, Product Code 357009 | There is a potential for cracks on the mount of the front panel of the device. | Class II | Baxter Healthcare Corporation |
| Mar 26, 2024 | Hillrom Welch Allyn Spot Vision Screener VS100, marketed under the following ... | Baxter received reports of an issue related to the construction of the power cord not meeting the... | Class II | Baxter Healthcare Corporation |
| Mar 26, 2024 | Power Cords, marketed under the following models: a) CORD,METAL EARTH PIN,... | Baxter received reports of an issue related to the construction of the power cord not meeting the... | Class II | Baxter Healthcare Corporation |
| Mar 26, 2024 | Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed... | Baxter received reports of an issue related to the construction of the power cord not meeting the... | Class II | Baxter Healthcare Corporation |
| Mar 20, 2024 | Baxter Spectrum IQ Infusion Pump, Product Code 3570009 | One device was improperly performed testing prior to release from a Service Center. | Class II | Baxter Healthcare Corporation |
| Mar 15, 2024 | Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in ... | Product was distributed in the United States without proper regulatory approval. | Class II | Baxter Healthcare Corporation |
| Mar 11, 2024 | HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to positi... | Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Hip Distraction ... | Class II | Baxter Healthcare Corporation |
| Mar 5, 2024 | Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended fo... | Inconsistencies were identified with service records associated with corrections performed for a ... | Class II | Baxter Healthcare Corporation |
| Feb 28, 2024 | Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b... | A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not... | Class II | Baxter Healthcare Corporation |
| Feb 28, 2024 | Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b)... | A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not... | Class II | Baxter Healthcare Corporation |
| Feb 28, 2024 | Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608... | A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not... | Class II | Baxter Healthcare Corporation |
| Feb 28, 2024 | Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNB... | A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not... | Class II | Baxter Healthcare Corporation |
| Feb 22, 2024 | Surgical Tools and Cardiovascular Specialty marketing brochures, Reference nu... | The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Di... | Class II | Baxter Healthcare Corporation |
| Feb 22, 2024 | Surgical Tools and Cardiovascular Specialty marketing brochures, Reference nu... | The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Di... | Class II | Baxter Healthcare Corporation |
| Feb 22, 2024 | Surgical Tools and Cardiovascular Specialty marketing brochures, Reference nu... | The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Di... | Class II | Baxter Healthcare Corporation |
| Feb 14, 2024 | STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192 | Three lots of the Boot Assembly, Traction Device are being recalled due to due to a customer repo... | Class II | Baxter Healthcare Corporation |
| Feb 8, 2024 | CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401 | Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Clearlink Non-DE... | Class II | Baxter Healthcare Corporation |
| Dec 22, 2023 | Baxter Exactamix Pro 2400, REF EXM24DY | An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" ... | Class I | Baxter Healthcare Corporation |
| Dec 22, 2023 | Baxter Exactamix Pro 1200, REF EXM12DY | An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" ... | Class I | 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.