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 |
|---|---|---|---|---|
| Feb 25, 2025 | Baxter Floor mounting column TruSystem 7500, Product Code 1717021 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Baxter TruSystem 7500 Hybrid Plus (SC), Product Code 1854088 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Baxter TruSystem 7500 Hybrid (FC), Product Code 1854085 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or ... | The air bladders inside the mattress may move out of position when the head of the bed is elevate... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Baxter Operating table column TS7500 MOBIUS, Product Code 1704695 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Baxter Stationary column TruSystem 7500 U, Product Code 1730731 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Baxter Stationary column TruSystem 7500, Product Code 1717020 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Baxter TruSystem 7500, Product Code 4091000 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Baxter Mobile column TruSystem 7500 U, Product Code 1730720 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 5, 2025 | Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code... | There is the potential for missing motor mounting screws, which may have occurred during the serv... | Class I | Baxter Healthcare Corporation |
| Feb 5, 2025 | Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX | There is the potential for missing motor mounting screws, which may have occurred during the serv... | Class I | Baxter Healthcare Corporation |
| Dec 20, 2024 | Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A | There is an issue with the ventilator battery charger that could lead to an audible and visual al... | Class I | Baxter Healthcare Corporation |
| Dec 20, 2024 | Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP | There is an issue with the ventilator battery charger that could lead to an audible and visual al... | Class I | Baxter Healthcare Corporation |
| Dec 20, 2024 | Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538 | Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps ca... | Class II | Baxter Healthcare Corporation |
| Dec 20, 2024 | Baxter Solution Set with Duo-Vent Spike, REF 2R8404 | Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps ca... | Class II | Baxter Healthcare Corporation |
| Dec 20, 2024 | Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP | There is an issue with the ventilator battery charger that could lead to an audible and visual al... | Class I | Baxter Healthcare Corporation |
| Dec 20, 2024 | Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519 | Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps ca... | Class II | Baxter Healthcare Corporation |
| Dec 20, 2024 | Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002 | There is an issue with the ventilator battery charger that could lead to an audible and visual al... | Class I | Baxter Healthcare Corporation |
| Nov 19, 2024 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Pro... | Devices were identified as released after repair without full testing being performed, which incl... | Class II | Baxter Healthcare Corporation |
| Nov 19, 2024 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Pr... | Devices were identified as released after repair without full testing being performed, which incl... | Class II | Baxter Healthcare Corporation |
| 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 | 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 | 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 | 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 (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 | 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 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp EX Short, Part... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 16, 2024 | Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607 | Baxter is aware of several recalls by other manufacturers related to the potential risk of expos... | Class I | Baxter Healthcare Corporation |
| Oct 11, 2024 | Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagn... | 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 HScribe Holter System; ambulatory monitoring | 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 RScribe 12-Lead Electrocardiograph System; Electrocardiog... | 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 Diagnostic Cardiology Suite (formerly Connex Cardio); Dia... | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If th... | 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.