Browse Device Recalls
3,664 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,664 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 3,664 FDA device recalls, Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 11, 2025 | BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309U | Laryngoscope handles may not illuminate as intended. | Class I | Flexicare Medical (Dongguan) Ltd. |
| Jul 11, 2025 | BritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac 1... | Laryngoscope handles may not illuminate as intended. | Class I | Flexicare Medical (Dongguan) Ltd. |
| Jul 11, 2025 | Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0... | Laryngoscope handles may not illuminate as intended. | Class I | Flexicare Medical (Dongguan) Ltd. |
| Jul 11, 2025 | BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and ... | Laryngoscope handles may not illuminate as intended. | Class I | Flexicare Medical (Dongguan) Ltd. |
| Jul 11, 2025 | BritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415U | Laryngoscope handles may not illuminate as intended. | Class I | Flexicare Medical (Dongguan) Ltd. |
| Jul 11, 2025 | BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-011... | Laryngoscope handles may not illuminate as intended. | Class I | Flexicare Medical (Dongguan) Ltd. |
| Jul 11, 2025 | Plum Duo Infusion System, List Number: 400020401 | ICU Medical identified two sequences of programming events and alarm interactions that may cause ... | Class I | ICU Medical, Inc. |
| Jul 10, 2025 | IDM-MICRO-R. Electrical wheelchair component. | Devices with firmware versions 2.3 and lower may experience timing variations between software ta... | Class I | mo-Vis BVBA |
| Jul 10, 2025 | Multi Joystick R-net. Electrical wheelchair component. | Devices with firmware versions 2.3 and lower may experience timing variations between software ta... | Class I | mo-Vis BVBA |
| Jul 10, 2025 | IDM-MULTI-R. Electrical wheelchair component. | Devices with firmware versions 2.3 and lower may experience timing variations between software ta... | Class I | mo-Vis BVBA |
| Jul 10, 2025 | All-round Joystick R-net Light. Electrical wheelchair component. | Devices with firmware versions 2.3 and lower may experience timing variations between software ta... | Class I | mo-Vis BVBA |
| Jul 10, 2025 | IDM-ARLITE-R. Electrical wheelchair component. | Devices with firmware versions 2.3 and lower may experience timing variations between software ta... | Class I | mo-Vis BVBA |
| Jul 10, 2025 | Micro Joystick R-net. Electrical wheelchair component. | Devices with firmware versions 2.3 and lower may experience timing variations between software ta... | Class I | mo-Vis BVBA |
| Jul 9, 2025 | Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for us... | Label is incorrect. The product label indicates that the device contains an air eliminating filte... | Class I | B BRAUN MEDICAL INC |
| Jul 9, 2025 | Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, C... | Potential for the manometer port being blocked rendering the manometer non-functional. | Class I | Ambu Inc. |
| Jul 8, 2025 | BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions | Infusion pump module used with compatible pump infusion sets may perform outside the establishe... | Class I | CareFusion 303, Inc. |
| Jul 8, 2025 | BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, B... | Infusion pump module used with compatible pump infusion sets may perform outside the establishe... | Class I | CareFusion 303, Inc. |
| Jul 7, 2025 | Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, s... | Certain batches are being removed due to an increase in complaints received in which physicians e... | Class I | Boston Scientific Corporation |
| Jun 30, 2025 | DreamStation Auto CPAP. Non-Continuous Ventilator. | Devices may possess a programming error resulting in an incorrect device configuration. | Class I | Philips Respironics, Inc. |
| Jun 30, 2025 | DreamStation Auto. Non-Continuous Ventilator. | Devices may possess a programming error resulting in an incorrect device configuration. | Class I | Philips Respironics, Inc. |
| Jun 30, 2025 | DreamStation Auto BiPAP. Non-Continuous Ventilator. | Devices may possess a programming error resulting in an incorrect device configuration. | Class I | Philips Respironics, Inc. |
| Jun 26, 2025 | Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve... | Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fr... | Class I | Hamilton Medical AG |
| Jun 23, 2025 | Automated Impella Controller (AIC), used in left heart support blood pump, in... | A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when ... | Class I | Abiomed, Inc. |
| Jun 23, 2025 | Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number:... | Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking... | Class I | Thoratec LLC |
| Jun 23, 2025 | Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/... | Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking... | Class I | Thoratec LLC |
| Jun 20, 2025 | Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2 | Certain Spectrum infusion pumps may have an incorrect version of software. | Class I | Baxter Healthcare Corporation |
| Jun 20, 2025 | Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX | Certain Spectrum infusion pumps may have an incorrect version of software. | Class I | Baxter Healthcare Corporation |
| Jun 17, 2025 | i-view video laryngoscope. Model Number: 8008000. The i-view video laryng... | Potential for faulty devices as a result of depleted batteries. | Class I | Intersurgical Inc |
| Jun 16, 2025 | SafeStar 90 Plus Filter. Bidirectionally breathing system filter. | Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filt... | Class I | Draeger, Inc. |
| Jun 16, 2025 | HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter. | Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filt... | Class I | Draeger, Inc. |
| Jun 16, 2025 | SafeStar 60A Plus Filter. Bidirectionally breathing system filter. | Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filt... | Class I | Draeger, Inc. |
| Jun 16, 2025 | SafeStar 55 Plus Filter. Bidirectionally breathing system filter. | Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filt... | Class I | Draeger, Inc. |
| Jun 3, 2025 | Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021Z... | A mechanical defect on a printed circuit board (PCB) as a result of PCB separating process. This... | Class I | Hamilton Medical AG |
| Jun 3, 2025 | Bravo CF capsule delivery device, designed to place and attach a pH monitorin... | It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead ... | Class I | Given Imaging Ltd. |
| May 30, 2025 | Servo-n Ventilator System. Model Number: 6694800. | Potential for inaccurate measurement of the patient circuit compliance during the patient circuit... | Class I | Maquet Critical Care AB |
| May 30, 2025 | Servo-u MR Ventilator System. Model Number: 6888800. | Potential for inaccurate measurement of the patient circuit compliance during the patient circuit... | Class I | Maquet Critical Care AB |
| May 30, 2025 | Hillrom Q-Link 13 component, Product Code 3156509, used with the following Mo... | The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook u... | Class I | Baxter Healthcare Corporation |
| May 30, 2025 | Hillrom LikoScale component, Product Code 3156232, used with the following a... | The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook u... | Class I | Baxter Healthcare Corporation |
| May 30, 2025 | Servo-u Ventilator System. Model Number: 6688600. | Potential for inaccurate measurement of the patient circuit compliance during the patient circuit... | Class I | Maquet Critical Care AB |
| May 23, 2025 | MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and fil... | Lack of sterility assurance. | Class I | Integra LifeSciences Corp. (NeuroSciences) |
| May 22, 2025 | Extended Tip Applicator, 15 CM, Box of 5. | Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assur... | Class I | Integra LifeSciences Corp. (NeuroSciences) |
| May 22, 2025 | Extended Tip Applicator 8CM, Box of 1. | Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assur... | Class I | Integra LifeSciences Corp. (NeuroSciences) |
| May 22, 2025 | Extended Tip Applicator, 8CM, Box of 5. | Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assur... | Class I | Integra LifeSciences Corp. (NeuroSciences) |
| May 21, 2025 | Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT... | Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which m... | Class I | Covidien |
| May 15, 2025 | Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnosti... | Cook Medical identified that catheters supplied in the affected device lots may experience tip se... | Class I | Cook Incorporated |
| May 15, 2025 | Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700... | The impacted tape was manufactured with incorrect information on the tape. Incorrect values are p... | Class I | SunMed Holdings, LLC |
| May 14, 2025 | Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalo... | due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the... | Class I | Edwards Lifesciences, LLC |
| May 14, 2025 | Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalo... | due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the... | Class I | Edwards Lifesciences, LLC |
| May 14, 2025 | Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalo... | due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the... | Class I | Edwards Lifesciences, LLC |
| May 14, 2025 | Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannul... | due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the... | Class I | Edwards Lifesciences, LLC |
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.