Browse Device Recalls
3,428 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,428 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 3,428 FDA device recalls — Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 16, 2024 | MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric... | MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recall... | Class I | Avanos Medical, Inc. |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult ... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, R... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, A... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Dete... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult ... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult ... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, withou... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 9, 2024 | VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-010... | The bonded spiral wrap may detach before or during ventilation due to a manufacturing issue. Det... | Class I | Ventec Life Systems, Inc. |
| Jan 3, 2024 | 1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Comm... | Due to software and controller systems that results in unexpected pump start or pump stop. | Class I | Thoratec Corp. |
| Dec 29, 2023 | EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230... | GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun... | Class I | Datex-Ohmeda, Inc. |
| Dec 29, 2023 | EVair air compressor, model numbers: M1230849 and M1230847 | GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun... | Class I | Datex-Ohmeda, Inc. |
| Dec 29, 2023 | EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002 | GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun... | Class I | Datex-Ohmeda, Inc. |
| Dec 28, 2023 | Cardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit... | The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have r... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 60 mL Syringe Luer-Lock Tip Soft Pack, REF 1186000... | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777 | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit C... | The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have r... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack, REF 1182000777 | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For U... | The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have r... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 6 mL Syringe Luer-Lock Tip Soft Pack, REF 1180600777 | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 12 mL Syringe Luer-Lock Tip Soft Pack, REF 1181200... | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit ... | The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have r... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, R... | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection S... | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 35 mL Syringe Luer-Lock Tip Soft Pack, REF 1183500777 | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 3 mL Purple Enteral Syringe with Enfit Connection S... | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
| Dec 27, 2023 | Impella catheters - Intravascular micro axial blood pumps that support a pati... | IFU has been updated to include warnings about the risk of the inlet perforating through the myoc... | Class I | Abiomed, Inc. |
| Dec 26, 2023 | GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M... | GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ... | Class I | Wipro GE Healthcare Private Ltd. |
| Dec 26, 2023 | GE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lulla... | GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ... | Class I | Wipro GE Healthcare Private Ltd. |
| Dec 26, 2023 | GE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit, Part Numbers: ... | GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ... | Class I | Wipro GE Healthcare Private Ltd. |
| Dec 26, 2023 | GE Healthcare Care Plus Hood Door FRU kit, Part Numbers: 6600-0082-850, 6600-... | GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ... | Class I | Wipro GE Healthcare Private Ltd. |
| Dec 26, 2023 | GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 100... | GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ... | Class I | Wipro GE Healthcare Private Ltd. |
| Dec 26, 2023 | GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169... | GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ... | Class I | Wipro GE Healthcare Private Ltd. |
| Dec 22, 2023 | Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO | Sterility assurance for saline included in surgical kits cannot be guaranteed. | Class I | Windstone Medical Packaging, Inc. |
| Dec 22, 2023 | Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO | Sterility assurance for saline included in surgical kits cannot be guaranteed. | Class I | Windstone Medical Packaging, Inc. |
| Dec 22, 2023 | Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO | Sterility assurance for saline included in surgical kits cannot be guaranteed. | Class I | Windstone Medical Packaging, Inc. |
| Dec 22, 2023 | Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO | Sterility assurance for saline included in surgical kits cannot be guaranteed. | Class I | Windstone Medical Packaging, Inc. |
| 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 |
| 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 19, 2023 | smiths medical Medfusion Model 4000 syringe pump | Medfusion Model 4000 syringe infusion pumps, with the following software versions, may have the f... | Class I | Smiths Medical ASD Inc. |
| Dec 19, 2023 | smiths medical Medfusion Model 3500 Syringe pump | Medfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. D... | Class I | Smiths Medical ASD Inc. |
| Dec 18, 2023 | regard Operative LAP, Item Number 800943001; surgical convenience kit | Surgical convenience kits were manufactured with a component which was subsequently recalled by N... | Class I | ROi CPS LLC |
| Dec 15, 2023 | BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12... | Detector may unexpectedly fall due to a component failure. If the detector is positioned below ce... | Class I | Philips North America |
| Dec 15, 2023 | BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478... | Detector may unexpectedly fall due to a component failure. If the detector is positioned below ce... | Class I | Philips North America |
| Dec 15, 2023 | BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 8824... | Detector may unexpectedly fall due to a component failure. If the detector is positioned below ce... | Class I | Philips North America |
| Dec 13, 2023 | Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit | Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If th... | Class I | Maquet Cardiovascular, LLC |
| Dec 13, 2023 | Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection | Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If th... | Class I | Maquet Cardiovascular, LLC |
| Dec 12, 2023 | High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx On... | Due to an assembly error within the breathing circuit, their pressure output of the breathing cir... | Class I | Percussionaire 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.