Browse Device Recalls
3,276 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,276 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 3,276 FDA device recalls in 2024.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 20, 2024 | Alinity m System, Part Number: 08N53-002 | The Alinity m System camera detects whether tubes are "capped." If the camera detects a cap and t... | Class II | Abbott Molecular, Inc. |
| Mar 20, 2024 | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | ZPLP Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Nonsterile- Indicat... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indica... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plat... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | ZPLP Distal Lateral Fibular Plate, Left, 14 Holes, 210 MM, Sterile- Indicated... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | ZPLP Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Nonsterile- Indica... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | 24K Premium Lense, Distributed by Updream Inc. | Contact lenses recalled due to potential bacterial contamination. | Class II | Ontact Inc |
| Mar 19, 2024 | Medtronic Venous Cannulae: a) DLP¿ 20 Fr. Malleable Single Stage Venous Ca... | Potential for unsealed sterile packing. | Class II | Medtronic Perfusion Systems |
| Mar 19, 2024 | Medtronic Arterial Cannulae packaged as: a) DLP¿ Curved Metal Tip Arterial... | Potential for unsealed sterile packing. | Class II | Medtronic Perfusion Systems |
| Mar 19, 2024 | Trilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatri... | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... | Class I | Philips Respironics, Inc. |
| Mar 19, 2024 | Garbin EVO, all software versions except 1.05.06.00. Ventilator for pediatric... | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... | Class I | Philips Respironics, Inc. |
| Mar 19, 2024 | Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediat... | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... | Class I | Philips Respironics, Inc. |
| Mar 19, 2024 | Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP¿ 9 Ga (11 ... | Potential for unsealed sterile packing. | Class II | Medtronic Perfusion Systems |
| Mar 19, 2024 | Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pedia... | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... | Class I | Philips Respironics, Inc. |
| Mar 19, 2024 | Medtronic Clearview Blower/Mister, Model Number 22120 | Potential for unsealed sterile packing. | Class II | Medtronic Perfusion Systems |
| Mar 19, 2024 | TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, ... | Nail system contains an out of specification driver-socket which could result in inability to pi... | Class II | TriMed Inc. |
| Mar 19, 2024 | Medtronic Tourniquet Sets: a) DLP¿ 5.5 in (14.0 cm) Tourniquet Kit, Model ... | Potential for unsealed sterile packing. | Class II | Medtronic Perfusion Systems |
| Mar 19, 2024 | Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric ... | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... | Class I | Philips Respironics, Inc. |
| Mar 19, 2024 | Medtronic I.M.A. Cannulae: DLP¿ 1 mm Arteriotomy Cannula, Model Number 31001 | Potential for unsealed sterile packing. | Class II | Medtronic Perfusion Systems |
| Mar 19, 2024 | LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatr... | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... | Class I | Philips Respironics, Inc. |
| Mar 19, 2024 | TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, ... | Nail system contains an out of specification driver-socket which could result in inability to pi... | Class II | TriMed Inc. |
| Mar 19, 2024 | Medtronic Suction Tubes: a) DLP¿ Suction Tube 6-Fr. Shaft with Frazier Tip,... | Potential for unsealed sterile packing. | Class II | Medtronic Perfusion Systems |
| Mar 19, 2024 | Medtronic DLP Coronary Ostial Cannulae, Model Number 30050 | Potential for unsealed sterile packing. | Class II | Medtronic Perfusion Systems |
| Mar 19, 2024 | Medtronic Cardioplegia Adapters: a) DLP¿ 1.8 m (6 ft) Pressure Monitoring ... | Potential for unsealed sterile packing. | Class II | Medtronic Perfusion Systems |
| Mar 19, 2024 | Medtronic Left Heart Vent Catheters: a) DLP¿ Intracardiac Sump 20 Fr, Mode... | Potential for unsealed sterile packing. | Class II | Medtronic Perfusion Systems |
| Mar 19, 2024 | Medtronic Intracoronary Shunts: a) ClearView¿ 1.00 mm Intracoronary Shunt,... | Potential for unsealed sterile packing. | Class II | Medtronic Perfusion Systems |
| Mar 19, 2024 | Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ve... | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... | Class I | Philips Respironics, Inc. |
| Mar 19, 2024 | Medtronic Vessel Cannulae: a) DLP¿ 2 mm Vessel Cannula Blunt Tip, Model ... | Potential for unsealed sterile packing. | Class II | Medtronic Perfusion Systems |
| Mar 19, 2024 | Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Mode... | Potential for unsealed sterile packing. | Class II | Medtronic Perfusion Systems |
| Mar 18, 2024 | DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 5-UP PG- Indicated for use in a... | XXX | Class II | Angiodynamics, Inc. |
| Mar 18, 2024 | DURAMAX STACKED TIP 24CM STR. BASIC KIT, 5-UP PG- Indicated for use in attain... | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... | Class II | Angiodynamics, Inc. |
| Mar 18, 2024 | GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems | GE HealthCare has become aware of the potential that adhesive material might not have been applie... | Class II | GE Medical Systems, SCS |
| Mar 18, 2024 | GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems | GE HealthCare has become aware of the potential that adhesive material might not have been applie... | Class II | GE Medical Systems, SCS |
| Mar 18, 2024 | DURAFLOW 2, 28CM STRAIGHT BASIC KIT, 1 per Bx PG-Indicated for use in attai... | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... | Class II | Angiodynamics, Inc. |
| Mar 18, 2024 | GE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems | GE HealthCare has become aware of the potential that adhesive material might not have been applie... | Class II | GE Medical Systems, SCS |
| Mar 18, 2024 | GE Healthcare Innova IGS 5, computed tomography x-ray system | GE HealthCare has become aware of the potential that adhesive material might not have been applie... | Class II | GE Medical Systems, SCS |
| Mar 18, 2024 | DURAFLOW 2, 24CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-... | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... | Class II | Angiodynamics, Inc. |
| Mar 18, 2024 | GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems | GE HealthCare has become aware of the potential that adhesive material might not have been applie... | Class II | GE Medical Systems, SCS |
| Mar 18, 2024 | DURAMAX STACKED TIP 28CM STR. BASIC KIT, 5-UP PG- Indicated for use in attain... | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... | Class II | Angiodynamics, Inc. |
| Mar 18, 2024 | DURAFLOW 2, 28CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-... | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... | Class II | Angiodynamics, Inc. |
| Mar 18, 2024 | DURAMAX STACKED TIP 32 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in a... | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... | Class II | Angiodynamics, Inc. |
| Mar 18, 2024 | DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in ... | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... | Class II | Angiodynamics, Inc. |
| Mar 18, 2024 | BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit- Indicated for use ... | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... | Class II | Angiodynamics, Inc. |
| Mar 18, 2024 | GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems | GE HealthCare has become aware of the potential that adhesive material might not have been applie... | Class II | GE Medical Systems, SCS |
| Mar 18, 2024 | LightStrike Blackout Curtains, Part numbers; 610-00008, 610-00009, 610-00019,... | Blackout curtains are no longer recommended as a protective barrier against UV/Ozone exposure to ... | Class II | XENEX Disinfection Services Inc. |
| Mar 18, 2024 | DURAFLOW 2, 55CM STRAIGHT BASIC KIT PG- Indicated for use in attaining Long... | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... | Class II | Angiodynamics, Inc. |
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.