Browse Device Recalls
2,260 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,260 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 2,260 FDA device recalls in 2021.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 19, 2021 | Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795090, 100... | Battery system data issue with the ultrasound system can intermittently cause a system shutdown, ... | Class II | Philips Ultrasound Inc |
| Aug 19, 2021 | Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 888157012... | Monoject 0.9% Sodium Chloride Flush Syringe Manufactured by Cardinal Health and placed into kits.... | Class I | Windstone Medical Packaging, Inc. |
| Aug 19, 2021 | Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100... | Battery system data issue with the ultrasound system can intermittently cause a system shutdown, ... | Class II | Philips Ultrasound Inc |
| Aug 18, 2021 | Scrip Creme All Purpose Lotion Intended for use in acoustic coupling of ultr... | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... | Class I | Scrip Inc |
| Aug 18, 2021 | CoLink Bone Graft Harvester, 8mm, Sterile, Disposable, REF G05 S1008 - Produc... | Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site. | Class II | In2bones USA, LLC |
| Aug 18, 2021 | COVENA PICC Sleeve | Marketed without FDA clearance | Class II | Queen Comfort Products lLC |
| Aug 18, 2021 | Scrip Ultrasound Gel Clear, 5L Intended for use in acoustic coupling of ultr... | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... | Class I | Scrip Inc |
| Aug 18, 2021 | Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP... | Software versions may result in sporadic problems causing scanning workflow interruptions and un... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 17, 2021 | EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160 | A gluing step was not performed during the manufacturing of the affected device's insertion tube.... | Class II | Olympus Corporation of the Americas |
| Aug 16, 2021 | BF-P180 EVIS EXERA II Bronchovideoscope, Model No. BF-P180 | The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... | Class II | Olympus Corporation of the Americas |
| Aug 16, 2021 | BF-XP160F EVIS EXERA Bronchovideoscope, Model No. BF-XP160F | The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... | Class II | Olympus Corporation of the Americas |
| Aug 16, 2021 | BF-Q180-AC EVIS EXERA II Bronchovideoscope, Model No. BF-Q180-AC | The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... | Class II | Olympus Corporation of the Americas |
| Aug 16, 2021 | MR MAGNETOM Systems with RT Image Suite with syngo MR VA20A, VA30A and VA31A... | Potential for data loss when using the contouring or patient marking workflow when editing a stru... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 16, 2021 | BF-P60 OES Bronchofiberscope, Model No. BF-P60 | The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... | Class II | Olympus Corporation of the Americas |
| Aug 16, 2021 | syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended... | Potential for data loss when using the contouring or patient marking workflow when editing a stru... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 16, 2021 | syngo.CT VA20A, VA30A and VA40A in: syngo.via RT Image Suite / Sim&Go SO... | Potential for data loss when using the contouring or patient marking workflow when editing a stru... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 16, 2021 | BF-N20 OES Bronchofiberscope, Model No. BF-N20 | The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... | Class II | Olympus Corporation of the Americas |
| Aug 16, 2021 | BF-1T60 OES Bronchofiberscope, Model No. BF-1T60 | The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... | Class II | Olympus Corporation of the Americas |
| Aug 16, 2021 | AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclu... | When deleting a previously entered custom isotope, the software deletes the isotope, but not the ... | Class II | Biodex Medical Systems, Inc. |
| Aug 16, 2021 | BF-XT160 EVIS EXERA Bronchovideoscope, Model No. BF-XT160 | The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... | Class II | Olympus Corporation of the Americas |
| Aug 16, 2021 | BF-3C40 OES Bronchofiberscope, Model No. BF-3C40 | The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... | Class II | Olympus Corporation of the Americas |
| Aug 16, 2021 | BF-1T180 EVIS EXERA II Bronchovideoscope, Model No. BF-1T180 | The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... | Class II | Olympus Corporation of the Americas |
| Aug 16, 2021 | Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusiv... | When deleting a previously entered custom isotope, the software deletes the isotope, but not the ... | Class II | Biodex Medical Systems, Inc. |
| Aug 16, 2021 | BF-XP60 OES Bronchofiberscope, Model No. BF-XP60 | The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... | Class II | Olympus Corporation of the Americas |
| Aug 13, 2021 | The Allura Xper series is intended for use on human patients to perform: "Va... | Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. Th... | Class II | Philips North America Llc |
| Aug 13, 2021 | Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The ... | Revised Instructions for Use: Potential for specimens from patients with high SARS-CoV-2 viral lo... | Class II | Quidel Corporation |
| Aug 13, 2021 | VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged | Blood collection tubes may experience a clotting issue. | Class II | Greiner Bio-One North America, Inc. |
| Aug 13, 2021 | Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137... | There is a potential for distal end of catheters to fracture and become detached. | Class I | IMPERATIVE CARE INC |
| Aug 13, 2021 | The Azurion series (within the limits of the used Operation Room table) are i... | Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. Th... | Class II | Philips North America Llc |
| Aug 13, 2021 | The Allura Xper series is intended for use on human patients to perform: "Vas... | Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. Th... | Class II | Philips North America Llc |
| Aug 12, 2021 | Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image proce... | A software anomaly exists in the Centricity Universal Viewer study management feature in which st... | Class II | GE Healthcare, LLC |
| Aug 12, 2021 | EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiP... | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... | Class I | AMTEC SALES Inc |
| Aug 11, 2021 | OctoStretch with Stretch Leveller - The combination of this products allows t... | Stretch Leveller has the potential to lose the function of maintaining a patient in the horizonta... | Class II | Hill-Rom, Inc. |
| Aug 11, 2021 | SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | FlexoStretch Model Number: 3156057 - The combination of this products allows ... | Stretch Leveller has the potential to lose the function of maintaining a patient in the horizonta... | Class II | Hill-Rom, Inc. |
| Aug 11, 2021 | Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for ... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia Elition S-a Magnetic Resonance Medical Electrical Systems indicated f... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for us... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indica... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated ... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Stretch Leveller Model Number: 3156200 - The combination of this products all... | Stretch Leveller has the potential to lose the function of maintaining a patient in the horizonta... | Class II | Hill-Rom, Inc. |
| Aug 11, 2021 | Ingenia Elition X-a Magnetic Resonance Medical Electrical Systems indicated f... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for u... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... | Class I | Red Medical Supplies |
| Aug 11, 2021 | EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... | Class I | Red Medical Supplies |
| Aug 11, 2021 | LikoStretch 1900 Model Number: 3156051 - The combination of this products all... | Stretch Leveller has the potential to lose the function of maintaining a patient in the horizonta... | Class II | Hill-Rom, Inc. |
| Aug 11, 2021 | Ingenia Ambition X- Magnetic Resonance Medical Electrical Systems indicated f... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | McKesson Lap Sponge, X-Ray Detectable 12"x 12", 5/pack, Sterile McKesson Par... | Manufacturer issued a recall due to an EO indicator color. The indicator should change from red t... | Class II | Cypress Medical Products LLC |
| Aug 11, 2021 | EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... | Class I | Red Medical Supplies |
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.