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.

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DateProductReasonClassFirm
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.