Browse Device Recalls
35,290 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,290 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 35,290 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 25, 2025 | Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-0... | There is a potential for blister seals on the product to present a bubble on the seal area of the... | Class II | Stryker Corporation |
| Feb 25, 2025 | Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 a... | There is a potential for blister seals on the product to present a bubble on the seal area of the... | Class II | Stryker Corporation |
| Feb 25, 2025 | Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 540... | There is a potential for blister seals on the product to present a bubble on the seal area of the... | Class II | Stryker Corporation |
| Feb 25, 2025 | Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and... | There is a potential for blister seals on the product to present a bubble on the seal area of the... | Class II | Stryker Corporation |
| Feb 25, 2025 | Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-2... | There is a potential for blister seals on the product to present a bubble on the seal area of the... | Class II | Stryker Corporation |
| Feb 25, 2025 | Zenition 70. Product Code 718133. The devices are used for radiological guida... | A wireless foot switch pedal may get stuck in the active position when the user releases the peda... | Class II | Philips North America Llc |
| Feb 25, 2025 | Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S | There is a potential for blister seals on the product to present a bubble on the seal area of the... | Class II | Stryker Corporation |
| Feb 25, 2025 | Baxter Mobile column TruSystem 7500 U, Product Code 1730720 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-0... | There is a potential for blister seals on the product to present a bubble on the seal area of the... | Class II | Stryker Corporation |
| Feb 25, 2025 | Baxter Stationary column TruSystem 7500 U, Product Code 1730731 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 a... | There is a potential for blister seals on the product to present a bubble on the seal area of the... | Class II | Stryker Corporation |
| Feb 25, 2025 | Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Baxter Operating table column TS7500 MOBIUS, Product Code 1704695 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or ... | The air bladders inside the mattress may move out of position when the head of the bed is elevate... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Baxter TruSystem 7500 Hybrid (FC), Product Code 1854085 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-21... | There is a potential for blister seals on the product to present a bubble on the seal area of the... | Class II | Stryker Corporation |
| Feb 25, 2025 | Baxter TruSystem 7500 Hybrid Plus (SC), Product Code 1854088 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Baxter Floor mounting column TruSystem 7500, Product Code 1717021 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Baxter Floor mounting column TS 7500 U, Product Code 1730732 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Baxter Mobile column TruSystem 7500, Product Code 1717023 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 24, 2025 | Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint... | Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and b... | Class II | Checkpoint Surgical Inc |
| Feb 24, 2025 | COR Disposable Kit, 8 mm. Cartilage Transplant System. | Device is missing the pin in the graft loader component. | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Feb 24, 2025 | COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System. | Device is missing the pin in the graft loader component. | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Feb 24, 2025 | Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007 | Single-use battery-powered blood pressure monitor, for use on neonates and infants, due to vibrat... | Class II | PYRAMES INC |
| Feb 24, 2025 | Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint... | Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and b... | Class II | Checkpoint Surgical Inc |
| Feb 20, 2025 | BD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 Conne... | Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instr... | Class II | BD SWITZERLAND SARL |
| Feb 20, 2025 | Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet... | The A549 human cell target (human cells for sample adequacy control) may give a late Ct value. | Class II | Microbiologics Inc |
| Feb 20, 2025 | Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory S... | The RSV target may give a late Ct value and could potentially not pass QC. | Class II | Microbiologics Inc |
| Feb 20, 2025 | IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: ... | IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and n... | Class II | Omnicell, Inc. |
| Feb 20, 2025 | Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device,... | The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on th... | Class II | Orthofix U.S. LLC |
| Feb 19, 2025 | GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numb... | There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-... | Class II | GE Healthcare |
| Feb 19, 2025 | VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9... | When following a specific less typical workflow in which the user remeasures using the ultrasound... | Class II | Merge Healthcare, Inc. |
| Feb 19, 2025 | VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: ... | When following a specific less typical workflow in which the user remeasures using the ultrasound... | Class II | Merge Healthcare, Inc. |
| Feb 19, 2025 | GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 202229... | There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-... | Class II | GE Healthcare |
| Feb 19, 2025 | GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 203... | There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-... | Class II | GE Healthcare |
| Feb 19, 2025 | GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077... | There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-... | Class II | GE Healthcare |
| Feb 19, 2025 | Wayson Hydrocolloid Models: 1) Model Number: CUR5103, DBD-BNDG,WTRPRF,HYDRCL... | There is a potential for the sterility of the device to be compromised. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 19, 2025 | VERICIS, Merge Cardio, Model/Catalog Number: Version 11.x, Software Version: ... | When following a specific less typical workflow in which the user remeasures using the ultrasound... | Class II | Merge Healthcare, Inc. |
| Feb 19, 2025 | MIM software; System, Image Processing, Radiological | In situations where two images with differing Fields of View (FOV) complete an image fusion, an i... | Class II | MIM Software Inc |
| Feb 19, 2025 | GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001;... | There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-... | Class II | GE Healthcare |
| Feb 19, 2025 | Wayson Hydrocolloid Models: 1) MJ BANDAGE HYDROCOLLOID HEEL OVAL 6CT, Model ... | There is a potential for the sterility of the device to be compromised. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 19, 2025 | Lazervida 10W diode laser cutter and engraver with Lazervida shield. | Lazervida 10W Diode Laser Engraver does not fully meet current Federal performance standards in ... | Class II | Flux Technology Inc. |
| Feb 19, 2025 | Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.... | When following a specific less typical workflow in which the user remeasures using the ultrasound... | Class II | Merge Healthcare, Inc. |
| Feb 19, 2025 | VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: ... | When following a specific less typical workflow in which the user remeasures using the ultrasound... | Class II | Merge Healthcare, Inc. |
| Feb 18, 2025 | GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed | GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex ... | Class II | GE Medical Systems, LLC |
| Feb 18, 2025 | GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed | GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex ... | Class II | GE Medical Systems, LLC |
| Feb 18, 2025 | GE Healthcare Revolution CT, System, X-ray, Tomography, Computed | GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex ... | Class II | GE Medical Systems, LLC |
| Feb 18, 2025 | GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed | GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex ... | Class II | GE Medical Systems, LLC |
| Feb 18, 2025 | GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed | GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex ... | Class II | GE Medical Systems, 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.