Browse Device Recalls
35,653 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,653 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 35,653 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Feb 18, 2025 | GE Healthcare Revolution Apex Plus, 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 Elite, 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 17, 2025 | Initiation 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-T... | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Initiation 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-T... | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | 18 Coated Super Tampons; Model Number: FG-TMP-REF00180000; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive saf... | Increased risk for valve housing detachment causing leakage. | Class II | B Braun Medical Inc |
| Feb 17, 2025 | Regular Flow Bundle; Model Number: FG-BNDL-PC-REFRF; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | 9 Coated Regular and 9 Nude Regular Tampons; Model Number: FG-TMP-REF09000900; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Refill 36 Coated Regular Tampons; Model Number: FG-TMP-MM-REF36000000; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Refill 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-REF09090909; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | All in One Bundle; Model Number: FG-BNDL-PC-REFAIO; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | 9 Coated Regular and 9 Coated Super Tampons; Model Number: FG-TMP-REF09090000; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Microstream Instructions for Use and Part Number used with - Product Descript... | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... | Class II | Oridion Medical 1987 Ltd. |
| Feb 17, 2025 | Initiation 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-M... | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | 9 Coated Regular Tampons and 9 Nude Regular Tampons; Model Number: FG-TMP-RE... | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Refill 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-M... | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Microstream Instructions for Use and Part Number used with - Product Descript... | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... | Class II | Oridion Medical 1987 Ltd. |
| Feb 17, 2025 | Microstream Instructions for Use and Part Number used with - Product Descript... | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... | Class II | Oridion Medical 1987 Ltd. |
| Feb 17, 2025 | Refill 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-REFAIO; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Microstream Instructions for Use and Part Number used with - Product Descript... | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... | Class II | Oridion Medical 1987 Ltd. |
| Feb 17, 2025 | Microstream Instructions for Use and Part Number used with - Product Descript... | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... | Class II | Oridion Medical 1987 Ltd. |
| Feb 17, 2025 | Refill 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-M... | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | 9 Coated Super Tampons and 9 Nude Super Tampons; Model Number: FG-TMP-RET000... | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Refill 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-REFRF; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | 18 Coated Regular Tampons; Model Number: FG-TMP-REF18000000; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Microstream Instructions for Use and Part Number used with - Product Descript... | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... | Class II | Oridion Medical 1987 Ltd. |
| Feb 17, 2025 | Initiation 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-IBHF; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Microstream Instructions for Use and Part Number used with - Product Descript... | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... | Class II | Oridion Medical 1987 Ltd. |
| Feb 17, 2025 | Initiation 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-IBAIO; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Initiation 36 Coated Super Tampons; Model Number: FG-TMP-MM-IB00360000; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Trial Tampon Box; Model Number: FG-TMP-REF04050504; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Initiation 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-IBRF; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Heavy Flow Bundle; Model Number: FG-BNDL-PC-REFHF; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Microstream Instructions for Use and Part Number used with - Product Descript... | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... | Class II | Oridion Medical 1987 Ltd. |
| Feb 17, 2025 | Refill 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-RE... | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Refill 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-REFHF; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Microstream Instructions for Use and Part Number used with - Product Descript... | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... | Class II | Oridion Medical 1987 Ltd. |
| Feb 17, 2025 | Refill 36 Coated Super Tampons; Model Number: FG-TMP-MM-REF00360000; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Initiation 36 Coated Regular Tampons; Model Number: FG-TMP-MM-IB36000000; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | 9 Coated Super and 9 Nude Super Tampons; Model Number: FG-TMP-REF00090009; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Initiation 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-IB09090909; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
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.