Browse Device Recalls
2,049 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,049 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 2,049 FDA device recalls in N/A.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 21, 2025 | GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 19, 2025 | Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, P... | Medical device software marketed without FDA clearance . | Class II | Spectrum Medical Ltd. |
| Mar 19, 2025 | Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological... | Medical device software marketed without FDA clearance . | Class II | Spectrum Medical Ltd. |
| Mar 14, 2025 | Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038 | A potential weakness has been identified in the probe body, so that, in a specific production bat... | Class II | ESAOTE S.P.A. |
| Mar 14, 2025 | DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002) | Potential of compromised compatibility resulting in influence on the positioning of the reference... | Class II | Pro-Med Instruments Gmbh |
| Mar 12, 2025 | Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter ... | Due to manufacturing issues there is a potential for the catheter sheath to detach. | Class I | Conavi Medical Inc. |
| Mar 5, 2025 | stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, pack... | Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... | Class II | Tornier S.A.S. |
| Mar 5, 2025 | stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Art... | Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... | Class II | Tornier S.A.S. |
| Mar 5, 2025 | stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE20... | Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... | Class II | Tornier S.A.S. |
| Mar 5, 2025 | stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Ste... | Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... | Class II | Tornier S.A.S. |
| Mar 5, 2025 | stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in... | Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... | Class II | Tornier S.A.S. |
| Mar 5, 2025 | stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total... | Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... | Class II | Tornier S.A.S. |
| Mar 5, 2025 | stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total... | Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... | Class II | Tornier S.A.S. |
| Mar 5, 2025 | stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, pa... | Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... | Class II | Tornier S.A.S. |
| Mar 5, 2025 | stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packa... | Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... | Class II | Tornier S.A.S. |
| Mar 3, 2025 | Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Ste... | Five complaints received where surgeon was unable to remove and/or connect the inserter with the ... | Class II | ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY |
| 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 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Regular Flow Bundle; Model Number: FG-BNDL-PC-REFRF; | 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 | 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 | 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 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 | 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 | 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 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 | 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 | 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 | Heavy Flow Bundle; Model Number: FG-BNDL-PC-REFHF; | 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 | Trial Tampon Box; Model Number: FG-TMP-REF04050504; | 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 | 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 | 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. |
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.