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 |
|---|---|---|---|---|
| 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 Trial Tampon Box; Model Number: FG-TMP-MM-IB09090909; | 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 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 | 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 | 18 Coated Regular Tampons; Model Number: FG-TMP-REF18000000; | 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 | 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 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 | 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 14, 2025 | Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 12... | A problem was discovered during the scanning process of the outer carton label because of an inco... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Feb 14, 2025 | Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13... | A problem was discovered during the scanning process of the outer carton label because of an inco... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Feb 14, 2025 | Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 1... | A problem was discovered during the scanning process of the outer carton label because of an inco... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Feb 10, 2025 | Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1 | Under certain circumstances, it can occur that patient records from unrelated individuals are aut... | Class II | Brainlab AG |
| Feb 7, 2025 | Bodor's I series laser cutting machine. | The Bodor i Series products fail to meet certain applicable Federal standards, 21 CFR 1040.10(f)(... | Class II | Jinan Bodor Cnc Machine Co Ltd |
| Feb 5, 2025 | IntelePACS (Image Fusion Module) - InteleViewer | A software application that receives digital images and data from various sources has a bug in sp... | Class II | INTELERAD MEDICAL SYSTEMS INCORPORATED |
| Jan 31, 2025 | Optima MR360, NMRI system | For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute a... | Class II | GE Healthcare (China) Co., Ltd. |
| Jan 31, 2025 | SIGNA MR380, NMRI system, Non-US Only | For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute a... | Class II | GE Healthcare (China) Co., Ltd. |
| Jan 31, 2025 | SIGNA MR355, SIGNA MR360, NMRI system | For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute a... | Class II | GE Healthcare (China) Co., Ltd. |
| Jan 31, 2025 | SIGNA Creator, SIGNA Explorer, NMRI systems | For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute a... | Class II | GE Healthcare (China) Co., Ltd. |
| Jan 31, 2025 | Brivo MR355, NMRI system | For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute a... | Class II | GE Healthcare (China) Co., Ltd. |
| Jan 30, 2025 | Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog N... | Firm became aware of software issues related to most recent firmware update which could result in... | Class II | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Jan 24, 2025 | Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device M... | Devices were distributed in the U.S. market without obtaining the required FDA premarket authoriz... | Class II | Guangzhou Pluslife Biotech Co., Ltd. |
| Jan 24, 2025 | Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid T... | Devices were distributed in the U.S. market without obtaining the required FDA premarket authoriz... | Class II | Guangzhou Pluslife Biotech Co., Ltd. |
| Jan 16, 2025 | Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... | Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... | Class II | RAYSEARCH LABORATORIES AB |
| Jan 16, 2025 | Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... | Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... | Class II | RAYSEARCH LABORATORIES AB |
| Jan 16, 2025 | Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... | Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... | Class II | RAYSEARCH LABORATORIES AB |
| Jan 16, 2025 | Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... | Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... | Class II | RAYSEARCH LABORATORIES AB |
| Jan 16, 2025 | Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning Sy... | Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... | Class II | RAYSEARCH LABORATORIES AB |
| Jan 16, 2025 | Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning Sys... | Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... | Class II | RAYSEARCH LABORATORIES AB |
| Jan 16, 2025 | Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... | Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... | Class II | RAYSEARCH LABORATORIES AB |
| Jan 16, 2025 | Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... | Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... | Class II | RAYSEARCH LABORATORIES AB |
| Jan 16, 2025 | Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning Sy... | Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... | Class II | RAYSEARCH LABORATORIES AB |
| Jan 16, 2025 | Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... | Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... | Class II | RAYSEARCH LABORATORIES AB |
| Jan 16, 2025 | Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... | Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... | Class II | RAYSEARCH LABORATORIES AB |
| Jan 15, 2025 | ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135. | Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the... | Class II | TERRAGENE S.A. |
| Jan 13, 2025 | Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027. | Possibility of the patient falling from the table related to the mattress used on the patient table. | Class I | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281... | Possibility of the patient falling from the table related to the mattress used on the patient table. | Class I | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Allura Xper FD20/20; Catalog numbers: 722038 | Possibility of the patient falling from the table related to the mattress used on the patient table. | Class I | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY). | Possibility of the patient falling from the table related to the mattress used on the patient table. | Class I | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Allura Xper FD10C; Catalog number: 722001 | Possibility of the patient falling from the table related to the mattress used on the patient table. | Class I | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026, | Possibility of the patient falling from the table related to the mattress used on the patient table. | Class I | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Allura Xper FD20/10; Catalog numbers: 722029 | Possibility of the patient falling from the table related to the mattress used on the patient table. | Class I | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY). | Possibility of the patient falling from the table related to the mattress used on the patient table. | Class I | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY). | Possibility of the patient falling from the table related to the mattress used on the patient table. | Class I | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236. | Possibility of the patient falling from the table related to the mattress used on the patient table. | Class I | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
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.