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 |
|---|---|---|---|---|
| Sep 3, 2025 | Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K1... | The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K1... | The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associ... | The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 51... | Systems may not perform as intended due to the deterioration of certain internal components (the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers... | Systems may not perform as intended due to the deterioration of certain internal components (the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associa... | Systems may not perform as intended due to the deterioration of certain internal components (the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005... | Systems may not perform as intended due to the deterioration of certain internal components (the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510... | Systems may not perform as intended due to the deterioration of certain internal components (the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Aug 29, 2025 | Getinge 88-Series Washer- Disinfector. Model Number: 88-5. | Potential for device to overheat during operation if the circulation pressure calibration was not... | Class II | Getinge Disinfection Ab |
| Aug 26, 2025 | Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P. | Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the curre... | Class II | OSSTEM Implant Co., Ltd. |
| Aug 26, 2025 | Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS. | Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the curre... | Class II | OSSTEM Implant Co., Ltd. |
| Aug 26, 2025 | Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS. | Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the curre... | Class II | OSSTEM Implant Co., Ltd. |
| Aug 18, 2025 | AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R. | Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAG... | Class II | Aesculap AG |
| Aug 18, 2025 | AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R. | Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAG... | Class II | Aesculap AG |
| Aug 13, 2025 | Change Healthcare Radiology Solutions software version 14.2.2 | Due to software issue, radiology reports may not be fully displayed when viewing. | Class II | CHANGE HEALTHCARE CANADA COMPANY |
| Aug 11, 2025 | Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use ... | Their is the potential for weak staining which may result in false negative CD20 identification. | Class II | Agilent Technologies Denmark ApS |
| Aug 11, 2025 | Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use ... | Their is the potential for weak staining which may result in false negative CD20 identification. | Class II | Agilent Technologies Denmark ApS |
| Aug 11, 2025 | Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use ... | Their is the potential for weak staining which may result in false negative CD20 identification. | Class II | Agilent Technologies Denmark ApS |
| Aug 8, 2025 | RayStation with the following product descriptions: 1. RayStation 2023B, ... | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's i... | Class II | RAYSEARCH LABORATORIES AB |
| Aug 8, 2025 | RayStation with the following product descriptions: 1. RayStation 7, Soft... | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's i... | Class II | RAYSEARCH LABORATORIES AB |
| Aug 8, 2025 | RayStation with the following product descriptions: 1. RayStation 12A, So... | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's i... | Class II | RAYSEARCH LABORATORIES AB |
| Aug 8, 2025 | RayStation with the following product descriptions: 1. RayStation 10B, So... | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's i... | Class II | RAYSEARCH LABORATORIES AB |
| Aug 8, 2025 | RayStation with the following product descriptions: 1. RayStation 6 Servi... | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's i... | Class II | RAYSEARCH LABORATORIES AB |
| Aug 8, 2025 | RayStation with the following product descriptions: 1. RayStation 9B, Sof... | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's i... | Class II | RAYSEARCH LABORATORIES AB |
| Aug 8, 2025 | RayStation with the following product descriptions: 1. RayStation 11A, So... | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's i... | Class II | RAYSEARCH LABORATORIES AB |
| Aug 8, 2025 | Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.9... | Vital sign monitoring instrument may trigger an error message during blood pressures measurement... | Class II | Schiller, Ag |
| Aug 8, 2025 | IntelliSpace Cardiovascular, Software 8.0.0.4. | Software issue that results in the display of outdated information. | Class II | Philips Medical Systems Nederland B.V. |
| Aug 8, 2025 | RayStation with the following product descriptions: 1. RayStation 8B, Sof... | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's i... | Class II | RAYSEARCH LABORATORIES AB |
| Aug 8, 2025 | RayStation with the following product descriptions: 1. RayStation 11B, So... | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's i... | Class II | RAYSEARCH LABORATORIES AB |
| Aug 7, 2025 | FloPatch FP120, REF: FP120-FOT01-005 | Flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-0... | Class III | Flosonics Medical (R/A 1929803 ONTARIO CORP.) |
| Aug 1, 2025 | Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labele... | Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Aug 1, 2025 | Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.... | Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Aug 1, 2025 | Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R... | Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jul 31, 2025 | LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/Ti... | Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security ... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 30, 2025 | Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introdu... | Units may have been packaged with an incorrect pouch label, which lists the reference number and ... | Class II | Contract Medical International GmbH |
| Jul 30, 2025 | IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT1... | Dental implants were imported under temperature and storage conditions that do not comply with th... | Class II | S.I.N. Implant System Ltda |
| Jul 28, 2025 | Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model... | Due to a weld breakage between the pin and inserter holder of the Inserter Adapter. | Class II | ORTOMA AB |
| Jul 22, 2025 | OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical ... | The potential for unsterilized product within finished product labeled as sterile. | Class II | LUMENIS, LTD. |
| Jul 21, 2025 | Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Mode... | The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall. | Class II | B.Braun Medical S.A.S. |
| Jul 16, 2025 | TOPS Inserter, part of the TOPS System Instrument Set used for implantation o... | Potential for missing pins at tip of inserter. | Class II | PREMIA SPINE LTD |
| Jul 15, 2025 | Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15. | Inconsistent size terminology and color coding used on labeling | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 15, 2025 | Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04. | Inconsistent size terminology and color coding used on labeling | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 14, 2025 | 3mensio Workstation (Vascular Fenestrated) software | When fenestrated analysis with clock measurements is started in diagnostic bioimaging software (i... | Class II | PIE Medical Imaging B.V. |
| Jul 11, 2025 | BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309U | Laryngoscope handles may not illuminate as intended. | Class I | Flexicare Medical (Dongguan) Ltd. |
| Jul 11, 2025 | BritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac 1... | Laryngoscope handles may not illuminate as intended. | Class I | Flexicare Medical (Dongguan) Ltd. |
| Jul 11, 2025 | Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0... | Laryngoscope handles may not illuminate as intended. | Class I | Flexicare Medical (Dongguan) Ltd. |
| Jul 11, 2025 | BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and ... | Laryngoscope handles may not illuminate as intended. | Class I | Flexicare Medical (Dongguan) Ltd. |
| Jul 11, 2025 | BritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415U | Laryngoscope handles may not illuminate as intended. | Class I | Flexicare Medical (Dongguan) Ltd. |
| Jul 11, 2025 | BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-011... | Laryngoscope handles may not illuminate as intended. | Class I | Flexicare Medical (Dongguan) Ltd. |
| Jul 10, 2025 | Multi Joystick R-net. Electrical wheelchair component. | Devices with firmware versions 2.3 and lower may experience timing variations between software ta... | Class I | mo-Vis BVBA |
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.