Browse Device Recalls
39,949 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,949 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 39,949 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 9, 2024 | First Source iQ Flex M. Portable cart and platform that supports an X-ray sys... | Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall ... | Class II | First Source Inc |
| May 9, 2024 | Syringe Tip Caps labeled as: 1) SOL-M Syringe Tip Cap, Blue, Model No. STC... | Products in distribution were found by FDA to be to be substantially different from the current c... | Class II | Sol-Millennium Medical Inc. |
| May 9, 2024 | Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syring... | Products in distribution were found by FDA to be to be substantially different from the current c... | Class II | Sol-Millennium Medical Inc. |
| May 9, 2024 | Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard... | Some of the devices may function incorrectly resulting in no temperature display or erratic tempe... | Class II | C.R. Bard Inc |
| May 9, 2024 | Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is par... | Ultrasound system has a bug in affected iOS software, which after DICOM export, can cause inaccur... | Class II | Echonous Inc |
| May 9, 2024 | Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempu... | Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the sam... | Class II | Remote Diagnostic Technologies Ltd. |
| May 9, 2024 | First Source Vision M. Portable cart and platform that supports an X-ray syst... | Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall ... | Class II | First Source Inc |
| May 9, 2024 | Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 1... | Products in distribution were found by FDA to be to be substantially different from the current c... | Class II | Sol-Millennium Medical Inc. |
| May 9, 2024 | Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffman... | The adjustment ring on the device may become loose resulting in the wire tension not being able t... | Class II | Stryker GmbH |
| May 9, 2024 | Syringes with Low Dead Space labeled as: a) SOL-M 1ml Slip Tip Syringe w/o... | Products in distribution were found by FDA to be to be substantially different from the current c... | Class II | Sol-Millennium Medical Inc. |
| May 9, 2024 | Syringes with Luer Slip Tips labeled as: 1) SOL-M 1ml Slip Tip Syringe w/o... | Products in distribution were found by FDA to be to be substantially different from the current c... | Class II | Sol-Millennium Medical Inc. |
| May 9, 2024 | Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syrin... | Products in distribution were found by FDA to be to be substantially different from the current c... | Class II | Sol-Millennium Medical Inc. |
| May 8, 2024 | Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US,... | System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, ... | Class I | Thoratec Corp. |
| May 8, 2024 | VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagno... | The results generated by the VITROS Immunodiagnostic Products Vitamin B12 Range Verifier Lot# 120... | Class III | Ortho-Clinical Diagnostics, Inc. |
| May 8, 2024 | MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Retur... | Reports of patient burns. | Class I | Megadyne Medical Products, Inc. |
| May 8, 2024 | BD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multitest 6-Color TBNK Kit... | Multitest with compromised raw material used to assess immune system status may result in flow cy... | Class II | Becton, Dickinson and Company, BD Biosciences |
| May 8, 2024 | Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare en... | There is a potential for the top cover of the hospital bed mattress to delaminate as a result of ... | Class II | Baxter Healthcare Corporation |
| May 7, 2024 | CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to... | Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may... | Class II | Integra LifeSciences Corp. |
| May 7, 2024 | BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 ... | Assays may produce false negative results due to decreased activity of the enzyme utilized in man... | Class II | Becton Dickinson & Co. |
| May 7, 2024 | CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for ga... | Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may... | Class II | Integra LifeSciences Corp. |
| May 7, 2024 | Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv. Hemostasis ... | Potential for an incomplete seal on the packaging tray. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 7, 2024 | CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the vent... | Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal tha... | Class II | Integra LifeSciences Corp. |
| May 7, 2024 | Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System... | Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss... | Class I | ICU Medical Inc |
| May 7, 2024 | Plum 360/A+ spare batteries. Item Number: SUB0000864. | Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss... | Class I | ICU Medical Inc |
| May 7, 2024 | Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & ... | Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss... | Class I | ICU Medical Inc |
| May 7, 2024 | CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intend... | CORI Surgical System with Real Intelligence Software exhibits an increased Marker Registration Er... | Class II | Blue Belt Technologies, Inc |
| May 7, 2024 | Medline ReNewal Reprocessed Covidien LigaSure Impact, Sealer/Divider, Nano-Co... | Potential for an incomplete seal on the packaging tray. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 7, 2024 | Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano... | Potential for an incomplete seal on the packaging tray. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 7, 2024 | Medline ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider, Na... | Potential for an incomplete seal on the packaging tray. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 6, 2024 | American Contract Systems Gyn Laparoscopy convenience kit | Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... | Class II | American Contract Systems, Inc. |
| May 6, 2024 | American Contract Systems Extremity convenience kit, American Contract System... | Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... | Class II | American Contract Systems, Inc. |
| May 6, 2024 | American Contract Systems Cataract Pack convenience kit | Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... | Class II | American Contract Systems, Inc. |
| May 6, 2024 | American Contract Systems Special Procedure Pack convenience kit | Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... | Class II | American Contract Systems, Inc. |
| May 6, 2024 | American Contract Systems Laparoscopy Litho Std Pack convenience kit and Amer... | Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... | Class II | American Contract Systems, Inc. |
| May 6, 2024 | American Contract Systems Biopsy Drape Pack convenience kit | Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... | Class II | American Contract Systems, Inc. |
| May 6, 2024 | American Contract Systems Hand Pack convenience kit | Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... | Class II | American Contract Systems, Inc. |
| May 6, 2024 | American Contract Systems Spine Pack convenience kit | Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... | Class II | American Contract Systems, Inc. |
| May 6, 2024 | NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA | Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrica... | Class II | NovaSignal Corp. |
| May 6, 2024 | NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2 | Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrica... | Class II | NovaSignal Corp. |
| May 3, 2024 | Ingenia 1.5T CX - Magnetic Resonance (MR) systems are Medical Electrical Sys... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Achieva 3.0T TX for PET Model Number (REF): 781479 | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems ind... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | ADVANTA VXT, 5X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | ADVANTA VXT, 7X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | Ingenia 1.5T S Model Number (REF): 781347 | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee rep... | One confirmed incident has been received that EFSRN4PR, lot number MP1982170, Size 4 Evolution MP... | Class II | MicroPort Orthopedics Inc. |
| May 3, 2024 | ADVANTA VXT, 8X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | ADVANTA VXT, 5-8X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | ADVANTA VXT, 7X80, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | ADVANTA VXT, 8X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
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.