Browse Device Recalls
2,276 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,276 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 2,276 FDA device recalls in 2022.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 3, 2022 | EXALT Model D Single- Use Duodenoscope (Box 1) UPN: M00542420 Intended ... | Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known... | Class II | Boston Scientific Corporation |
| Mar 3, 2022 | iCast Covered Stent System Product Code/Part Number: 85400 85401 85402 ... | Firm has observed increased rate of customer complaints related to separation of the balloon or c... | Class I | Atrium Medical Corporation |
| Mar 3, 2022 | Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Numb... | Firm has observed increased rate of customer complaints related to separation of the balloon or c... | Class I | Atrium Medical Corporation |
| Mar 3, 2022 | DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument ... | Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection c... | Class II | Intuitive Surgical, Inc. |
| Mar 3, 2022 | EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421 Intended ... | Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known... | Class II | Boston Scientific Corporation |
| Mar 3, 2022 | Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in ... | Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret p... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 3, 2022 | Pneumonia (33 Targets) Control Panel, unassayed quality control material, con... | Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of... | Class II | Microbiologics Inc |
| Mar 3, 2022 | DeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic (ch... | A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods... | Class II | DeRoyal Industries Inc |
| Mar 3, 2022 | VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vin... | Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection c... | Class II | Intuitive Surgical, Inc. |
| Mar 3, 2022 | ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use i... | Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret p... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 3, 2022 | DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine glu... | A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods... | Class II | DeRoyal Industries Inc |
| Mar 3, 2022 | ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the ... | Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret p... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 2, 2022 | First Aid Kits containing acetaminophen under brand names Equate (Walmart), M... | Kits contained recalled acetaminophen. | Class II | ASO LLC |
| Mar 2, 2022 | Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonar... | There is potential for the capsule bond to break during the procedure. | Class I | Medtronic Inc |
| Mar 1, 2022 | Access-9 Large Bore Hemostasis Valves, Catalog Code: 580775001, IN8112/C, K05... | A design change made to a hemostasis valve to improve manufacturability caused an internal gap be... | Class II | Merit Medical Systems, Inc. |
| Mar 1, 2022 | AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, ... | A design change made to a hemostasis valve to improve manufacturability caused an internal gap be... | Class II | Merit Medical Systems, Inc. |
| Mar 1, 2022 | FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10 | The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter M... | Class II | Edwards Lifesciences, LLC |
| Mar 1, 2022 | FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monito... | The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter M... | Class II | Edwards Lifesciences, LLC |
| Feb 28, 2022 | NanoSight LM10 fitted with LM14 module. A laboratory instrument for determin... | Product found to not comply to Class 1 Laser safety requirement. | Class II | MALVERN PANALYTICAL LTD |
| Feb 28, 2022 | Regard IV Start Kit for preparing and/or dressing a peripheral vein intraveno... | A kit component, the PDI Prevantics Swab, was recalled. | Class II | Resource Optimization & Innovation LLC |
| Feb 28, 2022 | Integra Universal Flexible Arm part number REF 1362275 | Excess force used to tighten the Universal Flexible Arm can cause the internal cable to break at ... | Class II | Integra LifeSciences Corp. |
| Feb 28, 2022 | MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the fo... | There is a software anomaly with the InterStim X Clinician software application with results in t... | Class II | Medtronic Neuromodulation |
| Feb 28, 2022 | Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, ... | Ventilator units have an issue impacting an internal electrical circuit within the ventilators, t... | Class I | Respironics California, LLC |
| Feb 28, 2022 | NanoSight LM10 fitted with LM12 module. A laboratory instrument for determin... | Product found to not comply to Class 1 Laser safety requirement. | Class II | MALVERN PANALYTICAL LTD |
| Feb 28, 2022 | Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137... | Ventilator units have an issue impacting an internal electrical circuit within the ventilators, t... | Class I | Respironics California, LLC |
| Feb 28, 2022 | Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (8500... | Ventilator units have an issue impacting an internal electrical circuit within the ventilators, t... | Class I | Respironics California, LLC |
| Feb 25, 2022 | syngo Application software VE20 (Material Number 10848815) installed on the ... | After CT image data from Toshiba is loaded, image mirroring can occur along the horizontal and ve... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 25, 2022 | Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H9386... | Product is mislabeled as self-righting Luer slip tip caps, yellow. | Class II | Baxter Healthcare Corporation |
| Feb 25, 2022 | Lum Lam Custom Pack - Anesthesia Kit | The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit. | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Feb 25, 2022 | therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the... | False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status result... | Class II | Qiagen Sciences LLC |
| Feb 25, 2022 | Artis pheno- in combination with a Siemens Healthineers table or Trumpf/MAQUE... | Five potential software issues affecting Artis pheno and Artis icono systems in combination with ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 25, 2022 | ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Mon... | The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs. | Class II | Brainlab AG |
| Feb 25, 2022 | DigitalDiagnost C50 1.1 | Following a system restart where the Table Height 2 (TH2) is the default setting and then switche... | Class II | Philips North America Llc |
| Feb 25, 2022 | Total Knee Pack - Surgical Kit | The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit. | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Feb 25, 2022 | Artis icono biplane- in combination with a Siemens Healthineers table or Tru... | Five potential software issues affecting Artis pheno and Artis icono systems in combination with ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 25, 2022 | Anterior Hip Pack - Surgical Kit | The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit. | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Feb 25, 2022 | MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C448... | Devices distributed lacked regulatory clearance. | Class II | Baxter Healthcare Corporation |
| Feb 25, 2022 | therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD) | False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status result... | Class II | Qiagen Sciences LLC |
| Feb 25, 2022 | Surgicare Neuro Pack - Neurological Kit | The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit. | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Feb 25, 2022 | Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 | Kits were labeled with incorrect expiration dates. | Class II | CELLTRION USA INC |
| Feb 25, 2022 | Artis icono floor in combination with a Siemens Healthineers table or Trumpf... | Five potential software issues affecting Artis pheno and Artis icono systems in combination with ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 25, 2022 | Mycoplasma genitalium Control Panel (Inactivated Pellet) | Distributed product did not undergo proper release testing. | Class II | Microbiologics Inc |
| Feb 25, 2022 | Coryell Memorial Hosp Total, Joint Pack - Surgical Kit | The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit. | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Feb 24, 2022 | Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Steri... | Surgical knives may contain incorrect description printed on handles. Specifically, some surgical... | Class II | International Science & Technology, LP, DBA Dia... |
| Feb 24, 2022 | Regard Custom Procedure Kits containing BD Luer Lok Access Devices | Recalled devices were packaged in convenience kits. | Class III | ROi CPS LLC |
| Feb 24, 2022 | SpaceOAR Vue System, UPN SV-1010 and SV-2101. Used to temporarily position t... | Users need to be aware that embolism is a possible adverse event associated with hydrogel misplac... | Class II | Boston Scientific Corporation |
| Feb 24, 2022 | SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to tempora... | Users need to be aware that embolism is a possible adverse event associated with hydrogel misplac... | Class II | Boston Scientific Corporation |
| Feb 23, 2022 | (a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degre... | The finished device package did not contain the IFU. | Class II | Carefusion 2200 Inc |
| Feb 23, 2022 | Artis zeego, Model Number 10280959 | If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 23, 2022 | Artis zee floor, Model Number 10094135 | If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... | Class II | Siemens Medical Solutions USA, Inc |
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.