Browse Device Recalls
2,260 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,260 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 2,260 FDA device recalls in 2021.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 17, 2021 | ARIES HSV 1&2 Assay, Catalog/REF# 50-10017 | Impacted lot may leak inside the ARIES instrument. Testing confirmed a leak rate of 0.9%. Leaking... | Class II | Luminex Corporation |
| Nov 17, 2021 | Malosa Core Suface Treatment Pack -Medical Corneal Kit intended to be used to... | Kit packaging may have small holes compromising product sterility | Class II | Beaver Visitec International, Inc. |
| Nov 17, 2021 | Malosa Core Phaco Pack 2- Medical Refractive Kit intended to be used to aid i... | Kit packaging may have small holes compromising product sterility | Class II | Beaver Visitec International, Inc. |
| Nov 17, 2021 | Malosa Core Phaco Pack 1-Medical Cataract Kit intended to be used to aid in c... | Kit packaging may have small holes compromising product sterility | Class II | Beaver Visitec International, Inc. |
| Nov 17, 2021 | Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid i... | Kit packaging may have small holes compromising product sterility | Class II | Beaver Visitec International, Inc. |
| Nov 17, 2021 | Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Refractive Kit intended to... | Kit packaging may have small holes compromising product sterility | Class II | Beaver Visitec International, Inc. |
| Nov 17, 2021 | Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in... | Kit packaging may have small holes compromising product sterility | Class II | Beaver Visitec International, Inc. |
| Nov 17, 2021 | Senior Living Arial Emergency and Nurse Call Systems | Systems are not alarming due to increased memory consumption. | Class II | Stanley Security Solutions Inc |
| Nov 17, 2021 | DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile | The firm identified a nonconformance in Lot 04882 involving the endcap being manufactured to a lo... | Class II | Medshape, INC. |
| Nov 16, 2021 | Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and... | Increase in premature device failures | Class II | Ohio Medical Corporation |
| Nov 16, 2021 | cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material... | Roche has identified a small number of cobas Liat analyzer units that have consistently high nois... | Class II | Roche Molecular Systems, Inc. |
| Nov 16, 2021 | Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM | As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Introducer devices was m... | Class II | Abbott |
| Nov 15, 2021 | Cardiosave Hybrid IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-31, 0... | Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the devic... | Class I | Datascope Corp. |
| Nov 15, 2021 | Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0... | Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the devic... | Class I | Datascope Corp. |
| Nov 12, 2021 | Invacare AVIVA Storm RX with LiNX Gyro Power Wheelchair (with LiNX Gyro Modul... | Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more... | Class II | Invacare Corporation |
| Nov 12, 2021 | ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B | Due to a calculation error in the measurement when using 2D trace (manual trace) tool. The trace... | Class II | Siemens Medical Solutions USA, Inc. |
| Nov 12, 2021 | Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model... | Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more... | Class II | Invacare Corporation |
| Nov 12, 2021 | BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisi... | Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly h... | Class II | Philips North America Llc |
| Nov 12, 2021 | Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38... | Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label statin... | Class II | Cook Inc. |
| Nov 12, 2021 | Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging a... | Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly h... | Class II | Philips North America Llc |
| Nov 12, 2021 | TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS0... | Suction Instruments were incorrectly calibrated so they may not meet the system accuracy specific... | Class II | Acclarent, Inc. |
| Nov 12, 2021 | Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-... | Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label statin... | Class II | Cook Inc. |
| Nov 12, 2021 | Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusabl... | Intermittent risk of electric shock to users if an affected charger is used in conjunction with a... | Class II | Covidien Llc |
| Nov 12, 2021 | Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 wi... | (1)Start-up problem: Intermittently at start-up of the system, the communication of the control u... | Class II | Philips North America Llc |
| Nov 12, 2021 | Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Mod... | Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more... | Class II | Invacare Corporation |
| Nov 12, 2021 | BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisi... | Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly h... | Class II | Philips North America Llc |
| Nov 11, 2021 | O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Ins... | Due to product label/labeling being altered from it's approved state. | Class II | Orchestrate Orthodontic Technologies, Inc. |
| Nov 11, 2021 | Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or ... | Cranial biopsy procedure software can enter a state where the biopsy depth gauge is no longer syn... | Class I | Medtronic Navigation, Inc. |
| Nov 10, 2021 | PIVO Blood Collection Device 20G, REF: 202-0005 | Incomplete sealing of blood collection device unit packages may produce a breach in the sterile b... | Class II | Velano Vascular |
| Nov 10, 2021 | iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery S... | The dosage information on the pouch is incorrect; the primary carton label is correct. | Class III | Tapemark Company |
| Nov 10, 2021 | SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825 | Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B... | Class II | Beckman Coulter Inc. |
| Nov 9, 2021 | RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in... | There is an error in the new version of the package insert. The Reading Table lists the incorrec... | Class II | Biomerieux Inc |
| Nov 9, 2021 | Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJ... | Instructions for use were updated to include additional information to facilitate the selection a... | Class II | Ossur Americas |
| Nov 9, 2021 | Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealt... | A tracker that holds and guides neurosurgical surgical instruments may be subject to separation/w... | Class II | Medtronic Navigation, Inc. |
| Nov 9, 2021 | Amplatzer Steerable Delivery Sheath | Instructions for use were updated. | Class II | Abbott |
| Nov 9, 2021 | Torosa Saline-Filled Testicular Prosthesis (Size Small) | Product is mislabeled for size. | Class II | Coloplast Manufacturing US, LLC |
| Nov 8, 2021 | Medical Device Identification Cards associated with Astra XT DR Implantable p... | The back of some Medical Device Identification Cards provided to patients were printed with an er... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Nov 8, 2021 | Medical Device Identification Cards associated with Sprint Quattro Lead, Prod... | The back of some Medical Device Identification Cards provided to patients were printed with an er... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Nov 8, 2021 | Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbe... | Manufacturing instructions did not include the directions to not retest the pneumatic kit compone... | Class II | Boston Scientific Corporation |
| Nov 8, 2021 | QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 69... | The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-... | Class II | Qiagen Sciences LLC |
| Nov 5, 2021 | DigniCap Delta Scalp Cooling System, Product Number: 900-1001, Labeling: The... | Instructions for Use (IFUs) updated to include use of a headband is now recommended for all patie... | Class II | Dignitana, Inc. |
| Nov 4, 2021 | FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test | Devices are determined to be inconsistent with the firm's Emergency Use Authorization (EUA). Thi... | Class II | Migo Trading LLC |
| Nov 4, 2021 | GE Vscan Extend, being sold as "Vscan Extend Dual DICOM" | The firm identified that the Vscan Extend device will not power on because of depleted battery, d... | Class II | GE Healthcare, LLC |
| Nov 4, 2021 | INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS | The package contents and package labeling do not match. | Class II | Wright Medical Technology Inc |
| Nov 4, 2021 | Puritan Bennett 980 Series Ventilator, 980X1PLDIPC | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... | Class I | Covidien Llc |
| Nov 4, 2021 | Puritan Bennett 980 Series Ventilator, 980X3JADIJJ | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... | Class I | Covidien Llc |
| Nov 4, 2021 | Puritan Bennett 980 Series Ventilator, 980U3ESDIUU | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... | Class I | Covidien Llc |
| Nov 4, 2021 | Puritan Bennett 980 Series Ventilator,980X1ENAIQC | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... | Class I | Covidien Llc |
| Nov 4, 2021 | Puritan Bennett 980 Series Ventilator, 980X1JADIJJ | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... | Class I | Covidien Llc |
| Nov 4, 2021 | regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn... | The kit contains a non-sterile needle. | Class II | ROi CPS LLC |
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.