Browse Device Recalls
4,602 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 4,602 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 4,602 FDA device recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 16, 2022 | Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System | Transcranial Doppler/ultrasound system tablet has a faulty hard drive, which will cause the syste... | Class II | NovaSignal Corp. |
| Dec 16, 2022 | NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of Nova... | Transcranial Doppler/ultrasound system tablet has a faulty hard drive, which will cause the syste... | Class II | NovaSignal Corp. |
| Dec 12, 2022 | BD Pyxis MedBank System - Product Label/labeling pending | Due to customer complaints related to the MedBank software which may indicate that a different me... | Class II | CareFusion 303, Inc. |
| Dec 7, 2022 | Single-Use Packs, REF: OPO80 | Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specific... | Class II | Johnson & Johnson Surgical Vision, Inc. |
| Dec 7, 2022 | Veritas Advanced Infusion Packs, REF: VRT-AI | Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specific... | Class II | Johnson & Johnson Surgical Vision, Inc. |
| Dec 7, 2022 | FUSION Dual Pump Packs, REF: OPO73 | Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specific... | Class II | Johnson & Johnson Surgical Vision, Inc. |
| Dec 5, 2022 | Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 ... | 3D orthodontic planning software has a defect that leads to an issue where incorrect number of al... | Class II | Align Technology Inc |
| Nov 28, 2022 | Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Tes... | Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emer... | Class I | Universal Meditech Inc. |
| Nov 21, 2022 | Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the ... | An app, part of a continuous glucose monitoring system, for use with smartphone devices may autom... | Class II | Medtronic MiniMed |
| Nov 18, 2022 | The Natus Cranial Access Kit is designed to be a complete, single use and dis... | Due to Cranial Access Kits containing recalled sterile surgical drapes. The sterile surgical dra... | Class II | Natus Medical Incorporated |
| Nov 10, 2022 | X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System ... | Potential that insert will be unable to disengage from the vertebral body replacement device/implant | Class II | NuVasive Inc |
| Nov 8, 2022 | InPen Diabetes Management App, part of the InPen System, REF: MMT-105ELBLNA, ... | Diabetes management app may crash immediately upon opening, while using the app and/or while app ... | Class II | Companion Medical, Inc. |
| Nov 1, 2022 | NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine dur... | During accelerated shelf-life extension studies it was noted that the final packaging was experie... | Class II | NuVasive Specialized Orthopedics, Inc. |
| Oct 21, 2022 | Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, ... | Sinus Implant product label displays incorrect product information including: "Straight Delivery ... | Class II | Intersect ENT, Inc. |
| Oct 14, 2022 | GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Sin... | Procedure Instruments with erroneous unit carton labels. | Class II | Sonendo Inc |
| Oct 14, 2022 | GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02 | Procedure Instruments with erroneous unit carton labels. | Class II | Sonendo Inc |
| Oct 12, 2022 | Superion¿ Indirect Decompression System (IDS) Model Numbers and Size: 101... | Due to Indirect Decompression System devices exhibiting a potential for weld breakage at the spin... | Class II | Boston Scientific Neuromodulation Corporation |
| Oct 7, 2022 | INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 48... | Potential staple deployment failure and device fragment generation | Class II | Intuitive Surgical, Inc. |
| Oct 6, 2022 | Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP | Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters... | Class II | Edwards Lifesciences, LLC |
| Oct 6, 2022 | Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 12... | Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters... | Class II | Edwards Lifesciences, LLC |
| Oct 3, 2022 | BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of ... | Due to partial label detachment on tubes. This can cause tubes to become stuck together in the po... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Oct 3, 2022 | BD Trucount Tubes (Cat. No. 663028), used for determining absolute counts of ... | Due to partial label detachment on tubes. This can cause tubes to become stuck together in the po... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Oct 3, 2022 | MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280 | Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate. | Class II | Beckman Coulter, Inc. |
| Oct 3, 2022 | BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), ... | Due to partial label detachment on tubes. This can cause tubes to become stuck together in the po... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Sep 29, 2022 | Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI... | After completion, ultrasound system's Stress Echo may not terminate if user does not manually ter... | Class II | Canon Medical System, USA, INC. |
| Sep 28, 2022 | Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Informa... | Ambulatory ECG monitoring system labeling update: 1) Clinically actionable arrhythmia notificatio... | Class II | iRhythm Technologies, Inc. |
| Sep 22, 2022 | AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100... | Due to increase in Li-Ion Battery failures | Class II | ZOLL Circulation, Inc. |
| Sep 21, 2022 | WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneury... | Detachment controller, of an aneurysm embolization system, has an out of specification tunnel ope... | Class II | MICROVENTION INC. |
| Sep 20, 2022 | Insulin Pump/Model: MiniMed 630G/ MMT-1715, MMT-1755, MMT-1754; MiniMed 67... | Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems... | Class II | Medtronic MiniMed |
| Sep 20, 2022 | Insulin Pump/Model: MiniMed 620G/ MMT-1750 MiniMed 640G/ MMT-1711, MMT-1712... | Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems... | Class II | Medtronic MiniMed |
| Sep 20, 2022 | da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devic... | Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instr... | Class II | Intuitive Surgical, Inc. |
| Sep 14, 2022 | Disc Preparation instruments contained in the following products: CI-11050-0... | Due to manufacturing instruments which included additional features and adequate consideration wa... | Class II | Alphatec Spine, Inc. |
| Sep 8, 2022 | Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT, MitraClip G... | An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked... | Class II | Abbott Vascular |
| Sep 8, 2022 | Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR, MitraClip N... | An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked... | Class II | Abbott Vascular |
| Sep 8, 2022 | Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G... | An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked... | Class II | Abbott Vascular |
| Sep 7, 2022 | Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308... | Product pouch label does not match up with carton label | Class II | BALT USA, LLC |
| Sep 7, 2022 | THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S... | Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irr... | Class II | Johnson & Johnson Surgical Vision, Inc. |
| Sep 2, 2022 | Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002 | COVID test kit shelf life was periodically extended, as real-time stability test timepoints passe... | Class II | LUMINOSTICS, INC dba CLIP HEALTH |
| Sep 1, 2022 | Veritas Advanced Infusion Packs. Used in ophthalmic procedures. | As a result of returned product complaints for Veritas Phaco packs related to broken or cracked i... | Class II | Johnson & Johnson Surgical Vision, Inc. |
| Aug 29, 2022 | OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power... | Battery may dislodge from the Power Knee | Class II | Ossur Americas |
| Aug 1, 2022 | BD MaxGuard Extension Set, REF: ME1069 | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Aug 1, 2022 | BD MaxGuard Extension Set with 4-way stopcock, REF: M4058 | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Aug 1, 2022 | BD MaxGuard Extension Set with 2 Needleless Y-Site, REF: MX9059 | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Aug 1, 2022 | 6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 C... | Due to a manufacturing defect which results in a visible gap between the connector's top and bott... | Class II | ICU Medical, Inc. |
| Aug 1, 2022 | BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: ... | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Aug 1, 2022 | BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS106 | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Aug 1, 2022 | 8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Re... | Due to a manufacturing defect which results in a visible gap between the connector's top and bott... | Class II | ICU Medical, Inc. |
| Aug 1, 2022 | The product is a handheld ultraviolet-C germicidal wand and contains two, nar... | Excessive ultraviolet-C radiation | Class II | MERCHSOURCE LLC |
| Aug 1, 2022 | BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS141 | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Aug 1, 2022 | BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: ... | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
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.