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 |
|---|---|---|---|---|
| Aug 2, 2021 | BD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG ACCESS DEVICE CHECK V... | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES, REF: 20019E | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing Smart... | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD SE Burette Set 20 Drops 2 Injection Ports Vented/NonVented, REF: 72103E-0006 | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD Gravity IV Set 3-port Closed Manifold Back Check Valve 3 Needle-Free Y-sit... | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD Gravity Burette Set 60 DROP 1.2 MF 2 SmartSite VALVES BALL VALVE DRIP CHAM... | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Jul 29, 2021 | HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144 | One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook mode... | Class II | Mizuho OSI |
| Jul 28, 2021 | Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockya... | Missing splash guard which may expose users to hazardous materials. . | Class II | Beckman Coulter Inc. |
| Jul 22, 2021 | BD" Mouse IgG2a Isotype Control APC X39 ASR | Complaints have been received for performance issues related to high background and staining. th... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Jul 21, 2021 | DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use"... | There is a potential that sample carriers (w or w/o samples) within automated sampling system ma... | Class II | Beckman Coulter Inc. |
| Jul 20, 2021 | Nihon Kohden NKV-550 Ventilator, REF: NKV-550-U, CE 0344, UDI: (01) 008436851... | Potential defective gas inlet pressure regulator within ventilator which could result in gas rel... | Class II | NIHON KOHDEN ORANGEMED, INC |
| Jul 15, 2021 | Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15,... | Mouse Monoclonal Antibody labelled with an incorrect expiry date of 31 Dec 2023. The correct expi... | Class III | Cell Marque Corporation |
| Jul 15, 2021 | Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017... | There is a potential that the data management system may add additional cells to the patient requ... | Class II | Beckman Coulter Inc. |
| Jul 14, 2021 | FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA | Angioplasty system has a manufacturing issue that has the potential to result in difficulty defla... | Class II | Ostial Corporation |
| Jul 13, 2021 | Pipeline Flex Embolization Device | Due to potential push wire fractures in the delivery system during use. The issue presents as a ... | Class I | Micro Therapeutics Inc, |
| Jul 13, 2021 | EV3 Pipeline Flex Embolization Device with Flex Shield Technology | Due to potential push wire fractures in the delivery system during use. The issue presents as a ... | Class I | Micro Therapeutics Inc, |
| Jul 9, 2021 | EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombo... | EVEXIA LUXE DVT PREVENTION DEVICE is marketed without FDA clearance | Class II | Ortho8, Inc. |
| Jul 9, 2021 | Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Num... | There is a potential for internal leaks within catheters. | Class II | Edwards Lifesciences, LLC |
| Jul 9, 2021 | AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABE... | Scope tube tip may detach from the telescoping tube, which is attached to a single-use handpiece,... | Class II | PROCEPT BIOROBOTICS CORPORATION |
| Jul 9, 2021 | Edwards PediaSat Oximetry Catheter Set, REF: XT358KTP, Exterior Diameter 5.5F... | There is a potential for internal leaks within catheters. | Class II | Edwards Lifesciences, LLC |
| Jul 9, 2021 | Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F... | There is a potential for internal leaks within catheters. | Class II | Edwards Lifesciences, LLC |
| Jul 9, 2021 | Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5... | There is a potential for internal leaks within catheters. | Class II | Edwards Lifesciences, LLC |
| Jul 9, 2021 | Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F ... | There is a potential for internal leaks within catheters. | Class II | Edwards Lifesciences, LLC |
| Jul 9, 2021 | Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F... | There is a potential for internal leaks within catheters. | Class II | Edwards Lifesciences, LLC |
| Jul 9, 2021 | CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thromb... | CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance | Class II | Ortho8, Inc. |
| Jul 8, 2021 | Zippie Voyage, early intervention stroller - Product Usage: is manually opera... | The seating system unexpectedly detached, which resulted in the seating system falling to the gro... | Class II | Sunrise Medical (US) LLC |
| Jul 8, 2021 | Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRU... | Due to failure to acquire pre-market clearance for its high resolution tomographic/biomicroscope ... | Class II | Carl Zeiss Meditec, Inc. |
| Jul 8, 2021 | Zippie Voyage, early intervention stroller - Product Usage: is manually opera... | The seating system unexpectedly detached, which resulted in the seating system falling to the gro... | Class II | Sunrise Medical (US) LLC |
| Jul 5, 2021 | CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW releas... | An incorrect error messaging system that could potentially lead to: 1) Reporting a thermal event ... | Class II | Zeltiq Aesthetics, Inc |
| Jul 2, 2021 | The Hero Model 100 (H-100) is a system consisting of a smart pill dispenser a... | Due to dispenser prompting for a missed dose that had already been dispensed | Class II | Hero Health |
| Jul 1, 2021 | Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.... | SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect... | Class II | Beckman Coulter Inc. |
| Jul 1, 2021 | ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713; | SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect... | Class II | Beckman Coulter Inc. |
| Jul 1, 2021 | ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTIO... | SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect... | Class II | Beckman Coulter Inc. |
| Jul 1, 2021 | ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 ... | SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect... | Class II | Beckman Coulter Inc. |
| Jun 18, 2021 | Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. T... | It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 a... | Class I | Respironics California, LLC |
| Jun 18, 2021 | Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10.... | It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 a... | Class I | Respironics California, LLC |
| Jun 11, 2021 | CoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US; D... | Due to reports of actuator separation for various delivery catheter systems. Affected products w... | Class II | Medtronic Heart Valves Division |
| Jun 11, 2021 | CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-L; ENVEOR-N; | Due to reports of actuator separation for various delivery catheter systems. Affected products w... | Class II | Medtronic Heart Valves Division |
| Jun 11, 2021 | CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16; | Due to reports of actuator separation for various delivery catheter systems. Affected products w... | Class II | Medtronic Heart Valves Division |
| Jun 9, 2021 | MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product ... | A portion of a validation lot was inadvertently released to the US Market. The product did not m... | Class II | CAREFUSION |
| Jun 7, 2021 | Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Gra... | During product complaint investigation, it was determined that during stent graft deployment, the... | Class II | Medtronic Vascular, Inc. |
| Jun 7, 2021 | reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as ... | Due to a software issue, patients with a urine drug screen (UDS) received access to a contingency... | Class II | Pear Therapeutics, Inc. |
| Jun 7, 2021 | Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent G... | During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of th... | Class II | Medtronic Vascular, Inc. |
| Jun 7, 2021 | reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, a... | Due to a software issue, patients with a urine drug screen (UDS) received access to a contingency... | Class II | Pear Therapeutics, Inc. |
| Jun 3, 2021 | BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bu... | Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequ... | Class II | Axonics Modulation Technologies, Inc. |
| Jun 1, 2021 | OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross imm... | Due to insufficient column strength of the racks for all load conditions, racks associated with h... | Class II | Ossur Americas |
| May 27, 2021 | Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, R... | Product distributed for use as an In-vitro Diagnostics without FDA clearance | Class II | Cell Marque Corporation |
| May 27, 2021 | Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, I... | Product distributed for use as an In-vitro Diagnostics without FDA clearance | Class II | Cell Marque Corporation |
| May 26, 2021 | Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit, REF: PXVJ356, Pressure Mon... | There is a potential that the pressure tubing may detach from the blood sampling system | Class II | Edwards Lifesciences, LLC |
| May 26, 2021 | Edwards TruWave (30 cc)/VAMP Jr Kit, REF: VMP306PX, Pressure Monitoring Set, ... | There is a potential that the pressure tubing may detach from the blood sampling system | Class II | Edwards Lifesciences, 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.