ClearanceBrief
Insights

Latest recalls of Class III devices

The 100 newest FDA recalls of Class III (highest risk) device types, by product code, with the 510(k)s they name.

Device class is the FDA risk class of the product code (I lowest, III highest). It is not the recall's own severity class, which the openFDA recall file does not carry.

DateFirm and productCodeLinked 510(k)
Nov 4, 2026GE Medical Systems, LLC
Senographe Pristina 3D
Open, Classified
OTENone listed
Nov 3, 2026Cochlear Limited
Cochlear Nucleus Nexa cochlear implant with Contour Advance electrode REF P1979576 Model Number: CI1000 UDI-DI codes: 9321502069847 Cochlear Nucleus CI1000 Series implants are prescription only, sing
Open, Classified
MCMNone listed
Nov 2, 2026Edwards Lifesciences, LLC
Generic Name: Edwards Commander M Delivery System Generic Name: Edwards Commander M Delivery System Model/Catalog Number: 9880CM29A Software Version: Not applicable. Product Description: Prosthesis, m
Open, Classified
NPUNone listed
Oct 28, 2026Abiomed, Inc.
Impella Connect Optical AIC, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pump.
Open, Classified
OZDNone listed
Oct 28, 2026Abiomed, Inc.
Impella Optical Controller, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pump.
Open, Classified
OZDNone listed
Oct 28, 2026Abiomed, Inc.
Automated Impella Controller, Packaged. Primary user control interface for the Impella Catheter, catheter-based heart pump.
Open, Classified
OZDNone listed
Oct 27, 2026Medtronic, Inc.
CareLink SmartSync Device Manager App, Model M01A02, Pulse generator, permanent, implantable
Open, Classified
NVZNone listed
Oct 27, 2026Medtronic, Inc.
CareLink SmartSync, RF Head Patient Connector, Model 24967, Pulse generator, permanent, implantable
Open, Classified
NVZNone listed
Oct 27, 2026Medtronic, Inc.
CareLink SmartSync Programmer, Model 24970A, Pulse generator, permanent, implantable
Open, Classified
NVZNone listed
Oct 23, 2026Medtronic, Inc.
OmniaSecure Model 3930M, LEAD 3930M74 74 CM DF4 MR 3930M74 LEAD 3930M79 79 CM DF4 MR 3930M79 The Medtronic OmniaSecure" Model 3930M lead is a steroid eluting, integrated bipolar, nonretractable scr
Open, Classified
NVYNone listed
Oct 22, 2026Medtronic Neuromodulation
InterStim Percutaneous Extensions EXT 3560022 ISTM II PERC 3560022 EXT 3560030 ISTM MICRO PERC 3560030
Open, Classified
EZWNone listed
Oct 22, 2026Medtronic Neuromodulation
InterStim SureScan MRI Leads 978A1 & 978B1: LEAD 978A128 ISTM MICRO 28CM SSMRI TINED 978A128 LEAD 978A133 ISTM MICRO 33CM SSMRI TINED 978A133 LEAD 978A141 ISTM MICRO 41CM SSMRI TINED 978A141 L
Open, Classified
QONNone listed
Oct 16, 2026Axonics, Inc.
PNE Lead Implant Kit REF: 1701
Open, Classified
EZWNone listed
Oct 16, 2026Abbott
Amplatzer Amulet Left Atrial Appendage Occluder Model Numbers 1. 9-ACP2-007-016 2. 9-ACP2-007-018 3. 9-ACP2-007-020 4. 9-ACP2-007-022 5. 9-ACP2-010-025 6. 9-ACP2-010-028 7. 9-ACP2-010-031 8. 9-ACP2-0
Open, Classified
NGVNone listed
Oct 9, 2026Jenavalve Technology Inc.
JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L
Open, Classified
NPTNone listed
Oct 9, 2026Jenavalve Technology Inc.
JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-M
Open, Classified
NPTNone listed
Oct 9, 2026Jenavalve Technology Inc.
JenaValve Trilogy Delivery Catheter, Size 23MM REF: TRILOGY-DC-S
Open, Classified
NPTNone listed
Sep 28, 2026Micro Therapeutics, Inc.
Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code: 00763000448806 he Pipeline Flex Embolization Device with Shield Technology consists of a permanent implant combin
Open, Classified
OUTNone listed
Sep 25, 2026HeartSine Technologies Ltd
HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Min
Open, Classified
MKJNone listed
Sep 21, 2026Abiomed, Inc.
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Pack
Open, Classified
OZDNone listed
Sep 16, 2026Abiomed, Inc.
Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions and corresponding Product Codes. 1. Optical, AIC, Impella Connect, Packaged, AU; P
Open, Classified
OZDNone listed
Sep 16, 2026Abiomed, Inc.
Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 2. Impella Optical Controller,
Open, Classified
OZDNone listed
Sep 16, 2026Abiomed, Inc.
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged
Open, Classified
OZDNone listed
Sep 16, 2026Howmedica Osteonics Corp.
OMNIFIT SERIES I ACET. INSERT 10 22mm ID Catalog No. 2001-2246 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Open, Classified
JDLK850352
K900438
Sep 4, 2026HeartSine Technologies Ltd
HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Min CPR UDI-DI code: 0506016712207 350P US Device, US English
Open, Classified
MKJNone listed
Aug 31, 2026Johnson & Johnson Surgical Vision, Inc.
HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 10300016 (US/CAN) HEALON EndoCoat PRO, REF: 10301012 (EU); HEALON DUET PRO II, REF: 10301016 (EU)
Open, Classified
LZPNone listed
Aug 18, 2026Medtronic MiniMed, Inc.
MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
Open, Classified
OZPNone listed
Aug 14, 2026Foundation Medicine, Inc.
Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.
Open, Classified
PQPNone listed
Aug 6, 2026Contego Medical, Inc
Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0630-140-2, NG-0640-140-2, NG-0730-140-2, NG-0740-140-2, NG-NV-
Open, Classified
NIMNone listed
Aug 5, 2026Boston Scientific Neuromodulation Corporation
INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, Material: M365SC2317700. part of the Boston Scientific Spinal Cord Stimulator (
Open, Classified
LGWNone listed
Jul 22, 2026Micro Therapeutics, Inc.
Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20. Intracranial aneurysm flow diverter
Open, Classified
OUTNone listed
Jul 22, 2026Micro Therapeutics, Inc.
Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12. Intracranial aneurysm flow diverter
Open, Classified
OUTNone listed
Jul 17, 2026Boston Scientific Corporation
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Open, Classified
QZINone listed
Jul 17, 2026Boston Scientific Corporation
FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter
Open, Classified
QZINone listed
Jul 17, 2026Boston Scientific Corporation
FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter
Open, Classified
QZINone listed
Jul 17, 2026Boston Scientific Corporation
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Open, Classified
QZINone listed
Jul 2, 2026W L Gore & Associates, Inc.
GORE TAG Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes Puerto Rico) and Canada: TSB080806A, TSB081006A, TSB081206A, TSB081506A, TSB081706A, T
Open, Classified
MIHNone listed
Jun 25, 2026Boston Scientific Corporation
Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
Completed
LKKNone listed
Jun 22, 2026TMJ Solutions Inc
TMJ Bilateral Implants, REF: CHG020
Open, Classified
LZDNone listed
Jun 18, 2026Inspire Medical Systems Inc.
Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product Description: The Inspire Stimulation Lead (Model 4063) is designed to deliver stimul
Open, Classified
MNQNone listed
Jun 18, 2026Thoratec LLC
Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog Number: 106128 Software Version: N/A Product Description: The HeartMate 11 Volt Lithium Ion Standalone Backup Batter
Open, Classified
DSQNone listed
Jun 18, 2026Thoratec LLC
Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description: The HeartMate 3" System Controller acts as the central powe
Open, Classified
DSQNone listed
Jun 18, 2026Thoratec LLC
Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist S
Open, Classified
DSQNone listed
Jun 18, 2026Staar Surgical AG
Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL Calculation Software is designed as an aide in the calculation of the size and diopter po
Open, Classified
MTANone listed
Jun 18, 2026Inspire Medical Systems Inc.
Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340 Software Version: N/A Product Description: The Inspire Respiratory Sensing Lead (Mod
Open, Classified
MNQNone listed
Jun 18, 2026Abiomed, Inc.
Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
Open, Classified
OZDNone listed
Jun 12, 2026Abiomed, Inc.
Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-00
Open, Classified
OZDNone listed
Jun 11, 2026Abbott Medical
Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
Open, Classified
PNJNone listed
Jun 11, 2026Boston Scientific Neuromodulation Corporation
Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Open, Classified
LGWNone listed
Jun 10, 2026DT MedTech, LLC
Hintermann Series Talar Implant, Left, Size 2 REF 302112
Open, Classified
NTGNone listed
Jun 5, 2026INSPIREMD Inc
CGuard Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040
Open, Classified
NIMNone listed
Jun 5, 2026INSPIREMD Inc
CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030
Open, Classified
NIMNone listed
Jun 5, 2026INSPIREMD Inc
Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940
Open, Classified
NIMNone listed
Jun 5, 2026INSPIREMD Inc
CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930
Open, Classified
NIMNone listed
Jun 5, 2026INSPIREMD Inc
Brand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840
Open, Classified
NIMNone listed
Jun 5, 2026INSPIREMD Inc
Brand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830
Open, Classified
NIMNone listed
Jun 5, 2026BERLIN HEART GMBH
EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
Open, Classified
DSQNone listed
Jun 1, 2026Advanced Bionics, LLC
Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number: CI-1601-04 Software Version: N/A Product Description: The HiResolution Bionic Ear Sy
Open, Classified
MCMNone listed
May 28, 2026Medtronic Neuromodulation
Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor
Open, Classified
MHYNone listed
May 28, 2026Medtronic Neuromodulation
Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor
Open, Classified
MHYNone listed
May 28, 2026Abiomed, Inc.
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packa
Open, Classified
OZDNone listed
May 22, 2026Abiomed, Inc.
Automated Impella Controller (AIC); Product Code: 0042-0000-US;
Open, Classified
OZDNone listed
May 22, 2026Bolton Medical Inc.
RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-32U 28-N4-32-209-28U 28-N4-32-209-32U 28-N4-32-259-32U 28-N4-34-109-34U 28-N4-34-
Open, Classified
MIHNone listed
May 14, 2026MICROVENTION INC.
LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 mm x 18 mm, 214518-CAS/4.5 mm x 18 mm x 14 mm, 213517-CAS/3.5 mm x 17 mm x 13 mm
Open, Classified
QCANone listed
May 14, 2026Medtronic Neuromodulation
Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A CLINICIAN TABLET US, Model Number CT900A; 2. PROG CT900B C
Open, Classified
LKKNone listed
May 13, 2026Edwards Lifesciences, LLC
Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Open, Classified
NPWNone listed
May 12, 2026Hologic, Inc
3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3DM-SYS-INTL3D-MOB, 3DM-SYS-INTL3D-NS, 3DM-SYS-STD, 3DM-SYS-STD-MOB, 3DM-SYS-STD-N
Open, Classified
OTENone listed
May 8, 2026On-X Life Technologies, Inc.
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Open, Classified
LWQNone listed
May 4, 2026Physio-Control, Inc.
LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935, 99577-001964, 99577-001955, 99577-001956, 99577-001588, 9
Open, Classified
MKJNone listed
May 1, 2026Centinel Spine, Inc.
Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.
Open, Classified
MJONone listed
May 1, 2026Centinel Spine, Inc.
Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
Open, Classified
MJONone listed
Apr 27, 2026Advanced Bionics, LLC
Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110; CI-5501-120; CI-5501-130; CI-5501-140; CI-5501-150; CI-5501-190; CI-5501-240; CI-5501-
Open, Classified
MCMNone listed
Apr 24, 2026Medtronic, Inc.
Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.
Open, Classified
OADNone listed
Apr 24, 2026Boston Scientific Corporation
Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VALITUDE CRT-P EL MRI, Model Number U128; 3. VISIONIST CRT-P EL, Model Number U225;
Open, Classified
NKENone listed
Apr 24, 2026Boston Scientific Corporation
Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as: 1. ESSENTIO SR SL, Model Number L100; 2. ESSENTIO DR SL Pacemaker, Model Nu
Open, Classified
LWPNone listed
Apr 23, 2026Foundation Medicine, Inc.
Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory Equipment IDs 01342, 01591, 01989, 01990
Open, Classified
PQPNone listed
Apr 22, 2026Foundation Medicine, Inc.
Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
Open, Classified
PQPNone listed
Apr 21, 2026Davol, Inc.
Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.
Open, Classified
LMFNone listed
Apr 16, 2026THERAKOS DEVELOPMENT LIMITED
Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Applicable Product Description: THERAKOS Photopheresis or extracorpore
Open, Classified
LNRNone listed
Apr 2, 2026Medtronic MiniMed, Inc.
MiniMed 530G Insulin Pump (MMT-551, MMT-751)
Open, Classified
OZONone listed
Apr 2, 2026Medtronic MiniMed, Inc.
Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
Open, Classified
OYCNone listed
Apr 2, 2026Medtronic MiniMed, Inc.
Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)
Open, Classified
OYCNone listed
Apr 2, 2026Medtronic MiniMed, Inc.
MiniMed 620G Insulin Pump (MMT-1750)
Open, Classified
OYCNone listed
Apr 2, 2026Medtronic MiniMed, Inc.
MiniMed 740G Insulin Pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862)
Open, Classified
OYCNone listed
Apr 2, 2026Medtronic MiniMed, Inc.
MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)
Open, Classified
OYCNone listed
Apr 2, 2026Medtronic MiniMed, Inc.
MiniMed 640G Insulin Pump (MMT-1711, MMT-1712, MMT-1751, MMT-1752)
Open, Classified
OYCNone listed
Apr 2, 2026Medtronic MiniMed, Inc.
MiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
Open, Classified
OZPNone listed
Apr 2, 2026Medtronic MiniMed, Inc.
MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
Open, Classified
OZONone listed
Apr 2, 2026Medtronic MiniMed, Inc.
MiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)
Open, Classified
OZPNone listed
Mar 31, 2026Abiomed, Inc.
Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes. 1. Purge Cassette, 5 Pack; Product Code:
Open, Classified
OZDNone listed
Mar 27, 2026ReCor Medical Inc.
Brand Name: Paradise Ultrasound Renal Denervation System Product Name: Paradise Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common name: Ablation catheter renal denervation
Open, Classified
QYINone listed
Mar 27, 2026ReCor Medical Inc.
Brand Name: Paradise Ultrasound Renal Denervation System Product Name: Paradise Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common name: Ablation catheter renal denervation
Open, Classified
QYINone listed
Mar 27, 2026Abiomed, Inc.
Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU;
Open, Classified
OZDNone listed
Mar 24, 2026AMO Puerto Rico Manufacturing, Inc.
Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Model/Catalog Number: DIB00 Software Version: N/A Produc
Open, Classified
HQLNone listed
Mar 19, 2026Hologic, Inc.
Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
Open, Classified
OYBNone listed
Mar 19, 2026LeMaitre Vascular, Inc.
Artegraft Vascular Graft; REF#: AG740;
Open, Classified
LXANone listed
Mar 10, 2026Physio-Control, Inc.
PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Number: 11101-000017 UDI-DI code: 00721902682483 Infant/Child Re
Open, Classified
MKJNone listed
Mar 5, 2026Advanced Bionics, LLC
Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
Open, Classified
MCMNone listed
Mar 2, 2026Staar Surgical AG
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
Open, Classified
QCBNone listed
Feb 27, 2026Abiomed, Inc.
Impella RP. Product Code: 0046-0011.
Open, Classified
PYXNone listed

More: Medical device recalls by FDA device class · Recalls within a year of 510(k) clearance · Most recalled device types by review panel · Top 510(k) applicants in the last 12 months · Latest recalls of Class II devices · Latest recalls of Class I devices · Companies with the most medical device recalls