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.
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 4, 2026 | GE Medical Systems, LLC Senographe Pristina 3D Open, Classified |
OTE | None listed |
| Nov 3, 2026 | Cochlear 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 |
MCM | None listed |
| Nov 2, 2026 | Edwards 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 |
NPU | None listed |
| Oct 28, 2026 | Abiomed, Inc. Impella Connect Optical AIC, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pump. Open, Classified |
OZD | None listed |
| Oct 28, 2026 | Abiomed, Inc. Impella Optical Controller, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pump. Open, Classified |
OZD | None listed |
| Oct 28, 2026 | Abiomed, Inc. Automated Impella Controller, Packaged. Primary user control interface for the Impella Catheter, catheter-based heart pump. Open, Classified |
OZD | None listed |
| Oct 27, 2026 | Medtronic, Inc. CareLink SmartSync Device Manager App, Model M01A02, Pulse generator, permanent, implantable Open, Classified |
NVZ | None listed |
| Oct 27, 2026 | Medtronic, Inc. CareLink SmartSync, RF Head Patient Connector, Model 24967, Pulse generator, permanent, implantable Open, Classified |
NVZ | None listed |
| Oct 27, 2026 | Medtronic, Inc. CareLink SmartSync Programmer, Model 24970A, Pulse generator, permanent, implantable Open, Classified |
NVZ | None listed |
| Oct 23, 2026 | Medtronic, 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 |
NVY | None listed |
| Oct 22, 2026 | Medtronic Neuromodulation InterStim Percutaneous Extensions
EXT 3560022 ISTM II PERC
3560022
EXT 3560030 ISTM MICRO PERC
3560030 Open, Classified |
EZW | None listed |
| Oct 22, 2026 | Medtronic 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 |
QON | None listed |
| Oct 16, 2026 | Axonics, Inc. PNE Lead Implant Kit
REF: 1701 Open, Classified |
EZW | None listed |
| Oct 16, 2026 | Abbott 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 |
NGV | None listed |
| Oct 9, 2026 | Jenavalve Technology Inc. JenaValve Trilogy Delivery Catheter, Size 27MM
REF: TRILOGY-DC-L Open, Classified |
NPT | None listed |
| Oct 9, 2026 | Jenavalve Technology Inc. JenaValve Trilogy Delivery Catheter, Size 25MM
REF: TRILOGY-DC-M Open, Classified |
NPT | None listed |
| Oct 9, 2026 | Jenavalve Technology Inc. JenaValve Trilogy Delivery Catheter, Size 23MM
REF: TRILOGY-DC-S Open, Classified |
NPT | None listed |
| Sep 28, 2026 | Micro 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 |
OUT | None listed |
| Sep 25, 2026 | HeartSine 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 |
MKJ | None listed |
| Sep 21, 2026 | Abiomed, 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 |
OZD | None listed |
| Sep 16, 2026 | Abiomed, 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 |
OZD | None listed |
| Sep 16, 2026 | Abiomed, 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 |
OZD | None listed |
| Sep 16, 2026 | Abiomed, 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 |
OZD | None listed |
| Sep 16, 2026 | Howmedica Osteonics Corp. OMNIFIT SERIES I ACET. INSERT 10 22mm ID
Catalog No. 2001-2246
Orthopaedic implant components manufactured from UHMWPE (polyethylene) Open, Classified |
JDL | K850352 K900438 |
| Sep 4, 2026 | HeartSine 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 |
MKJ | None listed |
| Aug 31, 2026 | Johnson & 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 |
LZP | None listed |
| Aug 18, 2026 | Medtronic MiniMed, Inc. MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782; Open, Classified |
OZP | None listed |
| Aug 14, 2026 | Foundation Medicine, Inc. Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx. Open, Classified |
PQP | None listed |
| Aug 6, 2026 | Contego 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 |
NIM | None listed |
| Aug 5, 2026 | Boston 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 |
LGW | None listed |
| Jul 22, 2026 | Micro 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 |
OUT | None listed |
| Jul 22, 2026 | Micro 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 |
OUT | None listed |
| Jul 17, 2026 | Boston Scientific Corporation FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter Open, Classified |
QZI | None listed |
| Jul 17, 2026 | Boston Scientific Corporation FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter Open, Classified |
QZI | None listed |
| Jul 17, 2026 | Boston Scientific Corporation FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter Open, Classified |
QZI | None listed |
| Jul 17, 2026 | Boston Scientific Corporation FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter Open, Classified |
QZI | None listed |
| Jul 2, 2026 | W 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 |
MIH | None listed |
| Jun 25, 2026 | Boston Scientific Corporation Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device Completed |
LKK | None listed |
| Jun 22, 2026 | TMJ Solutions Inc TMJ Bilateral Implants, REF: CHG020 Open, Classified |
LZD | None listed |
| Jun 18, 2026 | Inspire 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 |
MNQ | None listed |
| Jun 18, 2026 | Thoratec 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 |
DSQ | None listed |
| Jun 18, 2026 | Thoratec 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 |
DSQ | None listed |
| Jun 18, 2026 | Thoratec 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 |
DSQ | None listed |
| Jun 18, 2026 | Staar 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 |
MTA | None listed |
| Jun 18, 2026 | Inspire 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 |
MNQ | None listed |
| Jun 18, 2026 | Abiomed, Inc. Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP. Open, Classified |
OZD | None listed |
| Jun 12, 2026 | Abiomed, 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 |
OZD | None listed |
| Jun 11, 2026 | Abbott Medical Merlin" Patient Care System (PCS) software
Merlin" PCS 3650 programmer Model 3330 software Open, Classified |
PNJ | None listed |
| Jun 11, 2026 | Boston Scientific Neuromodulation Corporation Boston Scientific Model SC-4318, Clik X Anchor
REF: M365SC43180 Open, Classified |
LGW | None listed |
| Jun 10, 2026 | DT MedTech, LLC Hintermann Series Talar Implant, Left, Size 2
REF 302112 Open, Classified |
NTG | None listed |
| Jun 5, 2026 | INSPIREMD Inc CGuard Prime Carotid Stent System, 135cm, 10mmx40mm
Model/Catalog Number: CND1040 Open, Classified |
NIM | None listed |
| Jun 5, 2026 | INSPIREMD Inc CGuard Prime Carotid Stent System, 135cm, 10mmx30mm
Model/Catalog Number: CND1030 Open, Classified |
NIM | None listed |
| Jun 5, 2026 | INSPIREMD Inc Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm
Model/Catalog Number: CND0940 Open, Classified |
NIM | None listed |
| Jun 5, 2026 | INSPIREMD Inc CGuard Prime Carotid Stent System, 135cm, 9mx30mm
Model/Catalog Number: CND0930 Open, Classified |
NIM | None listed |
| Jun 5, 2026 | INSPIREMD Inc Brand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx40mm
Model/Catalog Number: CND0840 Open, Classified |
NIM | None listed |
| Jun 5, 2026 | INSPIREMD Inc Brand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx30mm
Model/Catalog Number: CND0830 Open, Classified |
NIM | None listed |
| Jun 5, 2026 | BERLIN 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 |
DSQ | None listed |
| Jun 1, 2026 | Advanced 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 |
MCM | None listed |
| May 28, 2026 | Medtronic Neuromodulation Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor Open, Classified |
MHY | None listed |
| May 28, 2026 | Medtronic Neuromodulation Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor Open, Classified |
MHY | None listed |
| May 28, 2026 | Abiomed, 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 |
OZD | None listed |
| May 22, 2026 | Abiomed, Inc. Automated Impella Controller (AIC);
Product Code: 0042-0000-US; Open, Classified |
OZD | None listed |
| May 22, 2026 | Bolton 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 |
MIH | None listed |
| May 14, 2026 | MICROVENTION 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 |
QCA | None listed |
| May 14, 2026 | Medtronic 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 |
LKK | None listed |
| May 13, 2026 | Edwards Lifesciences, LLC Edwards EVOQUE tricuspid delivery system
REF:9850TDS
Sterile EO Open, Classified |
NPW | None listed |
| May 12, 2026 | Hologic, 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 |
OTE | None listed |
| May 8, 2026 | On-X Life Technologies, Inc. On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33 Open, Classified |
LWQ | None listed |
| May 4, 2026 | Physio-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 |
MKJ | None listed |
| May 1, 2026 | Centinel Spine, Inc. Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6.
Total cervical disc replacement. Open, Classified |
MJO | None listed |
| May 1, 2026 | Centinel Spine, Inc. Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5
Total cervical disc replacement. Open, Classified |
MJO | None listed |
| Apr 27, 2026 | Advanced 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 |
MCM | None listed |
| Apr 24, 2026 | Medtronic, Inc. Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter. Open, Classified |
OAD | None listed |
| Apr 24, 2026 | Boston 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 |
NKE | None listed |
| Apr 24, 2026 | Boston 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 |
LWP | None listed |
| Apr 23, 2026 | Foundation 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 |
PQP | None listed |
| Apr 22, 2026 | Foundation Medicine, Inc. Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx) Open, Classified |
PQP | None listed |
| Apr 21, 2026 | Davol, Inc. Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030. Open, Classified |
LMF | None listed |
| Apr 16, 2026 | THERAKOS 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 |
LNR | None listed |
| Apr 2, 2026 | Medtronic MiniMed, Inc. MiniMed 530G Insulin Pump (MMT-551, MMT-751) Open, Classified |
OZO | None listed |
| Apr 2, 2026 | Medtronic MiniMed, Inc. Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723) Open, Classified |
OYC | None listed |
| Apr 2, 2026 | Medtronic MiniMed, Inc. Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722) Open, Classified |
OYC | None listed |
| Apr 2, 2026 | Medtronic MiniMed, Inc. MiniMed 620G Insulin Pump (MMT-1750) Open, Classified |
OYC | None listed |
| Apr 2, 2026 | Medtronic MiniMed, Inc. MiniMed 740G Insulin Pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862) Open, Classified |
OYC | None listed |
| Apr 2, 2026 | Medtronic MiniMed, Inc. MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867) Open, Classified |
OYC | None listed |
| Apr 2, 2026 | Medtronic MiniMed, Inc. MiniMed 640G Insulin Pump (MMT-1711, MMT-1712, MMT-1751, MMT-1752) Open, Classified |
OYC | None listed |
| Apr 2, 2026 | Medtronic MiniMed, Inc. MiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892) Open, Classified |
OZP | None listed |
| Apr 2, 2026 | Medtronic MiniMed, Inc. MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755) Open, Classified |
OZO | None listed |
| Apr 2, 2026 | Medtronic MiniMed, Inc. MiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782) Open, Classified |
OZP | None listed |
| Mar 31, 2026 | Abiomed, 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 |
OZD | None listed |
| Mar 27, 2026 | ReCor 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 |
QYI | None listed |
| Mar 27, 2026 | ReCor 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 |
QYI | None listed |
| Mar 27, 2026 | Abiomed, 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 |
OZD | None listed |
| Mar 24, 2026 | AMO 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 |
HQL | None listed |
| Mar 19, 2026 | Hologic, Inc. Brand Name: Aptima HPV Assay
Product Name: Aptima HPV Assay
Model/Catalog Number: 303585
Product Description: Aptima HPV assay
Component: No Open, Classified |
OYB | None listed |
| Mar 19, 2026 | LeMaitre Vascular, Inc. Artegraft Vascular Graft;
REF#: AG740; Open, Classified |
LXA | None listed |
| Mar 10, 2026 | Physio-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 |
MKJ | None listed |
| Mar 5, 2026 | Advanced Bionics, LLC Brand Name: HiResolution Bionic Ear System
Product Name: Sky CI M90 Sound Processor
Model/Catalog Number: CI-5295-150 Open, Classified |
MCM | None listed |
| Mar 2, 2026 | Staar Surgical AG EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5 Open, Classified |
QCB | None listed |
| Feb 27, 2026 | Abiomed, Inc. Impella RP. Product Code: 0046-0011. Open, Classified |
PYX | None 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