Aug 26, 2026
Z-2962-2026
Suture Cinch Long 1pk. Endoscopic tissue approximation device.
Boston Scientific Corporation
- Class II
- Ongoing
Device recalls
openFDA device enforcement reports, enriched with the device recall endpoint when a product code or CDRH recall id is available.
779 records
Aug 26, 2026
Z-2961-2026
OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
Boston Scientific Corporation
- Class II
- Ongoing
Aug 26, 2026
Z-2960-2026
TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799
Tobii Dynavox Llc
- Class II
- Ongoing
Aug 26, 2026
Z-2959-2026
TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798
Tobii Dynavox Llc
- Class II
- Ongoing
Aug 26, 2026
Z-2958-2026
Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-253530, 21-253533, 21-253535, 21-253540, 21-253545, 21-253550, 21-353513, 21-353516, 27-…
Arrowhead DE LLC
- Class II
- Ongoing
Aug 26, 2026
Z-2957-2026
Brand Name: Kico Knee Innovation Product Name: ARVIS SURGICAL NAVIGATION SYSTEM GEN 2 Model/Catalog Number: IN-29200 Software Version: ARVIS Hip and Knee Gap B…
Kico Knee Innovation Company
- Class II
- Ongoing
Aug 26, 2026
Z-2956-2026
Cardiac Workstation 7000. Product Number: 860441.
Philips North America Llc
- Class II
- Ongoing
Aug 26, 2026
Z-2955-2026
Cardiac Workstation 5000. Product Number: 860439.
Philips North America Llc
- Class II
- Ongoing
Aug 26, 2026
Z-2954-2026
Dentsply Sirona Capsule Mixer Model No. 5546068
SDI Limited
- Class II
- Ongoing
Aug 26, 2026
Z-2953-2026
One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
Intersurgical Inc
- Class II
- Ongoing
Aug 26, 2026
Z-2952-2026
One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.
Intersurgical Inc
- Class II
- Ongoing
Aug 26, 2026
Z-2951-2026
Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.
Foundation Medicine, Inc.
- Class II
- Ongoing
Aug 26, 2026
Z-2950-2026
EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 05391530810166 DL…
Covidien, LLC
- Class II
- Ongoing
Aug 26, 2026
Z-2940-2026
Ami HTX
Spectral Instruments Inc
- Class II
- Ongoing
Aug 26, 2026
Z-2939-2026
Lago X
Spectral Instruments Inc
- Class II
- Ongoing
Aug 26, 2026
Z-2872-2026
BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered Driver 25mm x 15Ga, REF: D015251NK, BD Needle Kit for Powered Driver 35…
Bard Access Systems, Inc.
- Class I
- Ongoing
Aug 19, 2026
Z-2949-2026
Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Number: SBA73BPGCA; 2) SPINE PACK , Catalog Number: SNE11SPHKC; 3) SPINE PACK , Catalog Number: SNE11SP…
Cardinal Health 200, LLC
- Class II
- Ongoing
Aug 19, 2026
Z-2948-2026
Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH4; 3) KIT,CHP BASIC NEURO…
Cardinal Health 200, LLC
- Class II
- Ongoing
Aug 19, 2026
Z-2947-2026
Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC27; 2) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC28; 3) CHI ST…
Cardinal Health 200, LLC
- Class II
- Ongoing
Aug 19, 2026
Z-2946-2026
Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Number: SEN73NSKCF; 2) PACK NEURO MINOR CRANIOTOMY , Catalog Number: SNE30CNOHE; 3) NEURO MAJOR 2…
Cardinal Health 200, LLC
- Class II
- Ongoing
Aug 19, 2026
Z-2945-2026
Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA; 3) KIT,SINUS , Catalog Number: PE13SPAJB; 4)…
Cardinal Health 200, LLC
- Class II
- Ongoing
Aug 19, 2026
Z-2944-2026
Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB
Cardinal Health 200, LLC
- Class II
- Ongoing
Aug 19, 2026
Z-2943-2026
Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC
Cardinal Health 200, LLC
- Class II
- Ongoing
Aug 19, 2026
Z-2942-2026
Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Catalog Number: 21-4720C; 3) KIT,BOSC MICROLARYNGOSCOP…
Cardinal Health 200, LLC
- Class II
- Ongoing
Aug 19, 2026
Z-2941-2026
60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C UDI-DI code: 10885403274619…
BD SWITZERLAND SARL
- Class II
- Ongoing