Nov 5, 2026
Z-0359-2027
LIAISON PLEX Gram-Negative Blood Culture Assay Catalog No. 20-005-303
Luminex Corporation
- NSU
- Class II
- Open, Classified
Device recalls
openFDA device enforcement reports, enriched with the device recall endpoint when a product code or CDRH recall id is available.
779 records
Nov 5, 2026
Z-0358-2027
Halyard ARTHROSCOPY PACK. Model/Catalog Number: SAMM014-21.
AVID Medical, Inc.
- LRO
- Class II
- Open, Classified
Nov 4, 2026
Z-0357-2027
intelerad IntelePACS software
INTELERAD MEDICAL SYSTEMS INCORPORATED
- LLZ
- Class II
- Open, Classified
Nov 4, 2026
Z-0328-2027
Senographe Pristina 3D
GE Medical Systems, LLC
- OTE
- Class III
- Open, Classified
Nov 4, 2026
Z-0327-2027
Senographe Pristina
GE Medical Systems, LLC
- MUE
- Class II
- Open, Classified
Nov 4, 2026
Z-0326-2027
Senographe Pristina
GE Medical Systems, LLC
- MUE
- Class II
- Open, Classified
Nov 4, 2026
Z-0315-2027
Carevo, Height-adjustable shower trolley, Model Number BAC1111-01
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
- FSA
- Class II
- Ongoing
Nov 4, 2026
Z-0314-2027
Precision Pointer Electromagnetic (8000-050-001)
Stryker Leibinger GmbH & Co. KG
- HAW
- Class II
- Ongoing
Nov 4, 2026
Z-0311-2027
Nalu TD2 Therapy Disc with firmware, REF: 34014-001, and TD2 Patient Kit, REF: 74011, part of the Nalu Neurostimulation System
Boston Scientific Neuromodulation Corporation
- GZB
- Class II
- Ongoing
Nov 4, 2026
Z-0310-2027
PENTAX Medical Water bottle assembly. Model Number. OS-H5.
Pentax of America Inc
- PEA
- Class II
- Ongoing
Nov 4, 2026
Z-0309-2027
PENTAX Medical Ultrasound Endoscope. Model Number. EG-3270UK.
Pentax of America Inc
- ODG
- Class II
- Ongoing
Nov 4, 2026
Z-0308-2027
PENTAX Medical Ultrasound Endoscope. Model Numbers. EG-3870UTK, EG-3670URK.
Pentax of America Inc
- ODG
- Class II
- Ongoing
Nov 4, 2026
Z-0307-2027
PENTAX Medical Ultrasound Endoscope. Model Numbers. EG38-J10UT, EG34-J10U.
Pentax of America Inc
- ODG
- Class II
- Ongoing
Nov 4, 2026
Z-0306-2027
PENTAX Medical Ultrasound Endoscope. Model Number. EG36-J10UR.
Pentax of America Inc
- ODG
- Class II
- Ongoing
Nov 4, 2026
Z-0304-2027
CareLink SmartSync Device Manager App, Model M01A02, Pulse generator, permanent, implantable
Medtronic, Inc.
- NVZ
- Class II
- Ongoing
Nov 4, 2026
Z-0303-2027
CareLink SmartSync, RF Head Patient Connector, Model 24967, Pulse generator, permanent, implantable
Medtronic, Inc.
- NVZ
- Class II
- Ongoing
Nov 4, 2026
Z-0302-2027
CareLink SmartSync Programmer, Model 24970A, Pulse generator, permanent, implantable
Medtronic, Inc.
- NVZ
- Class II
- Ongoing
Nov 4, 2026
Z-0301-2027
EMAG system Model/Catalog Number: 418591/418591U Product Description: Nucleic acid sample preparation instrument IVD, automated
BioMerieux SA
- JJH
- Class II
- Ongoing
Nov 4, 2026
Z-0300-2027
Philips Azurion S. Model Number: 722285.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- OWB
- Class II
- Ongoing
Nov 4, 2026
Z-0299-2027
Philips Azurion 7 M20. Model Numbers: 722079, 722224, 722282.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- OWB
- Class II
- Ongoing
Nov 4, 2026
Z-0298-2027
Philips Azurion 7 M12. Model Numbers: 722078, 722223.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- OWB
- Class II
- Ongoing
Nov 4, 2026
Z-0297-2027
Philips Azurion 7 B20. Model Numbers: 722068, 722226.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- OWB
- Class II
- Ongoing
Nov 4, 2026
Z-0296-2027
Philips Azurion 7 B12. Model Numbers: 722067, 722225.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- OWB
- Class II
- Ongoing
Nov 4, 2026
Z-0295-2027
Philips Azurion 5 M20. Model Numbers: 722228, 722281.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- OWB
- Class II
- Ongoing
Nov 4, 2026
Z-0294-2027
Philips Azurion 5 M12. Model Number: 722227.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- OWB
- Class II
- Ongoing