Oct 28, 2026
Z-0268-2027
Xact mole marker for mammography Model/Catalog Number: M15RM
Solstice Corporation
- JAC
- 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
Oct 28, 2026
Z-0267-2027
InterStim Percutaneous Extensions EXT 3560022 ISTM II PERC 3560022 EXT 3560030 ISTM MICRO PERC 3560030
Medtronic Neuromodulation
- EZW
- Class II
- Ongoing
Oct 28, 2026
Z-0266-2027
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…
Medtronic Neuromodulation
- QON
- Class II
- Ongoing
Oct 28, 2026
Z-0265-2027
Generic Name: MiniMed Go App Generic Name: MiniMed Go App Model/Catalog Number: MMT-8600 (iOS), MMT-8601 (Android) Software Version: Software version 1.2.1 Pro…
Medtronic MiniMed, Inc.
- NDC
- Class II
- Ongoing
Oct 28, 2026
Z-0264-2027
Generic Name: restor3d MTP Implant Generic Name: MTP Implant Model/Catalog Number: 1103-161620 Software Version: None Product Description: The restor3d Metatar…
restor3d Inc.
- KWD
- Class II
- Ongoing
Oct 28, 2026
Z-0263-2027
Direxion Torqueable Microcatheter, NGMC/TRANSEND/027/BERN/1RO/130; Material Number: M001195940
Boston Scientific Cork, Ltd.
- KRA
- Class II
- Ongoing
Oct 28, 2026
Z-0262-2027
Direxion Torqueable Microcatheter, NGMC/TRANSEND/027/STRAIGHT/1RO/130; Material Number: M001195910
Boston Scientific Cork, Ltd.
- KRA
- Class II
- Ongoing
Oct 28, 2026
Z-0261-2027
Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/155; Material Number: M001195850
Boston Scientific Cork, Ltd.
- KRA
- Class II
- Ongoing
Oct 28, 2026
Z-0260-2027
Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/130; Material Number: M001195840
Boston Scientific Cork, Ltd.
- KRA
- Class II
- Ongoing
Oct 28, 2026
Z-0259-2027
Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/STRAIGHT/1RO/130; Material Number: M001195810
Boston Scientific Cork, Ltd.
- KRA
- Class II
- Ongoing
Oct 28, 2026
Z-0258-2027
Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/155; Material Number: M001195750
Boston Scientific Cork, Ltd.
- KRA
- Class II
- Ongoing
Oct 28, 2026
Z-0257-2027
Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/130; Material Number: M001195740
Boston Scientific Cork, Ltd.
- KRA
- Class II
- Ongoing
Oct 28, 2026
Z-0256-2027
Direxion Torqueable Microcatheter, NGMC/FATHOM/027/STRAIGHT/1RO/155; Material Number: M001195720
Boston Scientific Cork, Ltd.
- KRA
- Class II
- Ongoing
Oct 28, 2026
Z-0255-2027
Direxion Torqueable Microcatheter, NGMC/FATHOM/027/STRAIGHT/1RO/130; Material Number: M001195710
Boston Scientific Cork, Ltd.
- KRA
- Class II
- Ongoing
Oct 28, 2026
Z-0254-2027
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/2RO/130; Material Number: M001195670
Boston Scientific Cork, Ltd.
- KRA
- Class II
- Ongoing
Oct 28, 2026
Z-0253-2027
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/2RO/130; Material Number: M001195660
Boston Scientific Cork, Ltd.
- KRA
- Class II
- Ongoing
Oct 28, 2026
Z-0252-2027
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/1RO/155; Material Number: M001195650
Boston Scientific Cork, Ltd.
- KRA
- Class II
- Ongoing
Oct 28, 2026
Z-0251-2027
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/1RO/130; Material Number: M001195640
Boston Scientific Cork, Ltd.
- KRA
- Class II
- Ongoing
Oct 28, 2026
Z-0250-2027
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/155; Material Number: M001195620
Boston Scientific Cork, Ltd.
- KRA
- Class II
- Ongoing
Oct 28, 2026
Z-0249-2027
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/130; Material Number: M001195610
Boston Scientific Cork, Ltd.
- KRA
- Class II
- Ongoing
Oct 28, 2026
Z-0248-2027
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/155; Material Number: M001195510
Boston Scientific Cork, Ltd.
- KRA
- Class II
- Ongoing
Oct 28, 2026
Z-0247-2027
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/130; Material Number: M001195500
Boston Scientific Cork, Ltd.
- KRA
- Class II
- Ongoing
Oct 28, 2026
Z-0246-2027
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/J/1RO/155; Material Number: M001195480
Boston Scientific Cork, Ltd.
- KRA
- Class II
- Ongoing
Oct 28, 2026
Z-0245-2027
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/J/1RO/130; Material Number: M001195470
Boston Scientific Cork, Ltd.
- KRA
- Class II
- Ongoing
Oct 28, 2026
Z-0244-2027
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/155; Material Number: M001195450
Boston Scientific Cork, Ltd.
- KRA
- Class II
- Ongoing