Latest device recalls
Newest first, 50 per page. Open a recall to see the 510(k) clearances it names.
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 22, 2026 | Medtronic MiniMed, Inc. 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
Product Description: The MiniMed Go app for Open, Classified |
NDC | K253512 |
| Oct 22, 2026 | restor3d Inc. Generic Name: restor3d MTP Implant
Generic Name: MTP Implant
Model/Catalog Number: 1103-161620
Software Version: None
Product Description: The restor3d Metatarsophalangeal (MTP) Implant is a sterile, Open, Classified |
KWD | K201393 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/TRANSEND/027/BERN/1RO/130;
Material Number: M001195940 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/TRANSEND/027/STRAIGHT/1RO/130;
Material Number: M001195910 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/155;
Material Number: M001195850 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/130;
Material Number: M001195840 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/STRAIGHT/1RO/130;
Material Number: M001195810 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/155;
Material Number: M001195750 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/130;
Material Number: M001195740 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/027/STRAIGHT/1RO/155;
Material Number: M001195720 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/027/STRAIGHT/1RO/130;
Material Number: M001195710 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/2RO/130;
Material Number: M001195670 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/2RO/130;
Material Number: M001195660 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/1RO/155;
Material Number: M001195650 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/1RO/130;
Material Number: M001195640 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/155;
Material Number: M001195620 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/130;
Material Number: M001195610 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/155;
Material Number: M001195510 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/130;
Material Number: M001195500 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/J/1RO/155;
Material Number: M001195480 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/J/1RO/130;
Material Number: M001195470 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/155;
Material Number: M001195450 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/130;
Material Number: M001195440 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/105;
Material Number: M001195430 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/155;
Material Number: M001195420 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/130;
Material Number: M001195410 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/105;
Material Number: M001195400 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/2RO/155;
Material Number: M001195350 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/2RO/130;
Material Number: M001195340 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/2RO/155;
Material Number: M001195330 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/2RO/130;
Material Number: M001195320 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/155;
Material Number: M001195310 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/130;
Material Number: M001195300 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/105;
Material Number: M001195290 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/155;
Material Number: M001195280 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/130;
Material Number: M001195270 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/105;
Material Number: M001195260 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/155;
Material Number: M001195250 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/130;
Material Number: M001195240 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/105;
Material Number: M001195230 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/155;
Material Number: M001195220 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/130;
Material Number: M001195210 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | CooperVision, Inc. Generic Name: Softmed Breathables Advanced Toric (fanfilcon A) Soft (Hydrophilic) Contact Lens;
Model/Catalog Number: Softmed Breathables Advanced Toric
Product Description: 55% water content, toric, Open, Classified |
LPL | K160803 K213164 +1 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/105;
Material Number: M001195200 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Life Technologies Holdings Pte Ltd Ion Torrent Genexus Dx with software, Catalog: A40003539, which supports the Ion Torrent Genexus Dx Integrated Sequencer Open, Classified |
PFF | None listed |
| Oct 22, 2026 | TECHNO-PATH MANUFACTURING LTD. Techno-Path Multichem AE Unassayed Level 3, REF:AE623X Open, Classified |
OHQ | None listed |
| Oct 22, 2026 | TECHNO-PATH MANUFACTURING LTD. Techno-Path Multichem AE Unassayed Level 2
REF: AE622X Open, Classified |
OHQ | None listed |
| Oct 22, 2026 | TECHNO-PATH MANUFACTURING LTD. Techno-Path Multichem AE Unassayed Level 1
REF:AE621X Open, Classified |
OHQ | None listed |
| Oct 21, 2026 | Beckman Coulter, Inc. ROTOR ASSY-SW41, Reference Number 331362, when the rotors are installed in the following centrifuges: Optima XPN-100 (Model Numbers A99846 and A94469), Optima XPN-90 (Model Numbers A99842 and A94468), Open, Classified |
JQC | None listed |