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 21, 2026 | Beckman Coulter, Inc. ROTOR ASSY-SW40, Reference Number 331302, 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 |
| Oct 21, 2026 | Medtronic MiniMed, Inc. CareLink Clinic, REF: MMT-7350 Open, Classified |
PHV | None listed |
| Oct 21, 2026 | Greiner Bio-One North America, Inc. Brand Name: VACUETTE
Product Name: LH Lithium Heparin Separator
Model/Catalog Number: 454008P
Product Description: Greiner VACUETTE Blood Collection Tube with Lithium Heparin and Gel Separator (13 x 7 Open, Classified |
JKA | K960857 |
| Oct 20, 2026 | Ventec Life Systems, Inc. V*Home, Model Number: PRT-01444-000, Package PN:PRT-01445-000. used for ventilatory support. Open, Classified |
CBK | None listed |
| Oct 20, 2026 | Ventec Life Systems, Inc. V+ Pro Emergency, Model Number: PRT-01201-000, Package PN:PRT-01173-000,PRT-01222-000. used for ventilatory support. Open, Classified |
CBK | K162877 |
| Oct 20, 2026 | Ventec Life Systems, Inc. VC(Japan)
Model Number: PRT-01098-100, Package PN:PRT-01125-100. used for ventilatory support. Open, Classified |
CBK | K162877 |
| Oct 20, 2026 | Ventec Life Systems, Inc. VC
Model Number: PRT-01098-000, Package PN:PRT-01125-000. used for ventilatory support. Open, Classified |
CBK | K162877 |
| Oct 20, 2026 | Ventec Life Systems, Inc. V+Pro
Model Number: PRT-01185-000, Package PN:PRT-01198-000; Model Number: PRT-01185-001, Package PN: N/A; Model Number: PRT-01185-002, Package PN:N/A. used for ventilatory support. Open, Classified |
CBK | K162877 |
| Oct 20, 2026 | Ventec Life Systems, Inc. VCSN+Pro
Model Number: PRT-01184-000, Package PN:PRT-01172-000. used for ventilatory support. Open, Classified |
CBK | K162877 |
| Oct 20, 2026 | Ventec Life Systems, Inc. VOCSN (Japan)
Model Number: PRT-01100-100, Package PN:PRT-01126-100. used for ventilatory support. Open, Classified |
CBK | K162877 |
| Oct 20, 2026 | Ventec Life Systems, Inc. VOCSN
Model Number: PRT-01100-000, Package PN:PRT-01126-000. used for ventilatory support. Open, Classified |
CBK | K162877 |
| Oct 20, 2026 | Ventec Life Systems, Inc. VC+Pro (Japan)
Model Number: PRT-00900-100, Package PN:PRT-00973-100. used for ventilatory support. Open, Classified |
CBK | K162877 |
| Oct 20, 2026 | Ventec Life Systems, Inc. VC+Pro
Model Number: PRT-00900-001, Package PN:PRT-00973-000. used for ventilatory support. Open, Classified |
CBK | K162877 |
| Oct 20, 2026 | Ventec Life Systems, Inc. VOCSN+Pro (Japan),
Model Number: PRT-00490-100, Package PN:PRT-00853-100. used for ventilatory support. Open, Classified |
CBK | K162877 |
| Oct 20, 2026 | Ventec Life Systems, Inc. VOCSN+Pro,
Model Number:PRT-00490-001, Package PN:PRT-00853-000. used for ventilatory support. Open, Classified |
CBK | K162877 |
| Oct 16, 2026 | Philips North America Philips Smart-hopping 2.0 AP 1.4 GHz;
Product/Model Number: 867216; Open, Classified |
MHX | None listed |
| Oct 16, 2026 | Axonics, Inc. PNE Lead Implant Kit
REF: 1701 Open, Classified |
EZW | None listed |
| Oct 16, 2026 | Medtronic Navigation, Inc. Medtronic Biopsy Needle Kit, REF: 9733068, Passive, Sterile EO, Rxonly Open, Classified |
HAW | K971247 |
| Oct 16, 2026 | Medtronic Navigation, Inc. Medtronic NDI Passive Spheres
REF: 8801075, Sterile EO, 5/Tray 12 Pk., Rxonly Open, Classified |
HAW | K033621 |
| Oct 16, 2026 | Medtronic Navigation, Inc. Medtronic NDI Passive Spheres
REF: 8801074, Sterile EO, 4/Tray 12 Pk., Rxonly Open, Classified |
HAW | K033621 |
| Oct 16, 2026 | Medtronic Navigation, Inc. Medtronic NDI Passive Spheres
REF: 8801071, Sterile EO, 1/Tray 12 pk., Rxonly Open, Classified |
HAW | K033621 |
| Oct 16, 2026 | B Braun Medical Inc B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP. Catalog Number: 415068. Open, Classified |
FPA | K942988 |
| Oct 16, 2026 | Philips Ultrasound, LLC Philips Lumify Diagnostic Ultrasound System Open, Classified |
IYN | K242519 K242670 |
| Oct 16, 2026 | Think Surgical, Inc. Think Surgical Square Driver
REF: 109126 Open, Classified |
OLO | K261024 |
| 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 15, 2026 | Medline Industries, LP Medline convenience kit labeled as: FOOT ANKLE. Medline Kit SKU DYNJ65395A Open, Classified |
KCY | None listed |
| Oct 15, 2026 | Healthmark Industries Co., Inc. Vinyl Instrument Guards, labeled as: 1) VENTED INSTRUMENT GUARD 1/16 X 3/4H - WHITE, Model Number 09-1-011; 2) WHITE VENTED INSTRUMENT GUARD 1/16 X 3/4, Model Number 09-1-011; 3) VENTED INSTRUMENT GUA Open, Classified |
MDM | None listed |
| Oct 15, 2026 | Merit Medical Systems, Inc. Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01
Contents: (1) Scout MD Delivery System, Standard for use with the SCOUT MD Surgical Guidance System, Rx Only, Sterile-EO Open, Classified |
NEU | K252892 |
| Oct 15, 2026 | INTELERAD MEDICAL SYSTEMS INCORPORATED IntelePACS, InteleConnect Portal/Tech Portal Versions PACS-5-1-1-R102, PACS-5-2-1-R93, PACS-5-3-1-R83 through R128, PACS-5-4-1-R66 through R101, PACS-5-5-1-R50 through R89, PACS-5-6-1-R41 through R81, Open, Classified |
LLZ | K192176 |
| Oct 15, 2026 | Medline Industries, LP Convenience Kits containing CONMED AirSeal Access Ports
KIT ROBOTICS UROLOGY PROSTATE
DYKMBNDL116G Open, Classified |
OKV | None listed |
| Oct 15, 2026 | Medline Industries, LP Convenience Kits containing CONMED AirSeal Access Ports
ADVANCE LAPAROSCOPIC
DYNJ911135A
CHN GYN ONCOLOGY
DYNJ906731M Open, Classified |
OJF | None listed |
| Oct 15, 2026 | Medline Industries, LP Convenience Kits containing CONMED AirSeal Access Ports
CHN GYN ONCOLOGY
DYNJ906731K
DYNJ906731L
DYNJ906731N
DAVINCI PROSTATECTOMY
DYNJG901002A
DYNJG901002B
DYNJG901002C
Open, Classified |
OHD | None listed |
| Oct 15, 2026 | Medline Industries, LP Convenience Kits containing CONMED AirSeal Access Ports
GENERAL DAVINCI
DYNJG901004C
LAP CHOLE
DYNJ88071
ROBOTIC PACK
DYNJ50474F Open, Classified |
LRO | None listed |
| Oct 15, 2026 | Medline Industries, LP Convenience Kits containing CONMED AirSeal Access Ports
HERNANDEZ DAVINCI ACC BUNDLE M
DYNJ911258
KIT ROBOTICS UROLOGY PROSTATE
DYKMBNDL116I
ROBOTIC CHEST
DYNJ910997
DYNJ910997A
RR-DAVINCI Open, Classified |
LRO | None listed |
| Oct 15, 2026 | Medline Industries, LP Convenience Kits containing CONMED AirSeal Access Ports
ADVANCE LAPAROSCOPIC
DYNJ911135
LAP CHOLE
DYNJ911660
LAP NISSEN
DYNJ911560
UROLOGY LAPAROSCOPIC - 51638
DYNJ908720A Open, Classified |
FDE | None listed |
| Oct 15, 2026 | Medline Industries, LP Medline surgical convenience kits labeled as:
1) SPINAL CDS, Medline Product Number/SKU CDS940087AM;
2) CUSTOM CRANI, Medline Product Number/SKU DYNJ907697C;
3) FEM POP PACK-LF, Medline Product Nu Open, Classified |
OJH | None listed |
| Oct 15, 2026 | Medline Industries, LP Medline surgical convenience kits labeled as: OPEN HEART, Medline Product Number/SKU DYNJ902898D Open, Classified |
OJK | None listed |
| Oct 15, 2026 | Medline Industries, LP Medline surgical convenience kits labeled as:
1) NEURO-SPINE BASIN PACK, Medline Product Number/SKU DYNJ80055A;
2) AV SHUNT PACK-LF, Medline Product Number/SKU DYNJ24528M. Open, Classified |
OJG | None listed |
| Oct 15, 2026 | Medline Industries, LP Medline surgical convenience kits labeled as: 1) OPEN HEART PACK A & B, Medline Product number/SKU DYNJ04584L; 2) OPEN HEART ACCESSORY PACK, Medline Product number/SKU DYNJT5715A; 3) CABG ACCESSORY PA Open, Classified |
LRO | None listed |
| Oct 15, 2026 | Medline Industries, LP Medline surgical convenience kits labeled as:
1) CV BASIN PACK-LF, Medline Product number/SKU DYNJ0538615K;
2) CV BASIN PACK-LF, Medline product number/SKU DYNJ0538615J;
3) CV BASIN PACK-LF, Medl Open, Classified |
KDD | None listed |
| Oct 15, 2026 | Medline Industries, LP Medline surgical convenience kits labeled as:
1) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274AC;
2) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274A Open, Classified |
FDE | None listed |
| Oct 15, 2026 | Medline Industries, LP Medline surgical convenience kits labeled as:
1) EAR, Medline product number/SKU DYNJ909020B;
2) EAR, Medline product number/SKU DYNJ909020A;
3) CAROTID PACK, Medline product number/SKU DYNJ42922C Open, Classified |
OGR | None listed |
| Oct 15, 2026 | Medline Industries, LP Medline surgical convenience kits labeled as: VEIN HARVESTING PACK, Medline product number/SKU DYNJ51845D Open, Classified |
OFG | None listed |
| Oct 15, 2026 | Medline Industries, LP Medline surgical convenience kits labeled as:
1) VEIN HARVESTING PACK-LF, Medline product number/SKU DYNJ0826732J;
2) NBMC VASCULAR PACK-LF, Medline product number/SKU DYNJ0665837G;
3) AV FISTULA, Open, Classified |
OFF | None listed |
| Oct 15, 2026 | Medline Industries, LP Medline surgical convenience kits labeled as:
1) OPEN HEART CDS, Medline product number/SKU CDS840094R;
2) OPEN HEART CDS, Medline product number/SKU CDS840171AG;
3) MHC AV FISTULA, Medline produc Open, Classified |
OEZ | None listed |
| Oct 15, 2026 | Medline Industries, LP 1) Product Name AUD OPEN HEART PACK, Medline Kit Number/SKU DYNJ22052I;
2) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Number/SKU DYNJ24528N;
3) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Open, Classified |
OES | None listed |
| Oct 15, 2026 | Medline Industries, LP Medline surgical convenience kits labeled as: CABG AUXILIARY PACK, Medline Product Number/SKU DYNJ44925D Open, Classified |
OEQ | None listed |
| Oct 15, 2026 | Howmedica Osteonics Corp. TS Misc. Instruments Tray, Triathlon. Catalog Number: 6543-6-519. Open, Classified |
FSM | None listed |
| Oct 15, 2026 | Howmedica Osteonics Corp. Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514. Open, Classified |
FSM | None listed |
| Oct 15, 2026 | Howmedica Osteonics Corp. TS Femoral Prep Tray, Triathlon. Catalog Number: 6543-6-507. Open, Classified |
FSM | None listed |