ClearanceBrief

Latest device recalls

Newest first, 50 per page. Open a recall to see the 510(k) clearances it names.

DateFirm and productCodeLinked 510(k)
Oct 21, 2026Beckman 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
JQCNone listed
Oct 21, 2026Medtronic MiniMed, Inc.
CareLink Clinic, REF: MMT-7350
Open, Classified
PHVNone listed
Oct 21, 2026Greiner 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
JKAK960857
Oct 20, 2026Ventec Life Systems, Inc.
V*Home, Model Number: PRT-01444-000, Package PN:PRT-01445-000. used for ventilatory support.
Open, Classified
CBKNone listed
Oct 20, 2026Ventec 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
CBKK162877
Oct 20, 2026Ventec Life Systems, Inc.
VC(Japan) Model Number: PRT-01098-100, Package PN:PRT-01125-100. used for ventilatory support.
Open, Classified
CBKK162877
Oct 20, 2026Ventec Life Systems, Inc.
VC Model Number: PRT-01098-000, Package PN:PRT-01125-000. used for ventilatory support.
Open, Classified
CBKK162877
Oct 20, 2026Ventec 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
CBKK162877
Oct 20, 2026Ventec Life Systems, Inc.
VCSN+Pro Model Number: PRT-01184-000, Package PN:PRT-01172-000. used for ventilatory support.
Open, Classified
CBKK162877
Oct 20, 2026Ventec Life Systems, Inc.
VOCSN (Japan) Model Number: PRT-01100-100, Package PN:PRT-01126-100. used for ventilatory support.
Open, Classified
CBKK162877
Oct 20, 2026Ventec Life Systems, Inc.
VOCSN Model Number: PRT-01100-000, Package PN:PRT-01126-000. used for ventilatory support.
Open, Classified
CBKK162877
Oct 20, 2026Ventec Life Systems, Inc.
VC+Pro (Japan) Model Number: PRT-00900-100, Package PN:PRT-00973-100. used for ventilatory support.
Open, Classified
CBKK162877
Oct 20, 2026Ventec Life Systems, Inc.
VC+Pro Model Number: PRT-00900-001, Package PN:PRT-00973-000. used for ventilatory support.
Open, Classified
CBKK162877
Oct 20, 2026Ventec Life Systems, Inc.
VOCSN+Pro (Japan), Model Number: PRT-00490-100, Package PN:PRT-00853-100. used for ventilatory support.
Open, Classified
CBKK162877
Oct 20, 2026Ventec Life Systems, Inc.
VOCSN+Pro, Model Number:PRT-00490-001, Package PN:PRT-00853-000. used for ventilatory support.
Open, Classified
CBKK162877
Oct 16, 2026Philips North America
Philips Smart-hopping 2.0 AP 1.4 GHz; Product/Model Number: 867216;
Open, Classified
MHXNone listed
Oct 16, 2026Axonics, Inc.
PNE Lead Implant Kit REF: 1701
Open, Classified
EZWNone listed
Oct 16, 2026Medtronic Navigation, Inc.
Medtronic Biopsy Needle Kit, REF: 9733068, Passive, Sterile EO, Rxonly
Open, Classified
HAWK971247
Oct 16, 2026Medtronic Navigation, Inc.
Medtronic NDI Passive Spheres REF: 8801075, Sterile EO, 5/Tray 12 Pk., Rxonly
Open, Classified
HAWK033621
Oct 16, 2026Medtronic Navigation, Inc.
Medtronic NDI Passive Spheres REF: 8801074, Sterile EO, 4/Tray 12 Pk., Rxonly
Open, Classified
HAWK033621
Oct 16, 2026Medtronic Navigation, Inc.
Medtronic NDI Passive Spheres REF: 8801071, Sterile EO, 1/Tray 12 pk., Rxonly
Open, Classified
HAWK033621
Oct 16, 2026B Braun Medical Inc
B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP. Catalog Number: 415068.
Open, Classified
FPAK942988
Oct 16, 2026Philips Ultrasound, LLC
Philips Lumify Diagnostic Ultrasound System
Open, Classified
IYNK242519
K242670
Oct 16, 2026Think Surgical, Inc.
Think Surgical Square Driver REF: 109126
Open, Classified
OLOK261024
Oct 16, 2026Abbott
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
NGVNone listed
Oct 15, 2026Medline Industries, LP
Medline convenience kit labeled as: FOOT ANKLE. Medline Kit SKU DYNJ65395A
Open, Classified
KCYNone listed
Oct 15, 2026Healthmark 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
MDMNone listed
Oct 15, 2026Merit 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
NEUK252892
Oct 15, 2026INTELERAD 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
LLZK192176
Oct 15, 2026Medline Industries, LP
Convenience Kits containing CONMED AirSeal Access Ports KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116G
Open, Classified
OKVNone listed
Oct 15, 2026Medline Industries, LP
Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911135A CHN GYN ONCOLOGY DYNJ906731M
Open, Classified
OJFNone listed
Oct 15, 2026Medline Industries, LP
Convenience Kits containing CONMED AirSeal Access Ports CHN GYN ONCOLOGY DYNJ906731K DYNJ906731L DYNJ906731N DAVINCI PROSTATECTOMY DYNJG901002A DYNJG901002B DYNJG901002C
Open, Classified
OHDNone listed
Oct 15, 2026Medline Industries, LP
Convenience Kits containing CONMED AirSeal Access Ports GENERAL DAVINCI DYNJG901004C LAP CHOLE DYNJ88071 ROBOTIC PACK DYNJ50474F
Open, Classified
LRONone listed
Oct 15, 2026Medline 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
LRONone listed
Oct 15, 2026Medline Industries, LP
Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911135 LAP CHOLE DYNJ911660 LAP NISSEN DYNJ911560 UROLOGY LAPAROSCOPIC - 51638 DYNJ908720A
Open, Classified
FDENone listed
Oct 15, 2026Medline 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
OJHNone listed
Oct 15, 2026Medline Industries, LP
Medline surgical convenience kits labeled as: OPEN HEART, Medline Product Number/SKU DYNJ902898D
Open, Classified
OJKNone listed
Oct 15, 2026Medline 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
OJGNone listed
Oct 15, 2026Medline 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
LRONone listed
Oct 15, 2026Medline 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
KDDNone listed
Oct 15, 2026Medline 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
FDENone listed
Oct 15, 2026Medline 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
OGRNone listed
Oct 15, 2026Medline Industries, LP
Medline surgical convenience kits labeled as: VEIN HARVESTING PACK, Medline product number/SKU DYNJ51845D
Open, Classified
OFGNone listed
Oct 15, 2026Medline 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
OFFNone listed
Oct 15, 2026Medline 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
OEZNone listed
Oct 15, 2026Medline 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
OESNone listed
Oct 15, 2026Medline Industries, LP
Medline surgical convenience kits labeled as: CABG AUXILIARY PACK, Medline Product Number/SKU DYNJ44925D
Open, Classified
OEQNone listed
Oct 15, 2026Howmedica Osteonics Corp.
TS Misc. Instruments Tray, Triathlon. Catalog Number: 6543-6-519.
Open, Classified
FSMNone listed
Oct 15, 2026Howmedica Osteonics Corp.
Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514.
Open, Classified
FSMNone listed
Oct 15, 2026Howmedica Osteonics Corp.
TS Femoral Prep Tray, Triathlon. Catalog Number: 6543-6-507.
Open, Classified
FSMNone listed