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 30, 2026Accriva Diagnostics, Inc.
Hemochron Jr., Whole Blood Microcoagulation System, Activated Partial Thromboplastin Time (APTT) Test Cuvette, REF: J103
Open, Classified		 JPAK940401
Oct 30, 2026Tandem Diabetes Care, Inc.
Tandem Mobi Insulin Pump, Models: 1004004, 1010750, 1012676, 1012719, 1013655, 1013656, 1013501, 1013700, 1014081, 1014801, 1014811, 1014813, 1014936, 1016911, 1016912, 1016913, 1016914, 1018075, 1018
Open, Classified		 QFGK223213
K233044 +3
Oct 29, 2026ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Carevo, Height-adjustable shower trolley, Model Number BAC1111-01
Open, Classified		 FSANone listed
Oct 29, 2026Stryker Leibinger GmbH & Co. KG
Precision Pointer Electromagnetic (8000-050-001)
Open, Classified		 HAWK212194
Oct 29, 2026Boston Scientific Neuromodulation Corporation
Nalu TD2 Therapy Disc with firmware, REF: 34014-001, and TD2 Patient Kit, REF: 74011, part of the Nalu Neurostimulation System
Open, Classified		 GZBK233801
Oct 28, 2026Pentax of America Inc
PENTAX Medical Water bottle assembly. Model Number. OS-H5.
Open, Classified		 PEAK191282
Oct 28, 2026Pentax of America Inc
PENTAX Medical Ultrasound Endoscope. Model Number. EG-3270UK.
Open, Classified		 ODGK182004
Oct 28, 2026Pentax of America Inc
PENTAX Medical Ultrasound Endoscope. Model Numbers. EG-3870UTK, EG-3670URK.
Open, Classified		 ODGK182004
Oct 28, 2026Pentax of America Inc
PENTAX Medical Ultrasound Endoscope. Model Numbers. EG38-J10UT, EG34-J10U.
Open, Classified		 ODGK200090
Oct 28, 2026Pentax of America Inc
PENTAX Medical Ultrasound Endoscope. Model Number. EG36-J10UR.
Open, Classified		 ODGK200090
Oct 28, 2026Abiomed, Inc.
Impella Connect Optical AIC, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pump.
Open, Classified		 OZDNone listed
Oct 28, 2026Abiomed, Inc.
Impella Optical Controller, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pump.
Open, Classified		 OZDNone listed
Oct 28, 2026Abiomed, Inc.
Automated Impella Controller, Packaged. Primary user control interface for the Impella Catheter, catheter-based heart pump.
Open, Classified		 OZDNone listed
Oct 27, 2026Medtronic, Inc.
CareLink SmartSync Device Manager App, Model M01A02, Pulse generator, permanent, implantable
Open, Classified		 NVZNone listed
Oct 27, 2026Medtronic, Inc.
CareLink SmartSync, RF Head Patient Connector, Model 24967, Pulse generator, permanent, implantable
Open, Classified		 NVZNone listed
Oct 27, 2026Medtronic, Inc.
CareLink SmartSync Programmer, Model 24970A, Pulse generator, permanent, implantable
Open, Classified		 NVZNone listed
Oct 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion S. Model Number: 722285.
Open, Classified		 OWBK172822
K181830 +1
Oct 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 7 M20. Model Numbers: 722079, 722224, 722282.
Open, Classified		 OWBK172822
K181830 +1
Oct 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 7 M12. Model Numbers: 722078, 722223.
Open, Classified		 OWBK172822
K181830 +1
Oct 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 7 B20. Model Numbers: 722068, 722226.
Open, Classified		 OWBK172822
K181830 +1
Oct 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 7 B12. Model Numbers: 722067, 722225.
Open, Classified		 OWBK172822
K181830 +1
Oct 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 5 M20. Model Numbers: 722228, 722281.
Open, Classified		 OWBK172822
K181830 +1
Oct 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 5 M12. Model Number: 722227.
Open, Classified		 OWBK172822
K181830 +1
Oct 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 3 M15. Model Number: 722064, 722222, 722280.
Open, Classified		 OWBK172822
K181830 +1
Oct 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 3 M12. Model Numbers: 722063, 722221.
Open, Classified		 OWBK172822
K181830 +1
Oct 27, 2026BioMerieux SA
EMAG system Model/Catalog Number: 418591/418591U Product Description: Nucleic acid sample preparation instrument IVD, automated
Open, Classified		 JJHNone listed
Oct 27, 2026Canon Medical System, USA, INC.
ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000V
Open, Classified		 OWBK203551
K233107
Oct 27, 2026Canon Medical System, USA, INC.
ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000F
Open, Classified		 OWBK182415
Oct 27, 2026Canon Medical System, USA, INC.
ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000C
Open, Classified		 OWBK210900
Oct 26, 2026Philips North America
Model Number: 712010.
Open, Classified		 IZLK233678
Oct 23, 2026ZIEHM-ORTHOSCAN INC
Orthoscan VERSA Accessory Cart, REF: 1000-0021 and Versa Mini C-Arm System, REF: 1000-0020
Open, Classified		 OXOK243452
Oct 23, 2026Medtronic, Inc.
OmniaSecure Model 3930M, LEAD 3930M74 74 CM DF4 MR 3930M74 LEAD 3930M79 79 CM DF4 MR 3930M79 The Medtronic OmniaSecure" Model 3930M lead is a steroid eluting, integrated bipolar, nonretractable scr
Open, Classified		 NVYNone listed
Oct 23, 2026Ethicon, LLC
ETHILON Nylon Suture, Product Code 697G
Open, Classified		 GAQK946173
Oct 22, 2026AVID Medical, Inc.
Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH30.
Open, Classified		 LRONone listed
Oct 22, 2026AVID Medical, Inc.
Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH31.
Open, Classified		 LRONone listed
Oct 22, 2026Medline Industries, LP
MEDLINE medical convenience kits labeled as: 1) HIP SCOPE PACK, Medline Kit Number/SKU DYNJ64103C; 2) HIP SCOPE PACK, Medline Kit Number/SKU DYNJ64155B.
Open, Classified		 PUINone listed
Oct 22, 2026Medline Industries, LP
MEDLINE medical convenience kits labeled as: C-SECTION TRAY-LF, Medline Kit Number/SKU OBN471K
Open, Classified		 PUINone listed
Oct 22, 2026Medline Industries, LP
MEDLINE medical convenience kits labeled as: TUBAL LIGATION RFD, Medline Product Number/SKU DYNJ906291G
Open, Classified		 PUINone listed
Oct 22, 2026Medline Industries, LP
MEDLINE medical convenience kits labeled as: (list truncated)
Open, Classified		 PUINone listed
Oct 22, 2026Medline Industries, LP
MEDLINE medical convenience kits labeled as: 1) LAPAROTOMY GYN CDS, Medline Kit Number/SKU CDS983529O; 2) GYN ROBOTIC PK-LF, Medline Kit Number/SKU DYNJ52432M; 3) TAH PACK, Medline Kit Number/SKU
Open, Classified		 PUINone listed
Oct 22, 2026Medline Industries, LP
MEDLINE medical convenience kits labeled as: 1) BIRTHDAY KIT-DOUBLE BASIN-LF, Medline Kit Number/SKU DYNJ16127N; 2) NYGH-DELIVERY PACK-LF, Medline Kit Number/SKU DYNJ27206D; 3) OB/GYN, Medline Kit
Open, Classified		 PUINone listed
Oct 22, 2026Medline Industries, LP
MEDLINE medical convenience kits labeled as (list truncated)
Open, Classified		 PUINone listed
Oct 22, 2026Medline Industries, LP
MEDLINE medical convenience kits labeled as: 1) FETAL SURGERY CDS-LF, Medline Kit Number/SKUCDS840214R; 2) MAJOR, Medline Kit Number/SKUDYNJ904851I; 3) ABDOMINAL TRANSPLANT, Medline Kit Number/SKUD
Open, Classified		 PUINone listed
Oct 22, 2026Medline Industries, LP
MEDLINE medical convenience kits labeled as: C-SECTION PACK, Medline Product Number/SKU DYNJ48455A
Open, Classified		 PUINone listed
Oct 22, 2026Medline Industries, LP
MEDLINE medical convenience kits labeled as: FETOSCOPY CDS-LF, Medline Product Number/SKU CDS840215P
Open, Classified		 PUINone listed
Oct 22, 2026Medline Industries, LP
MEDLINE DRAPE C-SECTION FEN CLR SCREEN W, Medline Product Number/SKU DYNJP6108
Open, Classified		 PUINone listed
Oct 22, 2026Medline Industries, LP
MEDLINE DRAPE C-SEC FEN CLEAR SCRN WIRE, Medline Product Number/SKU DYNJP6106
Open, Classified		 PUINone listed
Oct 22, 2026Medline Industries, LP
MEDLINE DRAPE C-SECTION W/POUCH ST 7/CS, Medline Product Number/SKU DYNJP6101
Open, Classified		 PUINone listed
Oct 22, 2026Solstice Corporation
Xact mole marker for mammography Model/Catalog Number: M15RM
Open, Classified		 JACNone listed
Oct 22, 2026Medtronic Neuromodulation
InterStim Percutaneous Extensions EXT 3560022 ISTM II PERC 3560022 EXT 3560030 ISTM MICRO PERC 3560030
Open, Classified		 EZWNone listed