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)
Sep 11, 2026ICU Medical, Inc.
IV Sets with drip chambers
Open, Classified
FMGK964435
Sep 11, 2026GE Medical Systems Information Technologies Inc
Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13 Product code STU CSCS V3 MAI800 Integrated Part Number 5867474-03 Product Code STV
Open, Classified
DQKK162012
Sep 11, 2026Given Imaging Ltd.
Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule delivery device, 1-pack, Product Number FGS-0636. Used to attach a pH monitoring capsule to the esophagus.
Open, Classified
FFTNone listed
Sep 11, 2026Philips North America
Philips PIC iX Essentials REF:867093
Open, Classified
MHXK153702
Sep 11, 2026Medline Industries, LP
Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N
Open, Classified
LROK213481
Sep 11, 2026Bard Access Systems, Inc.
DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625150; DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625200; DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625240; DuoGlide Short
Open, Classified
MPBK030268
K090102
Sep 11, 2026Philips North America
Philips Patient Information Center iX REF:866389
Open, Classified
MHXK153702
Sep 11, 2026ICU Medical, Inc.
IV Sets with drip chambers
Open, Classified
FRNK141789
Sep 11, 2026ICU Medical, Inc.
IV Sets with drip chambers
Open, Classified
ONBK131549
K170110 +1
Sep 11, 2026ICU Medical, Inc.
IV Sets with drip chambers
Open, Classified
FPAK081361
K100576 +3
Sep 11, 2026ICU Medical, Inc.
Oncology sets with drip chambers
Open, Classified
ONBK131549
K173477
Sep 11, 2026ICU Medical, Inc.
Oncology sets with drip chambers
Open, Classified
FPAK081361
Sep 11, 2026Nova Biomedical Corporation
StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system.
Open, Classified
PZIK232075
Sep 11, 2026Nova Biomedical Corporation
StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system.
Open, Classified
PZIK232075
Sep 11, 2026ICU Medical, Inc.
IV Non-Dedicated Gravity Administration Sets with drip chambers
Open, Classified
FMGK964435
Sep 11, 2026Bard Access Systems, Inc.
Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605150; Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605200; Power-Trialysis Short-Term Straight Dialysis Catheter, REF:
Open, Classified
MPBK133456
K141531
Sep 11, 2026ICU Medical, Inc.
Plum administration sets
Open, Classified
FPANone listed
Sep 10, 2026Windstone Medical Packaging, Inc.
AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B
Open, Classified
KDDNone listed
Sep 10, 2026Nipro Renal Soultions USA, Corporation
Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)
Open, Classified
KPOK223431
Sep 10, 2026Nipro Renal Soultions USA, Corporation
Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25
Open, Classified
KPOK171750
Sep 10, 2026Nipro Renal Soultions USA, Corporation
MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
Open, Classified
KPOK131202
Sep 10, 2026Nipro Renal Soultions USA, Corporation
MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
Open, Classified
KPOK012547
Sep 9, 2026Medical Action Industries, Inc. 306
Kit: Single Shot Epidural 20/Cs, REF: 59553; Kit: Single Shot Epidural 20/Cs, REF: 83945B. Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules
Open, Classified
OFTNone listed
Sep 9, 2026Medical Action Industries, Inc. 306
Kit: Epidural/Pain TQC 20/Cs, REF: 82465 Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules
Open, Classified
OGJNone listed
Sep 4, 2026Atrium Medical Corporation
Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);
Open, Classified
GBZNone listed
Sep 4, 2026Atrium Medical Corporation
Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case; Size(Model Number): 1. 24FR(8124), 2. 28FR(8128), 3. 32FR(8132), 4. 36FR(8136);
Open, Classified
GBZNone listed
Sep 4, 2026Atrium Medical Corporation
Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4. 32FR(8032), 5. 36FR(8036);
Open, Classified
GBZNone listed
Sep 4, 2026Lutronic Corporation
Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that delivers pulsed laser energy at wavelengths of 532 nm and 1064 nm through a fiber-optic handpiece. The system
Open, Classified
GEXK203788
Sep 4, 2026HeartSine Technologies Ltd
HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Min CPR UDI-DI code: 0506016712207 350P US Device, US English
Open, Classified
MKJNone listed
Sep 4, 2026AVID Medical, Inc.
Halyard IV Start Kit Non-Sterile REF: KRIV26-02
Open, Classified
LRONone listed
Sep 4, 2026C.R. Bard Inc
Products that contain the Pericare Wipes: (Canada Only) SureStep" Foley Tray System Bardex IC Complete Care REF: A300314AC UDI-DI code: 00801741143243 SureStep" Foley Tray System Bardex IC Complete C
Open, Classified
KNXNone listed
Sep 4, 2026C.R. Bard Inc
Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley Catheter REF: A153200 UDI code: 00801741121067 10801741121064 SureStep" Foley Tray System Complete Care Add-A-Foley
Open, Classified
KNXNone listed
Sep 4, 2026C.R. Bard Inc
Products that contain the Pericare Wipes: SureStep Intermittent Catheter Tray REF: INTP16 INTS14 INTS14C INTS16 INTS16C PEDINTS06 PEDINTS08 PEDINTS10 UDI code: 00801741183300 10801741183307 008017411
Open, Classified
KODK000723
K802665
Sep 4, 2026C.R. Bard Inc
Products that contain the Pericare Wipes: *Bardex I.C. Complete Care Foley Catheter Tray REF: 300316A UDI codes: 00801741024344 10801741024341 *Bardex I.C. Complete Care Foley Catheter Tray and Urin
Open, Classified
MJCK040658
K910318 +1
Sep 4, 2026C.R. Bard Inc
Products that contain the Pericare Wipes: Bard Foley Tray With Lubri-Sil All-Silicone Foley Catheter REF: 947314 947316 947318 UDI codes: 00801741024924 10801741024921 00801741024931 10801741024938 0
Open, Classified
EZLK040504
K070508 +2
Sep 4, 2026C.R. Bard Inc
Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF: 899914 899916 899918 UDI codes: 00801741024801 10801741024808 00801741024818 10801741024815 00801741024825 10801741
Open, Classified
EZCK910197
K910846
Sep 3, 2026Cardinal Health 200, LLC
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, CHONY ORTHO MAJOR SPINE , Catalog Number: POV2SCCPP; 2) KIT,ORTHOPLASTIC MICROVASCULAR, Catalog Number:
Open, Classified
OJHNone listed
Sep 3, 2026Cardinal Health 200, LLC
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ASLMC CRANIOTOMY , Catalog Number: PNCGCNAUM; 2) KIT, ORP MAJOR SPINE , Catalog Number:
Open, Classified
OJGNone listed
Sep 3, 2026Cardinal Health 200, LLC
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) PBCGLVBLI, Catalog Number: KIT, BLO LAVH ; 2) PB15HYFCY, Catalog Number: KIT, UMMC AB HYST II
Open, Classified
OJFNone listed
Sep 3, 2026Cardinal Health 200, LLC
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ROBOTIC HYST , Catalog Number: PB41RHRM3; 2) KIT, ROBOTIC HYST , Catalog Number:
Open, Classified
OHMNone listed
Sep 3, 2026Cardinal Health 200, LLC
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, BLO ROBOTIC GYN , Catalog Number: PBCGRGB28; 2) KIT , GYN MAJOR BARNES JEWIS, Catalog Number:
Open, Classified
OHDNone listed
Sep 3, 2026Cardinal Health 200, LLC
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ENT HARVEST , Catalog Number: PEVMETBJX; 2) KIT, ENT HARVEST , Catalog Number:
Open, Classified
OGRNone listed
Sep 3, 2026Cardinal Health 200, LLC
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number: PWV2MF01D
Open, Classified
OFXNone listed
Sep 3, 2026Cardinal Health 200, LLC
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GVI OPEN HEART A B , Catalog Number: PCVNCG540; 2) KIT, GVI OPEN HEART A B , Catalog Number:
Open, Classified
OEZNone listed
Sep 3, 2026Cardinal Health 200, LLC
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,ROBOTICS DH , Catalog Number: PGOCRDNHD; 2) KIT, EAS ROBOTIC , Catalog Number:
Open, Classified
NWUNone listed
Sep 3, 2026Cardinal Health 200, LLC
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, LUNG TX CIRCULATOR , Catalog Number: OVC3507231
Open, Classified
LRPNone listed
Sep 3, 2026Cardinal Health 200, LLC
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GYN ROBOTIC GSAM , Catalog Number: PBCCGRSGD; 2) KIT, GYN ROBOT ACCESSORY , Catalog Number:
Open, Classified
LRONone listed
Sep 3, 2026Cardinal Health 200, LLC
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,GYN LAPAROSCOPY DH , Catalog Number: PBOCGLN17
Open, Classified
FDENone listed
Sep 3, 2026Fresenius Medical Care Renal Therapies Group, LLC
Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA; Liquid Acid Concentrate for Bicarbonate Hemodialysis
Open, Classified
KPOK192017
K212620
Sep 3, 2026Fresenius Medical Care Renal Therapies Group, LLC
NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 13-2201-5, 13-2251-0, 13-3251-9; Liquid Acid Concentrate for
Open, Classified
KPOK192017
K212620