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 3, 2026Fresenius Medical Care Renal Therapies Group, LLC
GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis
Open, Classified
KPOK192209
Sep 2, 2026Fresenius Medical Care Renal Therapies Group, LLC
5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
Open, Classified
KOCK243505
Sep 2, 2026Fresenius Medical Care Renal Therapies Group, LLC
5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
Open, Classified
KOCK243505
Sep 2, 2026Fresenius Medical Care Renal Therapies Group, LLC
5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3
Open, Classified
KOCK243505
Sep 2, 2026Fresenius Medical Care Renal Therapies Group, LLC
5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
Open, Classified
KOCK243505
Sep 2, 2026B Braun Medical Inc
Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025
Open, Classified
FPAK942988
Sep 2, 2026Boston Scientific Corporation
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model Number 7248, All Versions (Current 7.7)
Open, Classified
MXDK231328
Sep 2, 2026Boston Scientific Corporation
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU, Model Number 7246, All Versions (Current 7.7)
Open, Classified
MXDK231328
Sep 2, 2026Boston Scientific Corporation
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Versions (Current 7.8)
Open, Classified
MXDK231328
Sep 2, 2026Medos International Sarl
Velys Enabling Tech Robotic-Assist Station REF: 451611001
Open, Classified
OLOK233228
Sep 1, 2026Philips North America Llc
Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x
Open, Classified
JAKK033326
Sep 1, 2026Philips North America Llc
Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Software 4.4.10.x
Open, Classified
JAKK160743
Sep 1, 2026Philips North America Llc
Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.x
Open, Classified
JAKK193454
Sep 1, 2026Philips North America Llc
Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311.
Open, Classified
JAKK250648
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits: 1) BLOOD DRAW KIT, Catalog Number: DYLAB1081; 2) WHOLE BLOOD PHLEBOTOMY KIT, Catalog Number: DYNDB3005D; 3) QP KIT, Catalog Number: DYNDB3005F; 4) DOUBLE RED CELL PHLEBOTO
Open, Classified
OIBNone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ORTHO ASPIRATION KIT DYKM1636A
Open, Classified
OJHNone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators CATARACT PREOP KIT DYKS1583A
Open, Classified
OJKNone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators C-SECTION PREP DYNJ32702B
Open, Classified
OHMNone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators LABOR CDS CDS981762B VAG DELIVERY ADMISSION BAG DYKA1054F
Open, Classified
MLSNone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PATIENT ADMIN KIT DYKA1384B DYKA1384C WELCOME KIT DYKS1206D
Open, Classified
NSBNone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators DELUXE PRE OP KIT DYKS2018 GENERAL PREOP KIT DYKS1584A PRE OP KIT DYKS1216I PRE-OP KIT DYKM1398B
Open, Classified
OJUNone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ADULT BLOOD CULTURE KIT DYNDH1444D BLOOD CULTR KT DIVRSN DEVICE DYNDH1866 BLOOD CULTURE KIT DYNDH1462B DYNDH1622C D
Open, Classified
OIBNone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE KIT 2 W/CONNECT DYNDH1487A
Open, Classified
MCYNone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators IV START KIT LAB DRAW-SH CDS860014Q IV START KIT DYKM1000B IV START KIT LAB DRAW-SH CDS860014P ULTRASOUND GUIDED PIV
Open, Classified
LRSNone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE PINK PERIPHERAL DYNDV1875 BOTTOM DRAWER ACC010972 DRAWER #4 ACC010479A DRAWER 2 ACC010690
Open, Classified
LROK213481
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BASIN PACK-LF DYNJ42828B EYE BASIN TRAY-LF DYNJ42832B
Open, Classified
KDDNone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators OPEN HEART CDS983348AA CDS983348AB
Open, Classified
OEZNone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PAIN PRE OP KIT DYKS1476A
Open, Classified
OFTNone listed
Aug 31, 2026Baxter Healthcare Corporation
Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL
Open, Classified
FRNK242390
Aug 31, 2026Baxter Healthcare Corporation
Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS
Open, Classified
FRNK242390
Aug 31, 2026Johnson & Johnson Surgical Vision, Inc.
HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 10300016 (US/CAN) HEALON EndoCoat PRO, REF: 10301012 (EU); HEALON DUET PRO II, REF: 10301016 (EU)
Open, Classified
LZPNone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits: 1) ORTHO ASPIRATION KIT, Model Number: DYKM1636A; 2) SHOULD BLOCK KIT, Model Number: DYKM1881A; 3) TRIMA KIT, Model Number: DYNDB3077C
Open, Classified
OJHNone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits: 1) EYE KIT, Model Number: DYKM2751; 2) EYE KIT, Model Number: DYKM2751A; 3) CATARACT PREOP KIT, Model Number: DYKS1583A; 4) CATARACT PREOP KIT, Model Number: DYKS1583B
Open, Classified
OJKNone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits: 1) C-SECTION PREP, Model Number: DYNJ32702B
Open, Classified
OHMNone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits: 1) LABOR CDS, Model Number: CDS981762B; 2) VAG DELIVERY ADMISSION BAG, Model Number: DYKA1054F
Open, Classified
MLSNone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits: 1) PRE-OP KIT, Catalog Number: DYKS1043F; 2) PRE OP KIT, Catalog Number: DYKS1128C; 3) PRE OP KIT, Catalog Number: DYKS1216I; 4) PRE OP KIT, Catalog Number: DYKS1325A; 5)
Open, Classified
OJUNone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYNDH1193; 2) BLOOD CULTURE KIT 2 W/CONNECT, Model Number: DYNDH1487A
Open, Classified
MCYNone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits: 1) IV START KIT LAB DRAW-SH, Model Number: CDS860014P; 2) IV START KIT, Model Number: DYKM1000B; 3) KIT, I V START NSK, Model Number: DYKM2187; 4) KIT, I V START NSK, Mode
Open, Classified
LRSNone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits: 1) ARTERIAL LINE INSERTION KIT, Model Number: ART1295
Open, Classified
LRPNone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits: 1) IV START KIT, Catalog Number: DYNDV2520; 2) PERIPHERAL LAB BLOOD CULTURE KIT, Catalog Number: DYNDH1983A; 3) PEDI EMERGENCY TRAY-PURPLE, Catalog Number: ACC010157C; 4)
Open, Classified
LROK213481
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits: 1) ULTRASOUND BREAST PACK, Model Number: DYNJ63375C
Open, Classified
FTNNone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits: 1) COLORECTAL ME, Model Number: DYNJ906437D
Open, Classified
FDENone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits: 1) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920; 2) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920A
Open, Classified
OIBNone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits: 1) DYKM1414, Catalog Number: DYKM1414; 2) DYKM1414, Catalog Number: DYKM1414; 3) DYNDH1462A, Catalog Number: DYNDH1462A; 4) DYNJ38145F, Catalog Number: DYNJ38145F; 5) DYN
Open, Classified
OFFNone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits: 1) CDS840396X, Catalog Number: CDS840396X; 2) CDS840396Y, Catalog Number: CDS840396Y; 3) CDS983348AA, Catalog Number: CDS983348AA; 4) CDS983348AB, Catalog Number: CDS98334
Open, Classified
OEZNone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY KIT, Model Number: ACC010741; 2) KIT ANESTHESIA L&D A- LINE SET, Model Number: DYKMBNDL199A
Open, Classified
CAINone listed
Aug 28, 2026Diagnostica Stago, Inc.
STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test
Open, Classified
GGPK913424
Aug 28, 2026AVID Medical, Inc.
Halyard medical convenience kits labeled as: 1) A-P PACK - 205936, Model/Item Number (kit) ANAP22-01; 2) POSTERIOR PACK - 205960, Model/Item Number (kit) ANPP15-01; 3) ANEURYSM PACK, Model/Item Nu
Open, Classified
OJHNone listed
Aug 28, 2026AVID Medical, Inc.
1) NEURO, (kit) ACNE73-01; 2) NEURO, (kit) ACNE73-03; 3) CRANI, (kit) AKCR19-01; 4) ORTHO SPINE PACK, (kit) ARMC017; 5) BMHM NEURO PACK, (kit) BMHT016-05; 6) LUMBAR PACK, (kit) BMHT112-03; 7) NE
Open, Classified
OJGNone listed
Aug 28, 2026AVID Medical, Inc.
Halyard medical convenience kits labeled as: 1) ENT, Model/Item Number (kit) ACEN89-01; 2) ENT, Model/Item Number (kit) ACEN89-02; 3) BACK PACK, Model/Item Number (kit) ALBK51-01; 4) DR DERIAN SP
Open, Classified
LRONone listed