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) |
|---|---|---|---|
| Sep 3, 2026 | Fresenius Medical Care Renal Therapies Group, LLC GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis Open, Classified |
KPO | K192209 |
| Sep 2, 2026 | Fresenius Medical Care Renal Therapies Group, LLC 5008X HD/HDF with Twister Blood
Tubing Set
Part Number 03-5350-8 Open, Classified |
KOC | K243505 |
| Sep 2, 2026 | Fresenius Medical Care Renal Therapies Group, LLC 5008X HD/HDF with CLiC Blood
Tubing Set
Part number 03-5300-3C Open, Classified |
KOC | K243505 |
| Sep 2, 2026 | Fresenius Medical Care Renal Therapies Group, LLC 5008X HD/HDF Standard Blood
Tubing Set
Part Number 03-5300-3 Open, Classified |
KOC | K243505 |
| Sep 2, 2026 | Fresenius Medical Care Renal Therapies Group, LLC 5008X Standard HD Pre-Flush
Standard Blood Tubing Set
Part Number 03-5110-6 Open, Classified |
KOC | K243505 |
| Sep 2, 2026 | B Braun Medical Inc Brand Name: Extension Set
Product Name: DISCOFIX FOUR WAY STOPCOCK
Model/Catalog Number: 456025 Open, Classified |
FPA | K942988 |
| Sep 2, 2026 | Boston 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 |
MXD | K231328 |
| Sep 2, 2026 | Boston 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 |
MXD | K231328 |
| Sep 2, 2026 | Boston 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 |
MXD | K231328 |
| Sep 2, 2026 | Medos International Sarl Velys Enabling Tech Robotic-Assist Station
REF: 451611001 Open, Classified |
OLO | K233228 |
| Sep 1, 2026 | Philips 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 |
JAK | K033326 |
| Sep 1, 2026 | Philips 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 |
JAK | K160743 |
| Sep 1, 2026 | Philips North America Llc Philips IQon Spectral CT
Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331
Software 4.7.7.x Open, Classified |
JAK | K193454 |
| Sep 1, 2026 | Philips 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 |
JAK | K250648 |
| Aug 31, 2026 | Medline 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 |
OIB | None listed |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators
ORTHO ASPIRATION KIT
DYKM1636A Open, Classified |
OJH | None listed |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators
CATARACT PREOP KIT
DYKS1583A Open, Classified |
OJK | None listed |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators
C-SECTION PREP
DYNJ32702B Open, Classified |
OHM | None listed |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators
LABOR CDS
CDS981762B
VAG DELIVERY ADMISSION BAG
DYKA1054F Open, Classified |
MLS | None listed |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators
PATIENT ADMIN KIT
DYKA1384B
DYKA1384C
WELCOME KIT
DYKS1206D Open, Classified |
NSB | None listed |
| Aug 31, 2026 | Medline 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 |
OJU | None listed |
| Aug 31, 2026 | Medline 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 |
OIB | None listed |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators
BLOOD CULTURE KIT 2 W/CONNECT
DYNDH1487A Open, Classified |
MCY | None listed |
| Aug 31, 2026 | Medline 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 |
LRS | None listed |
| Aug 31, 2026 | Medline 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 |
LRO | K213481 |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators
BASIN PACK-LF
DYNJ42828B
EYE BASIN TRAY-LF
DYNJ42832B Open, Classified |
KDD | None listed |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators
OPEN HEART
CDS983348AA
CDS983348AB Open, Classified |
OEZ | None listed |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators
PAIN PRE OP KIT
DYKS1476A Open, Classified |
OFT | None listed |
| Aug 31, 2026 | Baxter Healthcare Corporation Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL Open, Classified |
FRN | K242390 |
| Aug 31, 2026 | Baxter Healthcare Corporation Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS Open, Classified |
FRN | K242390 |
| Aug 31, 2026 | Johnson & 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 |
LZP | None listed |
| Aug 31, 2026 | Medline 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 |
OJH | None listed |
| Aug 31, 2026 | Medline 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 |
OJK | None listed |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits:
1) C-SECTION PREP, Model Number: DYNJ32702B Open, Classified |
OHM | None listed |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits:
1) LABOR CDS, Model Number: CDS981762B;
2) VAG DELIVERY ADMISSION BAG, Model Number: DYKA1054F Open, Classified |
MLS | None listed |
| Aug 31, 2026 | Medline 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 |
OJU | None listed |
| Aug 31, 2026 | Medline 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 |
MCY | None listed |
| Aug 31, 2026 | Medline 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 |
LRS | None listed |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits:
1) ARTERIAL LINE INSERTION KIT, Model Number: ART1295 Open, Classified |
LRP | None listed |
| Aug 31, 2026 | Medline 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 |
LRO | K213481 |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits:
1) ULTRASOUND BREAST PACK, Model Number: DYNJ63375C Open, Classified |
FTN | None listed |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits:
1) COLORECTAL ME, Model Number: DYNJ906437D Open, Classified |
FDE | None listed |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits:
1) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920;
2) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920A Open, Classified |
OIB | None listed |
| Aug 31, 2026 | Medline 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 |
OFF | None listed |
| Aug 31, 2026 | Medline 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 |
OEZ | None listed |
| Aug 31, 2026 | Medline 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 |
CAI | None listed |
| Aug 28, 2026 | Diagnostica Stago, Inc. STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074;
qualitative and quantitative factor deficiency test Open, Classified |
GGP | K913424 |
| Aug 28, 2026 | AVID 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 |
OJH | None listed |
| Aug 28, 2026 | AVID 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 |
OJG | None listed |
| Aug 28, 2026 | AVID 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 |
LRO | None listed |