Sep 9, 2026
Z-3091-2026
GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis
Fresenius Medical Care Renal Therapies Group, LLC
- KPO
- Class II
- Ongoing
Device recalls
openFDA device enforcement reports, enriched with the device recall endpoint when a product code or CDRH recall id is available.
779 records
Sep 9, 2026
Z-3089-2026
Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025
B Braun Medical Inc
- FPA
- Class II
- Ongoing
Sep 9, 2026
Z-3088-2026
Velys Enabling Tech Robotic-Assist Station REF: 451611001
Medos International Sarl
- OLO
- Class II
- Ongoing
Sep 9, 2026
Z-3087-2026
5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
Fresenius Medical Care Renal Therapies Group, LLC
- KOC
- Class II
- Ongoing
Sep 9, 2026
Z-3086-2026
5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
Fresenius Medical Care Renal Therapies Group, LLC
- KOC
- Class II
- Ongoing
Sep 9, 2026
Z-3085-2026
5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3
Fresenius Medical Care Renal Therapies Group, LLC
- KOC
- Class II
- Ongoing
Sep 9, 2026
Z-3084-2026
5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
Fresenius Medical Care Renal Therapies Group, LLC
- KOC
- Class II
- Ongoing
Sep 9, 2026
Z-3083-2026
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)
Boston Scientific Corporation
- MXD
- Class II
- Ongoing
Sep 9, 2026
Z-3082-2026
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)
Boston Scientific Corporation
- MXD
- Class II
- Ongoing
Sep 9, 2026
Z-3081-2026
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)
Boston Scientific Corporation
- MXD
- Class II
- Ongoing
Sep 9, 2026
Z-3079-2026
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ORTHO ASPIRATION KIT DYKM1636A
Medline Industries, LP
- OJH
- Class II
- Ongoing
Sep 9, 2026
Z-3078-2026
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators CATARACT PREOP KIT DYKS1583A
Medline Industries, LP
- OJK
- Class II
- Ongoing
Sep 9, 2026
Z-3077-2026
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators C-SECTION PREP DYNJ32702B
Medline Industries, LP
- OHM
- Class II
- Ongoing
Sep 9, 2026
Z-3076-2026
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators LABOR CDS CDS981762B VAG DELIVERY ADMISSION BAG DYKA1054F
Medline Industries, LP
- MLS
- Class II
- Ongoing
Sep 9, 2026
Z-3075-2026
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PATIENT ADMIN KIT DYKA1384B DYKA1384C WELCOME KIT DYKS1206D
Medline Industries, LP
- NSB
- Class II
- Ongoing
Sep 9, 2026
Z-3074-2026
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators DELUXE PRE OP KIT DYKS2018 GENERAL PREOP KIT DYKS1584A PRE OP KIT DYKS1216I PRE-OP KI…
Medline Industries, LP
- OJU
- Class II
- Ongoing
Sep 9, 2026
Z-3073-2026
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ADULT BLOOD CULTURE KIT DYNDH1444D BLOOD CULTR KT DIVRSN DEVICE DYNDH1866 BLOOD CULTU…
Medline Industries, LP
- OIB
- Class II
- Ongoing
Sep 9, 2026
Z-3072-2026
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE KIT 2 W/CONNECT DYNDH1487A
Medline Industries, LP
- MCY
- Class II
- Ongoing
Sep 9, 2026
Z-3071-2026
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 C…
Medline Industries, LP
- LRS
- Class II
- Ongoing
Sep 9, 2026
Z-3070-2026
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE PINK PERIPHERAL DYNDV1875 BOTTOM DRAWER ACC010972 DRAWER #4 ACC010479A…
Medline Industries, LP
- LRO
- Class II
- Ongoing
Sep 9, 2026
Z-3069-2026
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BASIN PACK-LF DYNJ42828B EYE BASIN TRAY-LF DYNJ42832B
Medline Industries, LP
- KDD
- Class II
- Ongoing
Sep 9, 2026
Z-3068-2026
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators OPEN HEART CDS983348AA CDS983348AB
Medline Industries, LP
- OEZ
- Class II
- Ongoing
Sep 9, 2026
Z-3067-2026
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PAIN PRE OP KIT DYKS1476A
Medline Industries, LP
- OFT
- Class II
- Ongoing
Sep 9, 2026
Z-3066-2026
Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL
Baxter Healthcare Corporation
- FRN
- Class II
- Ongoing
Sep 9, 2026
Z-3065-2026
Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS
Baxter Healthcare Corporation
- FRN
- Class II
- Ongoing