Aug 26, 2026
Z-2990-2026
American Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR CERVICAL PACK - 205988, Model Item Number MHAC65AH; 2) SPINE PACK - 206013,…
American Contract Systems Inc
- OJH
- 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
Aug 26, 2026
Z-2989-2026
American Contract Systems medical procedure kits and trays labeled as: 1) CRANI PACK - 208400, Model Item Number UDCP57AI; 2) SPINE PACK, Model Item Number HSL…
American Contract Systems Inc
- OJG
- Class II
- Ongoing
Aug 26, 2026
Z-2987-2026
Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate Model/Catalog Number: 1500-1030; 1500-1035 Software Versio…
restor3d Inc.
- PHX
- Class II
- Ongoing
Aug 26, 2026
Z-2986-2026
Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710, 423712, 423713, 423714, 423715, 423716, 4…
ConvaTec, Inc
- EXG
- Class II
- Ongoing
Aug 26, 2026
Z-2983-2026
Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131
Fort Defiance Industries, LLC
- FLE
- Class II
- Ongoing
Aug 26, 2026
Z-2982-2026
MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW
Medtronic MiniMed, Inc.
- QFG
- Class II
- Ongoing
Aug 26, 2026
Z-2981-2026
MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
Medtronic MiniMed, Inc.
- OZP
- Class II
- Ongoing
Aug 26, 2026
Z-2980-2026
MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;
Medtronic MiniMed, Inc.
- QFG
- Class II
- Ongoing
Aug 26, 2026
Z-2979-2026
BMC/REACTHEALTH Luna G3 APAP REF LG 3600
BMC Medical Co., Ltd.
- MNS
- Class I
- Ongoing
Aug 26, 2026
Z-2978-2026
Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter
Boston Scientific Corporation
- NTE
- Class I
- Ongoing
Aug 26, 2026
Z-2977-2026
Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter
Boston Scientific Corporation
- NTE
- Class I
- Ongoing
Aug 26, 2026
Z-2976-2026
Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL
Siemens Healthcare Diagnostics, Inc.
- LBZ
- Class II
- Ongoing
Aug 26, 2026
Z-2975-2026
Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
Siemens Healthcare Diagnostics, Inc.
- LBZ
- Class II
- Ongoing
Aug 26, 2026
Z-2974-2026
Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Number C63519; 2) AU w/ISE, Part Number C63520;…
Beckman Coulter Inc.
- JJE
- Class II
- Ongoing
Aug 26, 2026
Z-2973-2026
Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522; 2) DxC 500 AU…
Beckman Coulter Inc.
- JJE
- Class II
- Ongoing
Aug 26, 2026
Z-2972-2026
Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant
Paragon 28, Inc.
- Class III
- Ongoing
Aug 26, 2026
Z-2971-2026
Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant
Paragon 28, Inc.
- Class III
- Ongoing
Aug 26, 2026
Z-2970-2026
Blanketrol III, Model 233; Thermal regulating system.
Gentherm Medical, LLC
- Class II
- Ongoing
Aug 26, 2026
Z-2969-2026
Innercool Coolblue Console, Model STx; Thermal regulating system.
Gentherm Medical, LLC
- Class II
- Ongoing
Aug 26, 2026
Z-2968-2026
Blanketrol II Model 222S; Thermal regulating system.
Gentherm Medical, LLC
- Class II
- Ongoing
Aug 26, 2026
Z-2967-2026
Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001
Paragonix Technologies Inc.
- Class II
- Ongoing
Aug 26, 2026
Z-2966-2026
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly
Siemens Healthcare Diagnostics Products Ltd.
- Class II
- Ongoing
Aug 26, 2026
Z-2965-2026
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly
Siemens Healthcare Diagnostics Products Ltd.
- Class II
- Ongoing
Aug 26, 2026
Z-2964-2026
Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907).
AVID Medical, Inc.
- Class II
- Ongoing
Aug 26, 2026
Z-2963-2026
GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; part of the SERVO-U/-N continuous ventilator system, for facility use. Maquet Critical Care AB…
Maquet Critical Care AB
- Class II
- Ongoing