510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of , the FDA export date. FDA medical device recall database

59,460 records, page 84 of 1190
FDA device recalls, page 84 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1756-2025Class IBard Blakemore Esophageal-Nasogastric Tube (Adult) REF: 0092100C.R. Bard IncKNT
Z-1755-2025Class IBard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. (6mm...C.R. Bard IncKNT
Z-1903-2025Class IIVERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use...Luminex CorporationPEN
Z-1666-2025Class IITempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without...Remote Diagnostic Technologies Ltd.MHX
Z-1729-2025Class IIPhilips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R...Remote Diagnostic Technologies Ltd.MHX
Z-1822-2025Class IIADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.Siemens Healthcare Diagnostics Inc.JIS
Z-1821-2025Class IIAtellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498Siemens Healthcare Diagnostics Inc.JIS
Z-1861-2025Class IIPlus Initial Drill, Article Number: 103.170;Straumann USA, LLCDZA
Z-1876-2025Class IIVITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides...Ortho-Clinical Diagnostics, Inc.DCK
Z-1856-2025Class IIGlidewell HT Implant Twist Drill 1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code...Prismatik Dentalcraft, Inc.NDP
Z-1761-2025Class IIAugmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision...Augmedics Ltd.OLO
Z-1963-2025Class IIMicrotek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI...Microtek Medical LLCPUI
Z-1752-2025Class IIPruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.LeMaitre Vascular Inc.DQT
Z-1751-2025Class IIPruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36...LeMaitre Vascular Inc.DYG
Z-1750-2025Class IITufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38...LeMaitre Vascular Inc.DXE
Z-1727-2025Class IiGo2 DC Car Adapter to be used with iGo2 Portable Oxygen Concentrator Systems. Power cord...Medical Depot Inc.CAW
Z-1760-2025Class ICenterline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate...Centerline BiomedicalDQK
Z-1717-2025Class ICODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial...Integra LifeSciences CorporationHBF
Z-1716-2025Class ICODMAN Disposable Perforator, 14mm. Cranial perforator.Integra LifeSciences CorporationHBF
Z-1730-2025Class IMedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X...Nipro Renal Solutions USA, CorporationKPO
Z-2483-2025Class I3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 243703M CompanyBSB
Z-1698-2025Class IBrand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog...Jaeger Medical GmbHBZE
Z-1697-2025Class IBrand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog...Jaeger Medical GmbHBZE
Z-1738-2025Class IIBlueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for...Tornier S.A.S.PHX
Z-1662-2025Class ICADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to...Abbott MedicalMEA
Z-1682-2025Class ICADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120...Abbott MedicalFRN
Z-1681-2025Class ICADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH...Abbott MedicalMEA
Z-1668-2025Class ICADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 2...Abbott MedicalFRN
Z-1667-2025Class ICADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402...Abbott MedicalMEA
Z-1764-2025Class IICMS8000 Patient MonitorContec Medical Systems Co., Ltd.MHX
Z-1766-2025Class IICenturion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395MEDLINE INDUSTRIES, LP - NorthfieldKDC
Z-1765-2025Class IICenturion Sterile Weitlaner Retractor, Reorder: 67315MEDLINE INDUSTRIES, LP - NorthfieldGAD
Z-1753-2025Class IIPiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic...Richard Wolf GmbHISA
Z-1747-2025Class IIFoundationOne Companion Diagnostic (F1CDx)Foundation Medicine, Inc.PQP
Z-2028-2025Class IIREMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488...Siemens Healthcare Diagnostics Inc.JQP
Z-1728-2025Class IIArtix MT Thrombectomy Device, REF: 32-102Inari Medical, Inc.QEW
Z-2150-2025Class IIMolding Equipment. WCM series. Model WCM-330GL-iApic Yamada AmericaRHK
Z-1722-2025Class IIMicrostream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub...Philips North America LLCCCK
Z-1723-2025Class IIAmbu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000USAmbu Inc.EOQ
Z-1718-2025Class IIBio 1 Granules for Filling 1 mm (2 cm), REF:P822692243, Material: BIOSORB (BTCP 95%...Science & Bio Materials, S.B.M. SASMQV
Z-1726-2025Class IWelch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A...Baxter Healthcare CorporationCBK
Z-1725-2025Class IWelch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2) BT-20-0002A...Baxter Healthcare CorporationCBK
Z-1740-2025Class IIIntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.Philips Medical Systems Nederland B.V.LLZ
Z-1724-2025Class IIINSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.Integra LifeSciences CorporationKTI
Z-1769-2025Class IIKliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examination...Klinika Medical GmbHFMH
Z-1768-2025Class IIKliniTray. KlinioTray. Tissue resection margin examination board/small. Model Number...Klinika Medical GmbHFMH
Z-1670-2025Class IIBrand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MXU-RV35 Product...Micro-X Ltd.IZL
Z-1669-2025Class IIBrand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71...Micro-X Ltd.IZL
Z-1715-2025Class IIBrand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser...OLYMPUS Corporation of the AmericasGEX
Z-1704-2025Class IIEnhanced Verify Evaluation Handset (CFN HH90130FA)Medtronic NeuromodulationEZW