510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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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 163 of 1190
FDA device recalls, page 163 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1020-2024Class IIBD BBL Sensi Disc Cefotaxime - 30 ug, used for semi-quantitative in vitro susceptibility...Becton Dickinson & CoJTN
Z-1019-2024Class IIBD BBL Sensi Disc Cefixime - 5 ug, used for semi-quantitative in vitro susceptibility...Becton Dickinson & CoJTN
Z-1018-2024Class IIBD BBL Sensi Disc Cefepime - 30 ug, used for semi-quantitative in vitro susceptibility...Becton Dickinson & CoJTN
Z-1017-2024Class IIBD BBL Sensi Disc Cefaclor - 30 ug, used for semi-quantitative in vitro susceptibility...Becton Dickinson & CoJTN
Z-1016-2024Class IIBD BBL Sensi Disc Aztreonam - 30 ug, used for semi-quantitative in vitro susceptibility...Becton Dickinson & CoJTN
Z-1015-2024Class IIBD BBL Sensi Disc Azithromycin -15 g, Catalog Number 231682used for semi-quantitative in...Becton Dickinson & CoJTN
Z-1014-2024Class IIBD BBL Sensi Disc Augmentin - 3g, Catalog Number 291270used for semi-quantitative in...Becton Dickinson & CoJTN
Z-1013-2024Class IIBD BBL Sensi Disc Ampicillin with Sulbactam 10/10 g, Catalog Number 231660. Used for...Becton Dickinson & CoJTN
Z-1012-2024Class IIBD BBL Sensi Disc Ampicillin - 10 g, Catalog No. 230705 and 231264; 2 g, Catalog No...Becton Dickinson & CoJTN
Z-1011-2024Class IISensi Disc Amoxicillin with Clavulanic Acid 20/10 g, Catalog No. 231628 and...Becton Dickinson & CoJTN
Z-1075-2024Class IIMicrobiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.Microbiologics, Inc.OHQ
Z-1481-2024Class IIHemostasis Probe, Model: CD-B622LAOLYMPUS Corporation of the AmericasKNS
Z-1173-2024Class IIOPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and LiteImpulse Dynamics USA IncQFV
Z-1157-2024Class IIMedline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringeMEDLINE INDUSTRIES, LP - NorthfieldKYZ
Z-1115-2025Class IIBeckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro...Siemens Healthcare Diagnostics Inc.JJE
Z-1217-2024Class IIUSTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference...United Orthopedic Corp.KRO
Z-1216-2024Class IIUSTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference...United Orthopedic Corp.KRO
Z-1215-2024Class IIUSTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following...United Orthopedic Corp.KRO
Z-1172-2024Class IISynapse CV 6. with AR. A web-based application as the primary user interface for the...FUJIFILM Healthcare Americas CorporationLLZ
Z-1171-2024Class IISynapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary...FUJIFILM Healthcare Americas CorporationLLZ
Z-0956-2024Class IISmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129.Philips North America LLCLNI
Z-0955-2024Class IISmartPath to dStream for 1.5T. Model (REF) Numbers 781260, 782112.Philips North America LLCLNI
Z-0954-2024Class IIIntera Achieva 1.5T Pulsar. Model (REF) Number 781171.Philips North America LLCLNI
Z-0953-2024Class IIIntera 1.5T Achieva Nova-Dual. Model (REF) Number 781173.Philips North America LLCLNI
Z-0952-2024Class IIIntera 1.5T Achieva Nova. Model (REF) Numbers 781172.Philips North America LLCLNI
Z-0951-2024Class IIIngenia 3.0T CX. Model (REF) Numbers 781271, 782105.Philips North America LLCLNI
Z-0950-2024Class IIIngenia 1.5T CX. Model (REF) Numbers 781262, 781261.Philips North America LLCLNI
Z-0949-2024Class IIAchieva XR. Model (REF) Numbers 781153, 781253.Philips North America LLCLNI
Z-0948-2024Class IIAchieva 3.0T. Model. (REF) Numbers 781277, 781177, 781278, 781344, 781345.Philips North America LLCLNI
Z-0947-2024Class IIAchieva 1.5T Initial system. Model (REF) Numbers 781178.Philips North America LLCLNI
Z-0946-2024Class IIAchieva 1.5T Conversion. Model (REF) Numbers 781346, 781283.Philips North America LLCLNI
Z-0945-2024Class IIAchieva 1.5T. Model (REF) Numbers 781196, 781343, 781296.Philips North America LLCLNI
Z-1086-2024Class IIThe Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich...Ortho-Clinical Diagnostics, Inc.QMN
Z-1042-2024Class IIThe Prestige Coil System is a product family of embolic coils with associated delivery...Balt USA, LLCKRD
Z-1041-2024Class IINeurovascular embolization device. The Optima Coil System is a series specialized coils...Balt USA, LLCHCG
Z-0773-2024Class IIStryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L...TORNIER Inc.PHX
Z-0842-2024Class I1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication...Abbott MedicalDSQ
Z-1078-2024Class II3:1 Dermacarrier, Model Number 00219501300, skin graft carrierZimmer Surgical SAFZW
Z-1145-2024Class IIPhilips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of...Philips Medical Systems Nederland B.V.OWB
Z-1144-2024Class IIPhilips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay...Philips Medical Systems Nederland B.V.OWB
Z-1152-2024Class IIPhilips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of...Philips Medical Systems Nederland B.V.OWB
Z-1151-2024Class IIPhilips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay...Philips Medical Systems Nederland B.V.OWB
Z-1156-2024Class IIPhilips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs...Philips Medical Systems Nederland B.V.OWB
Z-0812-2024Class IIISmartPath to dStream for 1.5T, Model No. 781260, 782112Philips North America LLCLNH
Z-0811-2024Class IIIIntera 1.5T, Model No. 781195Philips North America LLCLNH
Z-0810-2024Class IIIIngenia Ambition X, Model No. 782109Philips North America LLCLNI
Z-0809-2024Class IIIAchieva 3.0T, Model No. 781177Philips North America LLCLNI
Z-0808-2024Class IIIAchieva 1.5T Conversion, Model No. 781283Philips North America LLCLNI
Z-0807-2024Class IIIAchieva 1.5T, Model No. 781178, 781196, 781296Philips North America LLCLNI
Z-0867-2024Class IIMB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE...Aesculap IncHCF