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 119 of 1190
FDA device recalls, page 119 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-3085-2024Class IBaxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical...Baxter Healthcare CorporationLHI
Z-3084-2024Class IBaxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a...Baxter Healthcare CorporationLHI
Z-3083-2024Class IBaxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a...Baxter Healthcare CorporationLHI
Z-3082-2024Class IBaxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a...Baxter Healthcare CorporationLHI
Z-0073-2025Class IIStabiliT TOUCH Syringe, REF: IN8VCF/BMerit Medical Systems, Inc.OAR
Z-0072-2025Class IIbasixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C...Merit Medical Systems, Inc.PTM
Z-0071-2025Class IIbasixSKY Inflation Device, REF: SKY1802Merit Medical Systems, Inc.PTM
Z-0070-2025Class IICustom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L...Merit Medical Systems, Inc.OEQ
Z-0069-2025Class IIMONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/BMerit Medical Systems, Inc.DXT
Z-0068-2025Class IIBlueFIRE Inflation Device, REF: IN10140Merit Medical Systems, Inc.PTM
Z-0067-2025Class IIIntelliSystem Inflation Device, REF: IN1525/DMerit Medical Systems, Inc.DXT
Z-0066-2025Class IIDiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/AMerit Medical Systems, Inc.DXT
Z-0065-2025Class IIbasixTOUCH Inflation Device, REF: IN8140/AMerit Medical Systems, Inc.PTM
Z-0064-2025Class IIBlue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C...Merit Medical Systems, Inc.DXT
Z-3248-2024Class IISelenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions...Hologic, Inc.OTE
Z-0031-2025Class IIAligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC...Windstone Medical Packaging, Inc.LRO
Z-0030-2025Class IIAligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump...Windstone Medical Packaging, Inc.LRO
Z-0029-2025Class IIAligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC...Windstone Medical Packaging, Inc.OGR
Z-0028-2025Class IIAligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump...Windstone Medical Packaging, Inc.LRO
Z-0027-2025Class IIAligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC...Windstone Medical Packaging, Inc.LRO
Z-3217-2024Class IIACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ACUSON Maple...Siemens Medical Solutions USA, Inc.IYN
Z-3216-2024Class IIACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with softwareSiemens Medical Solutions USA, Inc.IYN
Z-3215-2024Class IIACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with...Siemens Medical Solutions USA, Inc.IYN
Z-3187-2024Class IICreatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test...Roche Diagnostics GmbHJHS
Z-3170-2024Class IIADVIA Chemistry Microalbumin_2 (ALB_2) -For in vitro diagnostic use in the quantitative...Siemens Healthcare Diagnostics Inc.JIR
Z-3169-2024Class IIAtellica CH Microalbumin_2 (ALB_2)-For in vitro diagnostic use in the quantitative...Siemens Healthcare Diagnostics Inc.JIR
Z-3179-2024Class IISTREAMLINE BLOODLINE SET FOR DIALOG DR-Tubing to be used to transfer blood between a...B Braun Medical IncFJK
Z-3178-2024Class IISTREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood between a patient...B Braun Medical IncFJK
Z-3177-2024Class IISTREAMLINE LONG-Tubing to be used to transfer blood between a patient and a haemodialyser...B Braun Medical IncFJK
Z-3176-2024Class IISTREAMLINE BLOODLINE LONG VERSION, FMC-Tubing to be used to transfer blood between a...B Braun Medical IncFJK
Z-3175-2024Class IISTREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and...B Braun Medical IncFJK
Z-3174-2024Class IISTREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and...B Braun Medical IncFJK
Z-3173-2024Class IISL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient...B Braun Medical IncFJK
Z-3142-2024Class IIAlaris Pump Module Model 8100, a modular infusion pump and monitoring systemCareFusion 303, IncFRN
Z-3141-2024Class IIAlaris Syringe Module Model 8110, a modular infusion pump and monitoring systemCareFusion 303, IncFRN
Z-3140-2024Class IIAlaris EtCO2 Module Model 8300, a modular infusion pump and monitoring systemCareFusion 303, IncFRN
Z-3139-2024Class IIAlaris PCA Module Model 8120, a modular infusion pump and monitoring systemCareFusion 303, IncFRN
Z-3138-2024Class IIAlaris System PC Unit Model 8015 - a modular infusion pump and monitoring systemCareFusion 303, IncFRN
Z-0038-2025Class II3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R3M CompanyFRO
Z-3163-2024Class IITxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System...Innovasis, IncMAX
Z-0135-2025Class IISoltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection...OLYMPUS Corporation of the AmericasGEX
Z-0134-2025Class IISoltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation...OLYMPUS Corporation of the AmericasGEX
Z-3099-2024Class IISpacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW...Zoe Medical, Inc.DQA
Z-3098-2024Class IISpacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model...Zoe Medical, Inc.DQA
Z-3191-2024Class IICustom Procedure Kit, REF: K12T-11077Merit Medical Systems, Inc.OEQ
Z-3190-2024Class IIPrelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)Merit Medical Systems, Inc.DRE
Z-0009-2025Class IIBD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet...Becton, Dickinson and Company, BD BiosciencesPER
Z-3097-2024Class IIROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of...Smith & Nephew, Inc.GDW
Z-3096-2024Class IIROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of...Smith & Nephew, Inc.GDW
Z-3143-2024Class IISeer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home...Seer Medical Pty, Ltd.GWQ