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 127 of 1190
FDA device recalls, page 127 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0144-2025Class IIsmiths medical portex, 15mm Double Swivel Connector: a) REF 100/255/150; b) REF...Abbott MedicalBZA
Z-0143-2025Class IIsmiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY...Abbott MedicalBTQ
Z-3213-2024Class IIprodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5Centinel Spine, LLCMJO
Z-3212-2024Class IIprodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number...Centinel Spine, LLCMJO
Z-2686-2024Class IIBD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of...Becton Dickinson & CoMJA
Z-3156-2024Class IIMazor X. Model Number REF TPL0059; stereotaxic orthopedic instrumentMazor Robotics LtdOLO
Z-2980-2024Class IIPE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.Beckman Coulter Biomedical GmbHCDD
Z-2979-2024Class IIPE Centrifuge, REF: B36365, a component of the Power ExpressBeckman Coulter Biomedical GmbHCDD
Z-2978-2024Class IIPower Express, REF B90918Beckman Coulter Biomedical GmbHCDD
Z-2617-2024Class IIWAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG...Boston Scientific Neuromodulation CorporationLGW
Z-2582-2024Class IISpectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the...Baxter Healthcare CorporationFRN
Z-2581-2024Class IIBaxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of...Baxter Healthcare CorporationFRN
Z-0222-2025Class ICADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a...Abbott MedicalFRN
Z-0093-2025Class IIIBeckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211...Siemens Healthcare Diagnostics Inc.JJW
Z-2944-2024Class ITrilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo...Respironics, Inc.NOU
Z-2943-2024Class ITrilogy Evo Universal Ventilator, Model No. DS2000X11BRespironics, Inc.CBK
Z-2942-2024Class ITrilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux...Respironics, Inc.NOU
Z-2557-2025Class IITiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers...Omnia MedicalOVD
Z-2556-2025Class IITiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30...Omnia MedicalOVD
Z-2534-2024Class IIPhilips Azurion Interventional Fluoroscopic X-ray System with Software Version...Philips Medical Systems Nederland B.V.OWB
Z-2680-2024Class IIProduct Name: 25+TTLPL VPK 20000CPM BEV VAL Model/Catalog Number: 8065753106 Software...Alcon LaboratoriesHQC
Z-2679-2024Class IIProduct Name: 25+ CMB PAK 10K CPM,V,WA 0.9 Model/Catalog Number: 8065752451 Software...Alcon LaboratoriesHQC
Z-2678-2024Class IIProduct Name: 25+ CMB PAK 10K CPM,V,STD 0.9 Model/Catalog Number: 8065752450 Software...Alcon LaboratoriesHQC
Z-2677-2024Class IIProduct Name: TOTAL PLUS,25+,10K VALVE WD Model/Catalog Number: 8065752438 Software...Alcon LaboratoriesHQC
Z-2676-2024Class IIProduct Name: TOTAL PLUS,25+,10K VALVE STD Model/Catalog Number: 8065752437 Software...Alcon LaboratoriesHQC
Z-2675-2024Class IIProduct Name: 25+ CMB PAK 7.5CPM,V,STD 0.9 Model/Catalog Number: 8065751767 Software...Alcon LaboratoriesHQC
Z-2674-2024Class IIProduct Name: TOTALPLUS,25+ 7.5CPM VALV WD6 Model/Catalog Number: 8065751618 Software...Alcon LaboratoriesHQC
Z-2673-2024Class IIProduct Name: TOTAL PLUS,25+ 7.5CPM VALVE Model/Catalog Number: 8065751617 Software...Alcon LaboratoriesHQC
Z-2672-2024Class IIProduct Name: 25+ TOTALPLUSr CP PAK 20K CPM BWV .9 IU Model/Catalog Number...Alcon LaboratoriesHQC
Z-2671-2024Class IIProduct Name: 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU Model/Catalog Number...Alcon LaboratoriesHQC
Z-2670-2024Class IIProduct Desc: Product Name: CLEARCUT SLIT FULL HANDLE3.0MM ANG DUAL Model/Catalog Number...Alcon LaboratoriesHNN
Z-2669-2024Class IIProduct Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE3.0MM ANG Model/Catalog Number...Alcon LaboratoriesHNN
Z-2668-2024Class IIProduct Desc: Product Name: A-OK SATINSLIT FULL HANDLE2.75MM ANG SG Model/Catalog Number...Alcon LaboratoriesHNN
Z-2667-2024Class IIProduct Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.75MM ANG DUA Model/Catalog Number...Alcon LaboratoriesHNN
Z-2666-2024Class IIProduct Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE2.75MM AN Model/Catalog Number...Alcon LaboratoriesHNN
Z-2665-2024Class IIProduct Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.6MM ANG DUAL Model/Catalog Number...Alcon LaboratoriesHNN
Z-2664-2024Class IIProduct Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number...Alcon LaboratoriesHNN
Z-2663-2024Class IIProduct Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number...Alcon LaboratoriesHNN
Z-2662-2024Class IIProduct Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number...Alcon LaboratoriesHNN
Z-2661-2024Class IIProduct Desc: Product Name: A-OK SATINCRESCENT FULL HANDLE2.3MM ANG Model/Catalog Number...Alcon LaboratoriesHNN
Z-2660-2024Class IIProduct Desc: Product Name: CLEARCUT HP2 DB SLIT 3.2MM ANGCE Model/Catalog Number...Alcon LaboratoriesHNN
Z-2659-2024Class IIProduct Desc: Product Name: CLEARCUT HP2 DB SLIT 3.0MM ANGCE Model/Catalog Number...Alcon LaboratoriesHNN
Z-2658-2024Class IIProduct Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog...Alcon LaboratoriesHNN
Z-2657-2024Class IIProduct Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog...Alcon LaboratoriesHNN
Z-2656-2024Class IIProduct Desc: Product Name: 20 Gauge V-Lance Knife Model/Catalog Number...Alcon LaboratoriesHNN
Z-2655-2024Class IIProduct Desc: Product Name: A-OK 19G V-LANCE FULL HANDLE1.6MM SATIN Model/Catalog Number...Alcon LaboratoriesHNN
Z-2654-2024Class IIProduct Desc: Product Name: CLEARCUT SAFETY SLIT SB,2.75MMANG Model/Catalog Number...Alcon LaboratoriesHNN
Z-2653-2024Class IIProduct Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.4 Model/Catalog Number...Alcon LaboratoriesHNN
Z-2652-2024Class IIProduct Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.4 Model/Catalog Number...Alcon LaboratoriesHNN
Z-2651-2024Class IIProduct Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.2 Model/Catalog Number...Alcon LaboratoriesHNN