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

59,336 records, page 14 of 1187
FDA device recalls, page 14 of 1187
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2667-2026Class IICK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code...Bard Access Systems, Inc.PND
Z-2666-2026Class II1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code...Bard Access Systems, Inc.LJS
Z-2665-2026Class II7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code...Bard Access Systems, Inc.LJS
Z-2664-2026Class IICK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code...Bard Access Systems, Inc.LJS
Z-2663-2026Class IICK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code...Bard Access Systems, Inc.PND
Z-2662-2026Class IICK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code...Bard Access Systems, Inc.PND
Z-2661-2026Class II5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr...Bard Access Systems, Inc.NIE
Z-2660-2026Class II5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI...Bard Access Systems, Inc.NIE
Z-2659-2026Class II1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110 3173108D PowerPICC...Bard Access Systems, Inc.LJS
Z-2658-2026Class IICK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code...Bard Access Systems, Inc.LJS
Z-2657-2026Class II5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen UDI-DI Code...Bard Access Systems, Inc.PXI
Z-2656-2026Class IICK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code...Bard Access Systems, Inc.PXI
Z-2655-2026Class IIOTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 PIG1260T SAFE-T-CE...Bard Access Systems, Inc.PXI
Z-2626-2026Class IICRE Pro Wireguided 6-8mm 240cmBoston Scientific CorporationFGE
Z-2794-2026Class IIFlexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single...Karl Storz Endoscopy-America, Inc.HIH
Z-2734-2026Class IIPapablic Replacement Brush Heads. Model Number: PAPA317AA.Papablic IncJEQ
Z-2733-2026Class IIPapablic Replacement Brush Heads. Model Number: Papablic18BPapablic IncJEQ
Z-2406-2026Class IIMOSAIQ Oncology Information SystemElekta LimitedIYE
Z-2669-2026Class IISolar GI System (Water Perfusion); Product Name (Catalog Number): Solar GI LGI H2O, 12p...Abbott MedicalFFX
Z-2514-2026Class IIBD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta"...BD Switzerland SARLFMG
Z-2886-2026Class IIBrand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm...United Orthopedic Corp.LXH
Z-2647-2026Class IIRayCare 2024A SP4. Oncology Information Systems.RaySearch Laboratories AB (publ)MUJ
Z-2646-2026Class IIRayCare 2024A SP1. Oncology Information Systems.RaySearch Laboratories AB (publ)MUJ
Z-2643-2026Class IIARTIS icono floor. Model Number: 11327700.Siemens Medical Solutions USA, Inc.OWB
Z-2642-2026Class IIARTIS icono ceiling. Model Number: 11328100.Siemens Medical Solutions USA, Inc.OWB
Z-2641-2026Class IIARTIS icono biplane. Model Number: 11327600.Siemens Medical Solutions USA, Inc.OWB
Z-2531-2026Class IIOff-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number...Zimmer GmbHPHX
Z-2530-2026Class IIOff-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number...Zimmer GmbHPHX
Z-2529-2026Class IIOff-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer...Zimmer GmbHPHX
Z-2528-2026Class IIOff-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer...Zimmer GmbHPHX
Z-2527-2026Class IIOff-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide...Zimmer GmbHPHX
Z-2605-2026Class IOmnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (10 Pack), POD...Insulet CorporationLZG
Z-2604-2026Class IOmnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack)...Insulet CorporationLZG
Z-2603-2026Class IOmnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2...Insulet CorporationQFG
Z-2885-2026Class IIBrand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and...United Orthopedic Corp.LXH
Z-2884-2026Class IIBrand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and Hinge Box...United Orthopedic Corp.KRO
Z-2883-2026Class IIBrand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial...United Orthopedic Corp.JWH
Z-2990-2026Class IIAmerican Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR...American Contract Systems, Inc.OJH
Z-2989-2026Class IIAmerican Contract Systems medical procedure kits and trays labeled as: 1) CRANI PACK...American Contract Systems, Inc.OJG
Z-3046-2026Class IIHalyard medical convenience kits labeled as: 1) A-P PACK - 205936, Model/Item Number...Avid Medical, Inc. a Medical Action Ind. Company 305OJH
Z-3045-2026Class II1) NEURO, (kit) ACNE73-01; 2) NEURO, (kit) ACNE73-03; 3) CRANI, (kit) AKCR19-01; 4)...Avid Medical, Inc. a Medical Action Ind. Company 305OJG
Z-3044-2026Class IIHalyard medical convenience kits labeled as: 1) ENT, Model/Item Number (kit) ACEN89-01...Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-2772-2026Class IIHalyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.Avid Medical, Inc. a Medical Action Ind. Company 305OES
Z-2617-2026Class IIDepuy Synthes, ATTUNE Revision Hinge Knee Hinge Insert Components with the below product...Depuy (Ireland)KRO
Z-2672-2026Class IIGORE TAG Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by...W. L. Gore & Associates, Inc.MIH
Z-2462-2026Class IITRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.Howmedica Osteonics CorpMBH
Z-2461-2026Class IITRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.Howmedica Osteonics CorpMBH
Z-2616-2026Class IIDepuy Synthes, ATTUNE Revision Hinge Knee Hinge Housing Components with the below product...Depuy (Ireland)KRO
Z-2451-2026Class IIMedtronic O-arm O2 Imaging System. Model Number: BI70002000.Medtronic Navigation, IncOWB
Z-2937-2026Class IIProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.Bioporto Diagnostics A/SPIG