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 98 of 1190
FDA device recalls, page 98 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1120-2025Class II(1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS)...CareFusion 303, IncBRY
Z-1119-2025Class II(1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No...CareFusion 303, IncBRY
Z-1113-2025Class IISysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number...Sysmex America, Inc.PER
Z-1039-2025Class IINexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10...Zimmer GmbHJWH
Z-1038-2025Class IINexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14...Zimmer GmbHJWH
Z-1205-2025Class IVARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is...Biosense Webster IncQZI
Z-1177-2025Class IIIrix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X...Xtant Medical Holdings, Inc.OVD
Z-1173-2025Class IIMedline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience kitMEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-1068-2025Class IIBrand Name: SenTiva DUO" Product Name: VNS Therapy SenTiva DUO", Model...LivaNova USA, Inc.LYJ
Z-1067-2025Class IIBrand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog...LivaNova USA, Inc.LYJ
Z-1234-2025Class IISocrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socrates Aspiration...Scientia VascularNRY
Z-1099-2025Class IIBelmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed...Belmont Medical TechnologiesFRN
Z-1112-2025Class IIAccess PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl...Siemens Healthcare Diagnostics Inc.PTF
Z-0922-2025Class IIARTIS One Angiographic X-Ray SystemSiemens Medical Solutions USA, Inc.OWB
Z-1114-2025Class IIBrasseler ESR Rotary/Reciprocating Endodontic File Device...US Endodontics, LLCEKS
Z-1167-2025Class IIAlteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00...Exactech, Inc.LPH
Z-1166-2025Class IINovation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00...Exactech, Inc.OQI
Z-1165-2025Class IIAcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0 LNR G...Exactech, Inc.OQI
Z-0992-2025Class IMedline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE...MEDLINE INDUSTRIES, LP - NorthfieldLRP
Z-0991-2025Class IMedline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT, Item Number...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-1105-2025Class IINeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU GSP30-2R-48-ENU-USL GSP30...Neilmed Pharmaceuticals IncKCJ
Z-1047-2025Class Iregard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee...ROi CPS LLCMLS
Z-1181-2025Class IIAnchorFast Guard, Oral Endotracheal Tube Fastener, REF 9800,Hollister IncorporatedCBH
Z-1180-2025Class IIAnchorFast, Oral Endotracheal Tube Fastener, REF 9799,Hollister IncorporatedCBH
Z-1179-2025Class IIAnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787,Hollister IncorporatedCBH
Z-1178-2025Class IIAnchorFast Guard Select, Oral Endotracheal Tube Fastener, REF 9700,Hollister IncorporatedCBH
Z-1075-2025Class IILev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797Oxoid, Ltd.JTN
Z-1049-2025Class IIMEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-1048-2025Class IICENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; Infusion Catheter with...MEDLINE INDUSTRIES, LP - NorthfieldDYB
Z-0960-2025Class IVDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D...Percussionaire Corp.CBK
Z-1023-2025Class IICyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled...Accuray IncorporatedIYE
Z-1098-2025Class IIETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in USEthicon, IncGAW
Z-1097-2025Class IIPERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is...Ethicon, IncGAW
Z-1096-2025Class IIPROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is...Ethicon, IncGAW
Z-1008-2025Class IIBrand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software...Integrity Implants, Inc.LXH
Z-1117-2025Class IMax Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in...Permobil, ABITI
Z-1116-2025Class IMax Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction...Permobil, ABITI
Z-1037-2025Class IIHOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553570Boston Scientific CorporationKNS
Z-1036-2025Class IIHOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560Boston Scientific CorporationKNS
Z-1035-2025Class IIHOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550Boston Scientific CorporationKNS
Z-1034-2025Class IIHOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540Boston Scientific CorporationKNS
Z-1033-2025Class IIHOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553530Boston Scientific CorporationKNS
Z-1032-2025Class IIHOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553520Boston Scientific CorporationKNS
Z-1031-2025Class IIAXIOS Stent and Delivery System 15mmx10mm UPN: M00553750Boston Scientific CorporationKNS
Z-1030-2025Class IIAXIOS Stent and Delivery System 10mmx10mm UPN: M00553740Boston Scientific CorporationKNS
Z-1029-2025Class IIAXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690Boston Scientific CorporationKNS
Z-1028-2025Class IIAXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680Boston Scientific CorporationKNS
Z-1027-2025Class IIAXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670Boston Scientific CorporationKNS
Z-1026-2025Class IIAXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660Boston Scientific CorporationKNS
Z-1025-2025Class IIAXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650Boston Scientific CorporationKNS