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 101 of 1190
FDA device recalls, page 101 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1015-2025Class IIBrand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock...Trinity Sterile, Inc.OXQ
Z-1014-2025Class IIBrand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm...Trinity Sterile, Inc.OXQ
Z-1013-2025Class IIBrand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL...Trinity Sterile, Inc.OXQ
Z-1012-2025Class IIBrand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL &...Trinity Sterile, Inc.OXQ
Z-0907-2025Class IIPanther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent...Hologic, Inc.NJR
Z-0986-2025Class IISelect Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr)Medtronic Perfusion SystemsDWF
Z-0985-2025Class IIEOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)Medtronic Perfusion SystemsDWF
Z-0984-2025Class IIDLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)Medtronic Perfusion SystemsDWF
Z-0827-2025Class IVISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)Boston Scientific CorporationNKE
Z-0826-2025Class IVALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)Boston Scientific CorporationNKE
Z-0825-2025Class IALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)Boston Scientific CorporationLWP
Z-0824-2025Class IESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model...Boston Scientific CorporationLWP
Z-0823-2025Class IPROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI...Boston Scientific CorporationLWP
Z-0822-2025Class IACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model...Boston Scientific CorporationLWP
Z-0830-2025Class IImpella RP Flex with SmartAssist; Product Number: 1000323;Abiomed, Inc.PYX
Z-0829-2025Class IImpella RP with SmartAssist; Product Number: 0046-0035;Abiomed, Inc.PYX
Z-1073-2025Class IISenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst...LivaNova USA, Inc.LYJ
Z-1072-2025Class IISenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy...LivaNova USA, Inc.LYJ
Z-1121-2025Class IIMicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22...Terumo Cardiovascular Systems CorporationQCA
Z-1141-2025Class IIBiological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item...HF Acquisition Co. LLCFRC
Z-0831-2025Class Inuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal...Nuwellis, Inc.KDI
Z-0836-2025Class IIIdylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in...Biocartis NVOOI
Z-0904-2025Class IIMedtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090...Medtronic, Inc.LIT
Z-0821-2025Class INeo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805...Mercury Medical Enterprises, LLCBTL
Z-0761-2025Class IIEMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706Encore Medical, LPJWH
Z-0712-2025Class IVasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers...Maquet Cardiovascular LLCGEI
Z-0711-2025Class IVasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated...Maquet Cardiovascular LLCGEI
Z-0795-2025Class IJMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5LJiangsu Jumao X-Care Medical Equipment Co., LtdCAW
Z-1111-2025Class IITemporary Titanium AbutmentsDDS LabNHA
Z-0918-2025Class IIPortrait Core Services, a set of software services that enable the communication and...GE HealthcareMWI
Z-0763-2025Class IIvenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004Fresenius Kabi USA, LLCFRN
Z-0902-2025Class IIBrand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN...Quidel OrthoLFM
Z-0769-2025Class IILINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L=...Waldemar Link GmbH & Co. KGLZO
Z-0901-2025Class IIBrand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN...Quidel OrthoLFM
Z-0801-2025Class IIDialyzer Optiflux 160NReFresenius Medical Care Renal Therapies Group, LLCKDI
Z-1022-2025Class IIMedtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE...Medtronic Navigation, IncOLO
Z-1021-2025Class IIDesign Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of...B Braun Medical IncOFT
Z-0702-2025Class IIHillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with...Augustine Temperature Management, LLCDWJ
Z-0701-2025Class IIAugustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller...Augustine Temperature Management, LLCDWJ
Z-0700-2025Class IIAugustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller...Augustine Temperature Management, LLCDWJ
Z-0954-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE OLSEN-HEG NH SMO DEL...Sklar CorporationHXK
Z-0953-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE PROBE W/EYE CS/50...Sklar CorporationHXB
Z-0952-2025Class IIECONO STERILE medical procedure kits labeled as: ECONO STERILE LEMPERT BONE RONG 6.25"...Sklar CorporationHTX
Z-0951-2025Class IIECONO STERILE medical procedure kits labeled as: ECONO STERILE IRIS HOOK QK REL 4MM 9"...Sklar CorporationHNQ
Z-0950-2025Class IIMedical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50...Sklar CorporationHNF
Z-0949-2025Class IIECONO STERILE medical procedure kits labeled as: ECONO STERILE ALFONSO INFANT SPEC STRL...Sklar CorporationHNC
Z-0948-2025Class IIECONO STERILE medical procedure kits labeled as: ECONO STERILE IUD EXTRACTOR DBL HK...Sklar CorporationHHF
Z-0947-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE MINI TISCH 2.3X4.2MM...Sklar CorporationHFB
Z-0946-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM...Sklar CorporationHDQ
Z-0945-2025Class IIECONO STERILE medical procedure kits labeled as: ECONO STERILE KOGAN ENDOCERV SPEC STER...Sklar CorporationHDL