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 23 of 1187
FDA device recalls, page 23 of 1187
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2178-2026Class IIBARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY...Stryker Sustainability SolutionsNLH
Z-2177-2026Class IIBARD Dynamic Tip Steerable, Product Number 6DYNTP001;Stryker Sustainability SolutionsNLH
Z-2176-2026Class IIBARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETERStryker Sustainability SolutionsNLH
Z-2175-2026Class IIBARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETERStryker Sustainability SolutionsNLH
Z-2174-2026Class IIBARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETERStryker Sustainability SolutionsNLH
Z-2166-2026Class IIThermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The...Stryker Corp.HIG
Z-2204-2026Class IISwan-Ganz Pacing Catheter, Models: D200F7;Becton Dickinson & CoDYG
Z-2203-2026Class IISwan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755PBecton Dickinson & CoDYG
Z-2201-2026Class IIMedtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application...Medtronic NeuromodulationLKK
Z-2202-2026Class IISwan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P...Becton Dickinson & CoDYB
Z-2168-2026Class II3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB...Hologic, Inc.OTE
Z-2167-2026Class IISELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC...Hologic, Inc.MUE
Z-1983-2026Class IIBD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic useBecton Dickinson & CoKZJ
Z-1982-2026Class IIBD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic useBecton Dickinson & CoKZJ
Z-2675-2026Class IIThe intended use is to be paired with a weapon for aiming purposes.Wilcox Industries Corp.REU
Z-2200-2026Class IILVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking...Terumo Cardiovascular Systems CorporationQCA
Z-2169-2026Class IIQuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.Ortho-Clinical Diagnostics, Inc.GTY
Z-2552-2026Class IIInzone Detachment System, Ref: M00345100950Stryker Corp.HCG
Z-2308-2026Class IITITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375...Grace Medical, Inc.ETB
Z-1993-2026Class IIDepuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208.Depuy (Ireland)KRO
Z-1992-2026Class IIDepuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450207.Depuy (Ireland)KRO
Z-1991-2026Class IIDepuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205.Depuy (Ireland)KRO
Z-1990-2026Class IIDepuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204.Depuy (Ireland)KRO
Z-1989-2026Class IIDepuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203.Depuy (Ireland)KRO
Z-1988-2026Class IIDepuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.Depuy (Ireland)KRO
Z-1987-2026Class IIDepuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107.Depuy (Ireland)KRO
Z-1986-2026Class IIDepuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105.Depuy (Ireland)KRO
Z-1985-2026Class IIDepuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104.Depuy (Ireland)KRO
Z-2712-2026Class IIBrand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The device...Elekta LimitedJAQ
Z-2711-2026Class IIBrand Name: Brachytherapy Applicator Product Name: Advanced Gynecological...Elekta LimitedJAQ
Z-2710-2026Class IIBrand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote...Elekta LimitedJAQ
Z-2066-2026Class ICustom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes...Windstone Medical Packaging, Inc.LRO
Z-2088-2026Class IIOne Step P in vitro diagnostic test REF: 8194DFI Co., Ltd.JIR
Z-2087-2026Class IIOne Step K in vitro diagnostic test REF: 81A4DFI Co., Ltd.JIN
Z-2086-2026Class IIUric Acid in vitro diagnostic test REF: 31H0PDFI Co., Ltd.KNK
Z-2085-2026Class IIQUCARE Total Cholesterol in vitro diagnostic test REF: 6407DFI Co., Ltd.CHH
Z-2084-2026Class IIOne Step pH in vitro diagnostic test REF: 31I4PDFI Co., Ltd.CEN
Z-2083-2026Class IIOne Step UTI in vitro diagnostic test REF: 3374DFI Co., Ltd.LJX
Z-2082-2026Class IIOne Step 10A in vitro diagnostic testDFI Co., Ltd.MVO
Z-1936-2026Class IBeacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-1...Cook IncorporatedDQO
Z-1935-2026Class IAurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing...Cook IncorporatedDQO
Z-1934-2026Class ICentimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use...Cook IncorporatedDQO
Z-2005-2026Class IIepoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material...Siemens Healthcare Diagnostics Inc.CHL
Z-2004-2026Class IIPhilips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLYMerit Medical Systems, Inc.OEQ
Z-2003-2026Class IIPhilips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLYMerit Medical Systems, Inc.OEQ
Z-2002-2026Class IIPhilips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLYMerit Medical Systems, Inc.OEQ
Z-2046-2026Class IIBrand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical...Intuitive Surgical, Inc.NAY
Z-2171-2026Class IIZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040AAniara Diagnostica LLCLCO
Z-2081-2026Class IIBiofire Spotfire Respiratory/Sore Throat Panel REF: 423485BioFire Diagnostics, LLCQOF
Z-2001-2026Class IIi-STAT G3+ cartridge; List Number: 03P78-26;Abbott MedicalCHL