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 143 of 1190
FDA device recalls, page 143 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1871-2024Class IIIncisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images...Philips North America LLCJAK
Z-1932-2024Class IIBD Pyxis(TM) Anesthesia Station 4000, REF: 338CareFusion 303, IncBRY
Z-1931-2024Class IIBD Pyxis" Anesthesia Station ES, REF: 327CareFusion 303, IncBRY
Z-1930-2024Class IIBD Pyxis MedStation 4000 7-Drawer Auxiliary Tower, REF: 306CareFusion 303, IncBRY
Z-1929-2024Class IIBD Pyxis" MedStation ES 7-Drawer Auxiliary Tower, REF: 324CareFusion 303, IncBRY
Z-1928-2024Class IIBD Pyxis MedStation 4000 System, REF: 303, Medication CabinetCareFusion 303, IncBRY
Z-1927-2024Class IIBD Pyxis MedStation ES, REF: 323, Medication CabinetCareFusion 303, IncBRY
Z-1891-2024Class IITri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in...Medtronic, Inc.GDW
Z-1915-2024Class IITotal Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee...Stryker OrthopaedicsOLO
Z-1914-2024Class IITotal Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee...Stryker OrthopaedicsOLO
Z-1913-2024Class IITotal Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee...Stryker OrthopaedicsOLO
Z-1912-2024Class IITotal Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee...Stryker OrthopaedicsOLO
Z-1911-2024Class IITotal Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee...Stryker OrthopaedicsOLO
Z-1910-2024Class IITotal Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee...Stryker OrthopaedicsOLO
Z-1831-2024Class IICARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.Maquet Cardiovascular Us Sales, LLCDTQ
Z-1821-2024Class IIAPTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the...Medartis AGHWC
Z-1943-2024Class IIArial mobile application, model numbers 54640, 54630, and 54630-SMA, that utilizes Apple...Securitas Healthcare LLCIQA
Z-1898-2024Class IIFDR Visionary Suite - Intended to generate digital or conventional radiographic images of...FUJIFILM Healthcare Americas CorporationKPR
Z-1884-2024Class IINoblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24FUJIFILM Healthcare Americas CorporationIYN
Z-2318-2024Class II9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in...PREAT CorporationNHA
Z-1947-2024Class IILeica HistoCore PEGASUS Tissue Processor, REF 14048858005.Leica Biosystems Nussloch GmbHIEO
Z-2027-2024Class IIGE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ONE-A1-1B...GE Medical Systems Information Technologies, Inc.DXQ
Z-1826-2024Class IIThe Sophysa Pressio Ventricular Intracranial Pressure Monitoring Kit monitoring is...SophysaGWM
Z-1825-2024Class IIThe Sophysa Pressio Ventricular Intracranial Pressure Monitoring Kit monitoring is...SophysaGWM
Z-1810-2024Class IISpectrum IQ Infusion pump, Product Code 357009Baxter Healthcare CorporationFRN
Z-1819-2024Class IIVITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use with Free T3 Reagent...QuidelorthoJIS
Z-1818-2024Class IIVITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantitative...QuidelorthoCDP
Z-2635-2024Class IIMedline Convenience kits, labeled as: 1) NERVE STIMULATOR, Pack Number CDS981579O ; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOGJ
Z-2634-2024Class IIMedline convenience kits, labeled as: 1) PAIN SERVICES CDS , Pack Number CDS985445B...MEDLINE INDUSTRIES, LP - NorthfieldOFT
Z-3061-2024Class IIMedline Convenience kits, labeled as: aa1) BURN PACK-LF, Pack Number DYNJ0781678S...MEDLINE INDUSTRIES, LP - NorthfieldOJJ
Z-3060-2024Class IIMedline Convenience kits, labeled as: 1) KNEE ARTHROSCOPY CDS-LF , Pack Number...MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-3059-2024Class IIMedline Convenience kits, labeled as: 1) BLOOD CULTURE COLLECTION KIT, Pack Number...MEDLINE INDUSTRIES, LP - NorthfieldOIB
Z-3058-2024Class IIMedline Convenience kits, labeled as: BIOPSY TRAY-LF, Pack Number DYNDH1229MEDLINE INDUSTRIES, LP - NorthfieldMJG
Z-3057-2024Class IIMedline Convenience kits, labeled as: GAMMA NAIL CDS-LF , Pack Number CDS983505KMEDLINE INDUSTRIES, LP - NorthfieldMCM
Z-3056-2024Class IIMedline Convenience kits, labeled as: 1) SUTURING SET PACK ASSY P791011, Pack Number...MEDLINE INDUSTRIES, LP - NorthfieldMCZ
Z-3055-2024Class IIMedline Convenience kits, containing Shenli syringes, labeled as: 1) LOCAL PACK, Pack...MEDLINE INDUSTRIES, LP - NorthfieldOFQ
Z-3054-2024Class IIMedline Convenience kits labeled as: 1) ARTHROGRAPHY DRAPE PACK , Pack Number...MEDLINE INDUSTRIES, LP - NorthfieldOII
Z-3053-2024Class IIMedline Convenience kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Code 613034700...MEDLINE INDUSTRIES, LP - NorthfieldHRX
Z-3052-2024Class IIMedline Convenience kits labeled as: 1) SPECIAL PROCEDURE PACK ARTERI , Pack Number...MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-3051-2024Class IIMedline Convenience kits labeled as: 1) ADULT DRAWER 5, Pack Number ACC010647A ; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOJK
Z-3050-2024Class IIMedline Convenience kits labeled as: 1) LABOR & DELIVERY CDS, Pack Number CDS830039AD...MEDLINE INDUSTRIES, LP - NorthfieldOKV
Z-3049-2024Class IIMedline Convenience kits labeled as: 1) OFFICE PACK FOR HYSTEROSCOPY, Pack Number...MEDLINE INDUSTRIES, LP - NorthfieldOJF
Z-3048-2024Class IIMedline Convenience kits labeled as: 1) C-SECTION TRAY, Pack Number AM160B ; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOHM
Z-3047-2024Class IIMedline Convenience kits labeled as: 1) UROLOGY MINOR CDS , Pack Number CDS980371J...MEDLINE INDUSTRIES, LP - NorthfieldOHG
Z-3046-2024Class IIMedline Convenience kits labeled as: 1) LAVH CDS, Pack Number CDS760049AB; 2) TUBAL...MEDLINE INDUSTRIES, LP - NorthfieldOHD
Z-3045-2024Class IIMedline Convenience kits labeled as: 1) GROTH PELVISCOPY CDS, Pack Number CDS984187T...MEDLINE INDUSTRIES, LP - NorthfieldMLT
Z-3044-2024Class IIMedline Convenience kits labeled as: 1) PACK VAGINAL DELIVERY , Pack Number AM185B...MEDLINE INDUSTRIES, LP - NorthfieldMLS
Z-3043-2024Class IIMedline Convenience kits labeled as: HSG TRAY, Pack Number DYNDH1453MEDLINE INDUSTRIES, LP - NorthfieldHGD
Z-3042-2024Class IIMedline Convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number...MEDLINE INDUSTRIES, LP - NorthfieldOJG
Z-3041-2024Class IIMedline Convenience kits labeled as: 1) CHEST TUBE INSERTION TRAY, Pack Number...MEDLINE INDUSTRIES, LP - NorthfieldPWY