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 136 of 1190
FDA device recalls, page 136 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2214-2024Class IISoftware version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number...Siemens Healthcare Diagnostics Inc.CHL
Z-2176-2024Class IIThe VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for use in...Maquet Cardiovascular LLCGEI
Z-2175-2024Class IIThe VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1...Maquet Cardiovascular LLCGEI
Z-2134-2024Class IIStimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502B Braun Medical IncBXN
Z-2133-2024Class IIStimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278B Braun Medical IncBXN
Z-2132-2024Class IIStimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260B Braun Medical IncBXN
Z-2131-2024Class IIStimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251.B Braun Medical IncBXN
Z-2514-2024Class IIBIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE...BioFire Diagnostics, LLCPCH
Z-2369-2024Class IIProclaim 5 Elite Implantable Pulse Generator, REF 3660, Sterile EO, Rx OnlyAbbott MedicalLGW
Z-2368-2024Class IIProclaim 7 Elite Implantable Pulse Generator, REF 3662, Sterile EO, Rx OnlyAbbott MedicalLGW
Z-2423-2024Class IITourniKwik Tourniquet Set (CFN 79012)Medtronic Perfusion SystemsGDJ
Z-2367-2024Class IIAbbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx OnlyAbbott MedicalPMP
Z-2366-2024Class IIAbbott Proclaim Plus 7 Implantable Pulse Generator, REF 3672, Sterile EO, Rx OnlyAbbott MedicalLGW
Z-2365-2024Class IIAbbott Proclaim Plus 5 Implantable Pulse Generator, REF 3671, Sterile EO, Rx OnlyAbbott MedicalLGW
Z-2364-2024Class IIAbbott Proclaim Plus 5 Implantable Pulse Generator, REF 3670, Sterile EO, Rx OnlyAbbott MedicalLGW
Z-2363-2024Class IIAbbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, Rx OnlyAbbott MedicalLGW
Z-2362-2024Class IIAbbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx OnlyAbbott MedicalLGW
Z-2361-2024Class IIAbbott Proclaim 7 Implantable Pulse Generator, REF 3663, Sterile EO, Rx OnlyAbbott MedicalLGW
Z-2360-2024Class IIAbbott Proclaim XR 7 Implantable Pulse Generator, REF 3662, Sterile EO, Rx OnlyAbbott MedicalLGW
Z-2359-2024Class IIAbbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx OnlyAbbott MedicalLGW
Z-2358-2024Class IIAbbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx OnlyAbbott MedicalLGW
Z-2265-2024Class IIAbbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLYAbbott MedicalMHY
Z-2141-2024Class IIUS AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for...Fresenius Medical Care Renal Therapies Group, LLCFIP
Z-1897-2024Class IIPhilips Allura Xper FD20 Biplane system with an ADN7NT patient table. Model Number...Philips Medical Systems Nederland B.V.OWB
Z-1896-2024Class IIPhilips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010...Philips Medical Systems Nederland B.V.OWB
Z-2159-2024Class IInspire Model 3028, IV Implantable Pulse GeneratorInspire Medical Systems IncMNQ
Z-1895-2024Class IIPhilips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012...Philips Medical Systems Nederland B.V.OWB
Z-2882-2026Class IIHappiest Baby, Inc Pre-loved SNOO Smart Sleeper Model:S1000Happiest Baby, IncQTG
Z-2427-2024Class IIA610 Clinician Programmer (CP) Software Application (app) with the following versions...Medtronic NeuromodulationMHY
Z-2312-2024Class IIKNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: WEKA15BAmerican Contract Systems, Inc.OJH
Z-2311-2024Class IIHAND PACK-Procedure Kit Catalog Number: WEHD16CAmerican Contract Systems, Inc.OJH
Z-2310-2024Class IIHAND PACK-Procedure Kit Catalog Number: WEHD16BAmerican Contract Systems, Inc.OJH
Z-2309-2024Class IIORIF HIP - IM RODDING FEMUR-Procedure Kit Catalog Number: UTHP44SAmerican Contract Systems, Inc.OJH
Z-2308-2024Class IICUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AGAmerican Contract Systems, Inc.OJH
Z-2307-2024Class IICUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AEAmerican Contract Systems, Inc.OJH
Z-2306-2024Class IIACL PACK - 206039-Procedure Kit Catalog Number: UDAC66AAAmerican Contract Systems, Inc.OJH
Z-2305-2024Class IITPK ANTERIOR HIP PACK 176483-Procedure Kit Catalog Number: TPAH21EAmerican Contract Systems, Inc.OJH
Z-2304-2024Class IIARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22VAmerican Contract Systems, Inc.OJH
Z-2303-2024Class IIARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22UAmerican Contract Systems, Inc.OJH
Z-2302-2024Class IITOTAL KNEE-Procedure Kit Catalog Number: SMTK21CAmerican Contract Systems, Inc.OJH
Z-2301-2024Class IIKNEE ARTHROSCOPY-Procedure Kit Catalog Number: SLAR14GAmerican Contract Systems, Inc.OJH
Z-2300-2024Class IIHAND DRAPING SJH-Procedure Kit Catalog Number: SJHD67FAmerican Contract Systems, Inc.OJH
Z-2299-2024Class IITOTAL KNEE-Procedure Kit Catalog Number: SFTK54BAmerican Contract Systems, Inc.OJH
Z-2298-2024Class IIKNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: SFAR60AAmerican Contract Systems, Inc.OJH
Z-2297-2024Class IITOTAL KNEE - 297835 -Procedure Kit Catalog Number: RGTK10LAmerican Contract Systems, Inc.OJH
Z-2296-2024Class IITOTAL KNEE - 297835-Procedure Kit Catalog Number: RGTK10KAmerican Contract Systems, Inc.OJH
Z-2295-2024Class IIHAND PACK 297829--Procedure Kit Catalog Number: RGHN04IAmerican Contract Systems, Inc.OJH
Z-2294-2024Class IITOTAL KNEE -Procedure Kit Catalog Number: QPTK95BAmerican Contract Systems, Inc.OJH
Z-2293-2024Class IITOTAL KNEE -Procedure Kit Catalog Number: QPTK95AAmerican Contract Systems, Inc.OJH
Z-2292-2024Class IIKNEE ARTHROSCOPY-Procedure Kit Catalog Number: QPKA35AAmerican Contract Systems, Inc.OJH