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 42 of 1190
FDA device recalls, page 42 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1331-2026Class IIMedline medical convenience kits packaged as: 1) POWERGLIDE DRESSING CHANGE KIT, Kit...MEDLINE INDUSTRIES, LP - NorthfieldMCY
Z-1330-2026Class II1) UNIVERSAL KIT, Kit SKU DT22010B; 2) VAD ACCESS KIT, Kit SKU DT22790C; 3) VAD ACCESS...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-1329-2026Class IIMedline medical convenience kits packaged as: 1) CANCER SERVICE PORT KIT, Kit SKU...MEDLINE INDUSTRIES, LP - NorthfieldOFF
Z-1328-2026Class IIMedline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG, Kit SKU...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-1327-2026Class IIMedline medical convenience kits packaged as: ADULT CATH SECUREMENT DRSG, Kit SKU...MEDLINE INDUSTRIES, LP - NorthfieldOES
Z-1326-2026Class IIMedline medical convenience kits packaged as: ANESTHESIA ARTLINE PACK, Kit SKU DYNJ47387BMEDLINE INDUSTRIES, LP - NorthfieldCAI
Z-1112-2026Class IIGE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend...GE Medical Systems Israel, Functional ImagingKPS
Z-1202-2026Class IIBrand Name: Zimmer Tourniquet Systems Product Name: A.T.S. 3200TS Tourniquet...Zimmer Surgical SAKCY
Z-1201-2026Class IIBrand Name: Zimmer Tourniquet Systems Product Name: A.T.S. 5000TS Tourniquet...Zimmer Surgical SAKCY
Z-1235-2026Class IICellMek SPS Sample Preparation System, REF: C44603, with softwareSiemens Healthcare Diagnostics Inc.PER
Z-1243-2026Class IIFocalyx FusionFocalyx TechnologiesLLZ
Z-1325-2026Class IReprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav...MEDLINE INDUSTRIES, LP - NorthfieldOWQ
Z-1324-2026Class IReprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense...MEDLINE INDUSTRIES, LP - NorthfieldOWQ
Z-1323-2026Class IMedline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter 9F x...MEDLINE INDUSTRIES, LP - NorthfieldOWQ
Z-1322-2026Class IReprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St...MEDLINE INDUSTRIES, LP - NorthfieldNLH
Z-1321-2026Class IReprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire...MEDLINE INDUSTRIES, LP - NorthfieldNLH
Z-1320-2026Class IReprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry Steerable...MEDLINE INDUSTRIES, LP - NorthfieldNLH
Z-1319-2026Class IMedline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes...MEDLINE INDUSTRIES, LP - NorthfieldNLH
Z-1219-2026Class IILSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical...LSL HealthcareOWL
Z-1156-2026Class IIPatient Information Center iX; Software Version Number: 4.5.0Philips North America LLCMHX
Z-1561-2026Class IIBrand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens...Altruan GmbHGTY
Z-1560-2026Class IIClearest Strep-A Cassette Test. Test to determine the presence of group A streptococci...Altruan GmbHGTY
Z-1559-2026Class IIWondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic...Altruan GmbHGTY
Z-1242-2026Class IINAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel...Siemens Medical Solutions USA, Inc.JAK
Z-1241-2026Class IINAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel...Siemens Medical Solutions USA, Inc.JAK
Z-1240-2026Class IINAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel...Siemens Medical Solutions USA, Inc.JAK
Z-1239-2026Class IISOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel...Siemens Medical Solutions USA, Inc.JAK
Z-1163-2026Class I*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material...Boston Scientific CorporationKNS
Z-1162-2026Class I*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number...Boston Scientific CorporationKNS
Z-1161-2026Class IHOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number...Boston Scientific CorporationKNS
Z-1160-2026Class IAXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number...Boston Scientific CorporationKNS
Z-1159-2026Class IAXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number...Boston Scientific CorporationKNS
Z-1158-2026Class IAXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number...Boston Scientific CorporationKNS
Z-1133-2026Class IIBrand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog...Microport Orthopedics Inc.N/A
Z-1132-2026Class IIBrand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate...Tyber MedicalHRS
Z-1131-2026Class IIBrand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate...Tyber MedicalHRS
Z-1101-2026Class IIPortex Spinal Tray, Item No. A3729-24 A3595Abbott MedicalCAZ
Z-1100-2026Class IIPulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PGAbbott MedicalJKA
Z-1111-2026Class IITego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000Abbott MedicalFPA
Z-1237-2026Class IITORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318TORNIER Inc.KWS
Z-1018-2026Class IIVANTAGE TITAN 3T Model MRT-3010/MEXL-3010Canon Medical Systems USA, Inc.LNH
Z-1017-2026Class IIVANTAGE GALAN 3T Model MRT-3020/MEXL-3020Canon Medical Systems USA, Inc.LNH
Z-1179-2026Class IIAlphenix INFX-8000V, interventional fluoroscopic x-ray systemCanon Medical Systems USA, Inc.OWB
Z-1178-2026Class IIAlphenix INFX-8000H, interventional fluoroscopic x-ray systemCanon Medical Systems USA, Inc.OWB
Z-1177-2026Class IIAlphenix INFX-8000F, interventional fluoroscopic x-ray systemCanon Medical Systems USA, Inc.OWB
Z-1176-2026Class IIAlphenix INFX-8000C, interventional fluoroscopic x-ray systemCanon Medical Systems USA, Inc.OWB
Z-1492-2026Class IIGelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE...Vascutek, Ltd.DSY
Z-1362-2026Class IITeslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code...Wilson-Cook Medical Inc.KNS
Z-1139-2026Class IIRifton Equipment, E-Pacer. Model/Catalog Number: K660. The E-Pacer is a gait training...Community Products, LLCFSA
Z-1138-2026Class IIRifton Equipment, Low Base TRAM. Model/Catalog Number: K320. The TRAM is a powered lift...Community Products, LLCFSA