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 39 of 1187
FDA device recalls, page 39 of 1187
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1233-2026Class IIEMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705Encore Medical, LPJWH
Z-1343-2026Class IIATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF...Alphatec Spine, Inc.OLO
Z-1342-2026Class IIATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF...Alphatec Spine, Inc.OLO
Z-1338-2026Class IIHalyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-1370-2026Class IIMedica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.Medica Corp.CEM
Z-1366-2026Class IIMedline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN...MEDLINE INDUSTRIES, LP - NorthfieldFPA
Z-1426-2026Class IIBrand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software...Centinel Spine, LLCMJO
Z-1220-2026Class IIBEAR Implant. Model Number: 1000.Miach OrthopaedicsQNI
Z-1355-2026Class IIda Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number...Intuitive Surgical, Inc.NAY
Z-1827-2026Class IWHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an...Whill, Inc.ITI
Z-1826-2026Class IWHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an...Whill, Inc.ITI
Z-1175-2026Class IIInterventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number...Siemens Medical Solutions USA, Inc.OWB
Z-1174-2026Class IIInterventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number...Siemens Medical Solutions USA, Inc.OWB
Z-1165-2026Class IIPearMatrix P-15 Peptide Enhanced Bone Graft Bone Graft, 1.0cc REF: 730-010Cerapedics, Inc.NOX
Z-1184-2026Class IIPregnancy Test 24CtGold Star Distribution IncLCX
Z-1183-2026Class IIToothbrushes, labeled as: ORAL B TOOTH BRUSH SHINY CLEAN SOFT 12CT; COLGATE TOOTH BRUSH...Gold Star Distribution IncEFW
Z-1182-2026Class IIFeminine hygiene products, labeled as: KOTEX FREEDOM MAXI NO WINGS 48CT, ALWAYS THIN...Gold Star Distribution IncHEB
Z-1181-2026Class IICondoms, labeled as: TROJAN MAGNUM CONDOMS 6/DSP BLACK, TROJAN LUBRICATED CONDOMS 6/DSP...Gold Star Distribution IncHIS
Z-1180-2026Class IIBandages and first aid kits: FIRST AID KIT 24/42PC, LUCKY FIRST AID BANDAGES 24CTGold Star Distribution IncKGX
Z-1203-2026Class IIChest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal...Medtronic, Inc.GCX
Z-1313-2026Class IIIntubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245BMEDLINE INDUSTRIES, LP - NorthfieldCAI
Z-1312-2026Class IIMedline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kitMEDLINE INDUSTRIES, LP - NorthfieldOFR
Z-1336-2026Class IIMedline medical convenience kits packaged as: MERCY CIRCUMCISION TRAY, Kit SKU CIT6135BMEDLINE INDUSTRIES, LP - NorthfieldOHG
Z-1335-2026Class IIMedline medical convenience kits packaged as: STERILE RESUTURE PACK, Kit SKU DYNDL1980AMEDLINE INDUSTRIES, LP - NorthfieldPKD
Z-1334-2026Class IIMedline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY, Kit SKU...MEDLINE INDUSTRIES, LP - NorthfieldOXQ
Z-1333-2026Class IIMedline medical convenience kits packaged as: BLOOD CULTURE KIT NS, Kit SKU DYNDH2088MEDLINE INDUSTRIES, LP - NorthfieldOIB
Z-1332-2026Class IIMedline medical convenience kits packaged as: SUTURE REMOVAL TRAY, Kit SKU DYNDR1277AMEDLINE INDUSTRIES, LP - NorthfieldMCZ
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