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 87 of 1190
FDA device recalls, page 87 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1711-2025Class IIMedline procedure kits, labeled as: 1) WOUND CARE TRAY, REF DYNDA1412A; 2) LACERATION...MEDLINE INDUSTRIES, LP - NorthfieldMCY
Z-1710-2025Class IIMedline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535MEDLINE INDUSTRIES, LP - NorthfieldLRP
Z-1709-2025Class IIMedline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; 2) STRL EK...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-1708-2025Class IIMedline procedure kits, labeled as: NON STERILE I&D KIT, REF DYKM1438MEDLINE INDUSTRIES, LP - NorthfieldFDE
Z-1707-2025Class IIMedline procedure kits, labeled as: T AND A PACK -LF, REF DYNJ85792MEDLINE INDUSTRIES, LP - NorthfieldOGR
Z-1706-2025Class IIMedline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296MEDLINE INDUSTRIES, LP - NorthfieldFRO
Z-1705-2025Class IIMedline Sterile Water, USP, 100mL, REF RDI30295MEDLINE INDUSTRIES, LP - NorthfieldFRO
Z-1696-2025Class IIBrand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, Physiological...Spectrum Medical IncMWI
Z-1695-2025Class IIBrand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient...Spectrum Medical IncMWI
Z-1528-2025Class IBrand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number...Halyard HealthBSY
Z-1527-2025Class IBrand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number...Halyard HealthBSY
Z-1526-2025Class IBrand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number...Halyard HealthBSY
Z-1525-2025Class IBrand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number...Halyard HealthBSY
Z-1524-2025Class IBrand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number...Halyard HealthBSY
Z-1523-2025Class IBrand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number...Halyard HealthBSY
Z-1522-2025Class IBrand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number...Halyard HealthBSY
Z-1521-2025Class IBrand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number...Halyard HealthBSY
Z-1685-2025Class IIepoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material...Siemens Healthcare Diagnostics Inc.CHL
Z-1684-2025Class IIepoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material...Siemens Healthcare Diagnostics Inc.CHL
Z-1694-2025Class IIAutomated External Defibrillators, Model DDU-2200, IItem numbers...Defibtech LLCMKJ
Z-1693-2025Class IIAutomated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German...Defibtech LLCMKJ
Z-1692-2025Class IIAutomated External Defibrillators, Model DDU-2300. Item numbers...Defibtech LLCMKJ
Z-1691-2025Class IIAutomated External Defibrillators, Model DDU-2200, IItem numbers...Defibtech LLCMKJ
Z-1690-2025Class IISemi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers...Defibtech LLCMKJ
Z-1806-2025Class IIMeta-Tan Lag/compression Screw Kit 90Mm/85mm, Ref: 71642690Smith & Nephew, Inc.HSB
Z-1656-2025Class IIBrand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number...Abbott MedicalGKZ
Z-1655-2025Class IIBrand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number...Abbott MedicalGKZ
Z-1654-2025Class IIBrand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number...Abbott MedicalGKZ
Z-1653-2025Class IIBrand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number...Abbott MedicalGKZ
Z-1652-2025Class IIBrand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number...Abbott MedicalGKZ
Z-1644-2025Class IIAmplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080Abbott MedicalDQY
Z-1643-2025Class IIAmplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080Abbott MedicalDQY
Z-1672-2025Class IIDxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 /...Siemens Healthcare Diagnostics Inc.JJE
Z-1490-2026Class IIEsaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038Esaote S.p.A.ITX
Z-1860-2025Class IIDORO Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)Black Forest Medical GmbHHBL
Z-1641-2025Class IIMerit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1)...Merit Medical Systems, Inc.ODE
Z-1640-2025Class IIMerit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnlyMerit Medical Systems, Inc.ODE
Z-2220-2025Class IIBrand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage...Institut Georges LopezMSB
Z-1570-2025Class IHeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK...Abbott MedicalDSQ
Z-1504-2025Class IIBrand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number...QiagenQOF
Z-1585-2025Class IBrand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog...Conavi Medical IncOBJ
Z-1499-2025Class IBrand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex...Draeger, Inc.OFP
Z-1498-2025Class IBrand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex...Draeger, Inc.OFP
Z-1497-2025Class IBrand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex...Draeger, Inc.OFP
Z-1496-2025Class IBrand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex...Draeger, Inc.OFP
Z-1495-2025Class IBrand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex...Draeger, Inc.OFP
Z-1494-2025Class IBrand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Number...Draeger, Inc.BZO
Z-1493-2025Class IBrand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number...Draeger, Inc.CAI
Z-1639-2025Class IIBD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-137; MINI...CareFusion 303, IncBRY
Z-1545-2025Class IIBD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis"...CareFusion 303, IncBRY