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 116 of 1190
FDA device recalls, page 116 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0043-2025Class IINxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468Luminex Molecular Diagnostics IncQLT
Z-0042-2025Class IINxTAG Respiratory Pathogen Panel, REF: I051C0447Luminex Molecular Diagnostics IncOCC
Z-0063-2025Class II1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling...Stryker Corp.HBE
Z-0116-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE...Boston Scientific CorporationDQK
Z-0115-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE...Boston Scientific CorporationDQK
Z-0114-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE...Boston Scientific CorporationDQK
Z-0113-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE...Boston Scientific CorporationDQK
Z-0112-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE...Boston Scientific CorporationDQK
Z-0111-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + MOB Z...Boston Scientific CorporationDQK
Z-0110-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + INT Z...Boston Scientific CorporationDQK
Z-0109-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US; the...Boston Scientific CorporationDQK
Z-0108-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM JAPAN; the...Boston Scientific CorporationDQK
Z-0107-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL US...Boston Scientific CorporationDQK
Z-0106-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL EU +...Boston Scientific CorporationDQK
Z-0105-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL - ZERO...Boston Scientific CorporationDQK
Z-0104-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EU + ROW...Boston Scientific CorporationDQK
Z-0103-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST...Boston Scientific CorporationDQK
Z-0102-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST...Boston Scientific CorporationDQK
Z-0101-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST...Boston Scientific CorporationDQK
Z-0100-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM US; the...Boston Scientific CorporationDQK
Z-0099-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM JAPAN; the...Boston Scientific CorporationDQK
Z-0098-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM EU + ROW...Boston Scientific CorporationDQK
Z-0097-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST...Boston Scientific CorporationDQK
Z-0096-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST...Boston Scientific CorporationDQK
Z-0095-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO+ BRIDGE TO INTEGRATED...Boston Scientific CorporationDQK
Z-0264-2025Class IIOlympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327UOLYMPUS Corporation of the AmericasGEI
Z-0136-2025Class IIbk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive...BK Medical ApSIYN
Z-0180-2025Class IIMedline EYE PACK, REF LYN036EPESB; medical procedure convenience kitMEDLINE INDUSTRIES, LP - NorthfieldOJK
Z-0179-2025Class IIMedline brand medical procedure convenience kits, labeled as: 1) NEW LONDON TOTAL KNEE...MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-0178-2025Class IIMedline brand medical procedure convenience kits, labeled as: 1) EYE PACK, REF...MEDLINE INDUSTRIES, LP - NorthfieldOJK
Z-0177-2025Class IIMedline brand medical procedure convenience kits, labeled as: a) OB PACK-LF, REF...MEDLINE INDUSTRIES, LP - NorthfieldOKV
Z-0176-2025Class IIMedline brand medical procedure convenience kits, labeled as: a) ABDOMINAL HYSTERECTOMY...MEDLINE INDUSTRIES, LP - NorthfieldOJF
Z-0175-2025Class IIMedline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK, REF...MEDLINE INDUSTRIES, LP - NorthfieldOHD
Z-0174-2025Class IIMedline brand medical procedure convenience kits, labeled as: 1) L&D/OB PACK-LF, REF...MEDLINE INDUSTRIES, LP - NorthfieldMLS
Z-0173-2025Class IIMedline brand medical procedure convenience kits, labeled as: a) NEURO PACK, REF...MEDLINE INDUSTRIES, LP - NorthfieldOJG
Z-0172-2025Class IIMedline AMBULATORY MINI PACK, REF DYNJ82579; medical procedure convenience kitMEDLINE INDUSTRIES, LP - NorthfieldNSB
Z-0171-2025Class IIMedline brand medical procedure convenience kits, labeled as: a) UNIVERSAL DRAPE PACK...MEDLINE INDUSTRIES, LP - NorthfieldKKX
Z-0170-2025Class IIMedline TUBAL LIGATION PACK, REF DYNJ66230B; medical procedure convenience kitMEDLINE INDUSTRIES, LP - NorthfieldPKD
Z-0169-2025Class IIMedline PEDIATRIC DRAPE PK, REF DYNJ81297; medical procedure convenience kitMEDLINE INDUSTRIES, LP - NorthfieldOXQ
Z-0168-2025Class IIMedline IV TEAM PICC, REF DYNJ48222; medical procedure convenience kitMEDLINE INDUSTRIES, LP - NorthfieldLRS
Z-0167-2025Class IIMedline CHEST TUBE INSERTION TRAY ADUL, REF CHT1165; medical procedure convenience kitMEDLINE INDUSTRIES, LP - NorthfieldLRP
Z-0166-2025Class IIMedline brand medical procedure convenience kits, labeled as: 1) THORACENTESIS TRAY, REF...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-0165-2025Class IIMedline brand medical procedure convenience kits, labeled as: a) PLASTIC PACK, REF...MEDLINE INDUSTRIES, LP - NorthfieldFTN
Z-0164-2025Class IIMedline brand medical procedure convenience kits, labeled as: a) TRAY ADD A CATH FOL UM...MEDLINE INDUSTRIES, LP - NorthfieldPPB
Z-0163-2025Class IIMedline DIALYSIS PACK, REF DYNJ36932A; medical procedure convenience kitMEDLINE INDUSTRIES, LP - NorthfieldPEV
Z-0162-2025Class IIMedline CENTRAL CATHETER INSERTION TRA, REF CVI680C; medical procedure convenience kitMEDLINE INDUSTRIES, LP - NorthfieldOHR
Z-0161-2025Class IIMedline brand medical procedure convenience kits, labeled as: 1) CYSTO CDS, REF...MEDLINE INDUSTRIES, LP - NorthfieldFDE
Z-0160-2025Class IIMedline brand medical procedure convenience kits, labeled as: 1) T&A CDS-LF, REF...MEDLINE INDUSTRIES, LP - NorthfieldOGR
Z-0159-2025Class IIMedline DENTAL PACK, REF DYNJ64086B; medical procedure convenience kitMEDLINE INDUSTRIES, LP - NorthfieldOFX
Z-0158-2025Class IIMedline brand medical procedure convenience kits, labeled as: a) CONE BIOPSY PACK, REF...MEDLINE INDUSTRIES, LP - NorthfieldOFG