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 145 of 1190
FDA device recalls, page 145 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2990-2024Class IIMedline Convenience kits labeled as: 1) KIT MANIFOLD CSTM-NORTHRIDGE, Pack Number...MEDLINE INDUSTRIES, LP - NorthfieldDTL
Z-2989-2024Class IIMedline Convenience kits, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU, Pack Number...MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-2988-2024Class IIMedline Convenience kits, labeled as: 1) NERVE BLOCK TRAY-LF, Pack Number DYNJRA0377B...MEDLINE INDUSTRIES, LP - NorthfieldOJG
Z-2987-2024Class IIMedline Convenience kits, labeled as: 1) SINGLE SHOT EPIDURAL PACK-LF, Pack Number...MEDLINE INDUSTRIES, LP - NorthfieldOGE
Z-2986-2024Class IIMedline Convenience kits labeled as: 1) STERILE LIDOCAINE SYRINGE PACK, Pack Number...MEDLINE INDUSTRIES, LP - NorthfieldOGD
Z-2985-2024Class IIMedline Convenience kits, labeled as: 1) DYNJ39451D , Pack Number HOOD PACK ; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOFR
Z-2984-2024Class IIMedline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 2)...MEDLINE INDUSTRIES, LP - NorthfieldNXA
Z-2983-2024Class IIMedline Convenience kits, labeled as: 1) GAS SAM LINE .06ID 10FT MM FLT, Pack Number...MEDLINE INDUSTRIES, LP - NorthfieldCAI
Z-2982-2024Class IIMedline Convenience kits, labeled as: 1) TRACH CDS-LF , Pack Number CDS983142B ; 2)...MEDLINE INDUSTRIES, LP - NorthfieldCAE
Z-2981-2024Class IIMedline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 2)...MEDLINE INDUSTRIES, LP - NorthfieldBSY
Z-2780-2024Class IICenturion procedure packs, containing Caina syringes, labeled as: 1) BREAST BIOPSY...MEDLINE INDUSTRIES, LP - NorthfieldOHG
Z-2779-2024Class IICenturion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAM TRAY...MEDLINE INDUSTRIES, LP - NorthfieldMLS
Z-2778-2024Class IICenturion procedure packs, containing Caina syringes, labeled as: SHAVE KIT, Pack...MEDLINE INDUSTRIES, LP - NorthfieldOJU
Z-2777-2024Class IICenturion procedure packs, containing Caina syringes, labeled as: 1) CIRCUMCISION...MEDLINE INDUSTRIES, LP - NorthfieldLRS
Z-2776-2024Class IICenturion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAM, Pack...MEDLINE INDUSTRIES, LP - NorthfieldLRP
Z-2775-2024Class IICenturion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAPH TRAY...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-2774-2024Class IICenturion procedure packs, containing Caina syringes, labeled as: 1) NICU CIRCUMCISION...MEDLINE INDUSTRIES, LP - NorthfieldOGR
Z-2765-2024Class IIMedline procedural kits labeled as: 1) AFCH ANTERIOR SEGMENT PK, Pack Number DYNJ63330B...MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-2764-2024Class IIMedline procedural kits labeled as: 1) ALL DOC EYE PACK, Pack Number DYNJ51654A ; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOJK
Z-2763-2024Class IIMedline procedural kits labeled as: 1) LEEP PACK, Pack Number DYNJ40348G; 2) TRAB...MEDLINE INDUSTRIES, LP - NorthfieldOJF
Z-2762-2024Class IIMedline procedural kits labeled as: 1) SR C SECTION, Pack Number DYNJ908584; 2) SR C...MEDLINE INDUSTRIES, LP - NorthfieldOHM
Z-2761-2024Class IIMedline Procedure kits labeled as: 1) CIRCUMCISION SET, Pack Number CIT6335; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOHG
Z-2760-2024Class IIMedline procedural kits labeled as: 1) INFANT DELIVERY KIT , Pack Number DYKM1426; 2)...MEDLINE INDUSTRIES, LP - NorthfieldMLS
Z-2759-2024Class IIMedline procedural kits labeled as: NEURO TRAY, Pack Number DYNJ55909BMEDLINE INDUSTRIES, LP - NorthfieldOJG
Z-2758-2024Class IIMedline procedural kits labeled as: 1) GLMI ARTHROGRAM KIT:PCL, Pack Number SPEC0300B...MEDLINE INDUSTRIES, LP - NorthfieldPWY
Z-2757-2024Class IIMedline procedural kits labeled as: 1) BABY ADMIT, Pack Number DYKB1011C; 2) BABY...MEDLINE INDUSTRIES, LP - NorthfieldNSB
Z-2756-2024Class IIMedline procedural kits labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6715; 2) NICU...MEDLINE INDUSTRIES, LP - NorthfieldPXP
Z-2755-2024Class IIMedline procedural kits labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6715; 2) NICU...MEDLINE INDUSTRIES, LP - NorthfieldOXQ
Z-2754-2024Class IIMedline procedural kits labeled as: ARTHROGRAPH TRAY, Pack Number MNS12670AMEDLINE INDUSTRIES, LP - NorthfieldOIB
Z-2753-2024Class IIMedline procedural kits labeled as: UMBILICAL LINE KIT W/FOAM, Pack Number DYNDL1588AMEDLINE INDUSTRIES, LP - NorthfieldMCY
Z-2752-2024Class IIMedline procedural kits labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2)...MEDLINE INDUSTRIES, LP - NorthfieldLRP
Z-2751-2024Class IIMedline procedural kits labeled as: 1) DRAWER 3 LAB DRAW & IV START, Pack Number...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-2750-2024Class IIMedline procedural kits labeled as: 1) BOTOX KIT - CHRONIC MIGRAINE, Pack Number...MEDLINE INDUSTRIES, LP - NorthfieldFTN
Z-2749-2024Class IIMedline procedural kits labeled as: CIRCUMCISION TRAY, Pack Number DYNDA2271MEDLINE INDUSTRIES, LP - NorthfieldOHG
Z-2748-2024Class IIMedline procedural kits labeled as: 1) FETAL SURGERY-LF, Pack Number CDS840214Q...MEDLINE INDUSTRIES, LP - NorthfieldFDE
Z-2747-2024Class IIMedline procedural kits labeled as: 1) TYMPANOPLASTY , Pack Number CDS980203S; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOGR
Z-2746-2024Class IIMedline procedural kits labeled as: 1) BIOPSY PACK, Pack Number DYNJ63370A; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOFG
Z-2745-2024Class IIMedline procedural kits labeled as: 1) CAROTID ENDARTERECTOMY PK, Pack Number...MEDLINE INDUSTRIES, LP - NorthfieldOFF
Z-2744-2024Class IIMedline procedural kits labeled as: 1) MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780...MEDLINE INDUSTRIES, LP - NorthfieldOFD
Z-2743-2024Class IIMedline procedural kits labeled as: 1) OPEN HEART PEDS, Pack Number CDS981050Q; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-2742-2024Class IIMedline procedural kits labeled as: 1) PERIPHERAL ULTRASOUND CATHETER INSERTION, Pack...MEDLINE INDUSTRIES, LP - NorthfieldOES
Z-2741-2024Class IIMedline procedural kits labeled as: PREOP NERVE BLOCK TRAY, Pack Number DYNJRA2040HMEDLINE INDUSTRIES, LP - NorthfieldOFT
Z-2740-2024Class IIMedline procedural kits labeled as: 1) BABY CARE KIT UNIV, Pack Number DYKL1025; 2)...MEDLINE INDUSTRIES, LP - NorthfieldCCX
Z-2739-2024Class IIMedline procedural kits labeled as: 1) ANESTHESIA CIRCUIT PEDS-LF, Pack Number...MEDLINE INDUSTRIES, LP - NorthfieldCAI
Z-2773-2024Class IICenturion procedure packs, labeled as: 1) BIOPSY TRAY-LF, Pack Number SPEC4380; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOHG
Z-2772-2024Class IICenturion procedure kits, labeled as: 1) ARTHROGRAM TRAY, Pack Number DYNDH1349; 2)...MEDLINE INDUSTRIES, LP - NorthfieldMLS
Z-2771-2024Class IICenturion procedure kits, labeled as: 1) BREAST BIOPSY KIT, Pack Number MNS6950A; 2)...MEDLINE INDUSTRIES, LP - NorthfieldPXP
Z-2770-2024Class IICenturion procedure kits labeled as: 1) BONE MARROW TRAY, Pack Number SPEC0255; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOXQ
Z-2769-2024Class IICenturion procedure kits labeled as: UMBILICAL VESSEL TRAY, Pack Number UVT1100MEDLINE INDUSTRIES, LP - NorthfieldLRS
Z-2768-2024Class IICenturion procedure kits labeled as: 1) 3" RADIAL ARTERIAL LINE KIT- ICU, Pack Number...MEDLINE INDUSTRIES, LP - NorthfieldLRP