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 105 of 1190
FDA device recalls, page 105 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0672-2025Class IIBD Pyxis CII Safe ES, REF: 1116-00CareFusion 303, IncBRY
Z-0671-2025Class IIBD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324CareFusion 303, IncBRY
Z-0670-2025Class IIBD Pyxis MedStation ES, REF: 323CareFusion 303, IncBRY
Z-1326-2025Class IIDxI 9000 Access Immunoassay Analyzer, Catalog Number C11137Siemens Healthcare Diagnostics Inc.JJE
Z-0835-2025Class IIBrand Name: Alcon Product Name: Monarch III D Delivery Cartridge Model/Catalog Number...Alcon LaboratoriesKYB
Z-0760-2025Class IIRUMMELL, Medline Item No. ST006STMEDLINE INDUSTRIES, LP - NorthfieldLRP
Z-0759-2025Class IIST IUD REMOVAL HOOK 10" (504090), Medline Item No. I68785MEDLINE INDUSTRIES, LP - NorthfieldGDG
Z-0758-2025Class IIST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600KMEDLINE INDUSTRIES, LP - NorthfieldHTF
Z-0757-2025Class IISTERILE MAGILL FORCEP (MAGF9), Medline Item No. 66790MEDLINE INDUSTRIES, LP - NorthfieldGEN
Z-0756-2025Class IIST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Medline Item No. 67870MEDLINE INDUSTRIES, LP - NorthfieldGEN
Z-0755-2025Class IIO.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000MEDLINE INDUSTRIES, LP - NorthfieldLRW
Z-0754-2025Class IISTERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695MEDLINE INDUSTRIES, LP - NorthfieldHRQ
Z-0808-2025Class IIAerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack)...Aerin Medical, Inc.GEI
Z-0767-2025Class IIMagnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material...Siemens Healthcare Diagnostics Inc.JGJ
Z-0572-2025Class IITriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)Gauthier Biomedical, Inc.LXH
Z-0676-2025Class IIPhilips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10...Philips Medical Systems Nederland B.V.OWB
Z-1137-2025Class IICardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA; 2) ACDF PACK...Medtronic, Inc.PVP
Z-1136-2025Class IICardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog...Medtronic, Inc.OJK
Z-1135-2025Class IICardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2)...Medtronic, Inc.OJH
Z-1134-2025Class IICardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog...Medtronic, Inc.OJG
Z-1133-2025Class IICardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA; 2)...Medtronic, Inc.OJF
Z-1132-2025Class IICardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog...Medtronic, Inc.OGR
Z-1131-2025Class IICardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET0979N;Medtronic, Inc.OGH
Z-1130-2025Class IICardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog...Medtronic, Inc.OFX
Z-1129-2025Class IICardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog...Medtronic, Inc.OEZ
Z-1128-2025Class IICardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA; 2)...Medtronic, Inc.NWU
Z-1127-2025Class IICardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog...Medtronic, Inc.LRP
Z-1126-2025Class IICardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog...Medtronic, Inc.LRO
Z-0917-2025Class IICardinal Health Presource Kits: 1) KIT, H N FREE FLAP, Catalog Number: PEHFHNAMHJ; 2)...Medtronic, Inc.OJK
Z-0916-2025Class IICardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number...Medtronic, Inc.OJH
Z-0915-2025Class IICardinal Health Presource Kits: 1) CRANIOTOMY PACK, Catalog Number: 2NE69CNK12; 2) CHI...Medtronic, Inc.OJG
Z-0914-2025Class IICardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10 2 ) KIT...Medtronic, Inc.OHD
Z-0913-2025Class IICardinal Health Presource Kits: 0 ) DESCRIPTION Catalog Number: CATALOG #; 1 ) KIT, NASAL...Medtronic, Inc.OGR
Z-0912-2025Class IICardinal Health Presource Kits: 1 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH2 ; 2 )...Medtronic, Inc.OGH
Z-0911-2025Class IICardinal Health Presource Kits: 1 ) KIT, MAJOR ORAL SURGERY, Catalog Number: PGDHMOWOE; 2...Medtronic, Inc.OFX
Z-0910-2025Class IICardinal Health Presource Kits: 1 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM1; 2 )...Medtronic, Inc.OEZ
Z-0909-2025Class IICardinal Health Presource Kits: 1 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHH1:; 2...Medtronic, Inc.NWU
Z-0908-2025Class IICardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951; 2) KIT,ORP...Medtronic, Inc.LRO
Z-0729-2025Class IIO&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code...O&M Halyard, Inc.FXX
Z-0728-2025Class IIO&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical...O&M Halyard, Inc.FXX
Z-0673-2025Class IIAccess Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number...Siemens Healthcare Diagnostics Inc.CEW
Z-0694-2025Class IIPanther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400Hologic, Inc.QOF
Z-0677-2025Class IIDiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of...Diasorin Inc.NXO
Z-0726-2025Class IIMedline brand, medical procedure convenience kits, labeled as: 1) LAMINECTOMY CDS-LF...MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-0725-2025Class IIKIT,SPINE LH Convenience kit, SKU DYNJ906448A.MEDLINE INDUSTRIES, LP - NorthfieldOHD
Z-0724-2025Class IIMedline brand, medical procedure convenience kits, labeled as: 1) NEURO CRANIOTOMY CDS...MEDLINE INDUSTRIES, LP - NorthfieldOJG
Z-0723-2025Class IIMedline brand, medical procedure convenience kits, labeled as: 1) CRANIOTOMY, SKU...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-0722-2025Class IISEPTOPLASTY PACK Convenient kit, SKU DYNJ44759F. Convenience kits used for various...MEDLINE INDUSTRIES, LP - NorthfieldFTN
Z-0721-2025Class IIMedline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #54-RF , SKU...MEDLINE INDUSTRIES, LP - NorthfieldFDE
Z-0720-2025Class IIMedline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1, SKU...MEDLINE INDUSTRIES, LP - NorthfieldOGR