510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

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 7 of 1187
FDA device recalls, page 7 of 1187
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2929-2026Class IIGM Helix Implant, Endosseous Dental Implant Article No. 109.984Straumann USA, LLCNHA
Z-2993-2026Class IIMedline breathing circuits labeled as: 1) MEDLINE HUDSON RCI, CIRCUIT, NEO, SING LIMB...MEDLINE INDUSTRIES, LP - NorthfieldOGG
Z-2992-2026Class IIMedline breathing circuits labeled as: 1) HUDSON RCI, CIRCUIT, HTD, DL, NEONATE, 48...MEDLINE INDUSTRIES, LP - NorthfieldBZO
Z-2991-2026Class IIMedline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU...MEDLINE INDUSTRIES, LP - NorthfieldBTT
Z-2980-2026Class IIMiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;Medtronic, Inc.QFG
Z-2957-2026Class IIBrand Name: Kico Knee Innovation Product Name: ARVIS SURGICAL NAVIGATION SYSTEM GEN...Kico Knee Innovation CompanySBF
Z-3029-2026Class IIMedline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS982035Y; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-3028-2026Class IIMedline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU...MEDLINE INDUSTRIES, LP - NorthfieldOKV
Z-3027-2026Class IIMedline convenience kits labeled as: 1) LAVH, Medline Kit SKU CDS982273U; 2) GYN...MEDLINE INDUSTRIES, LP - NorthfieldOJF
Z-3026-2026Class IIMedline convenience kits labeled as: 1) C-SECTION, Medline Kit SKU DYNJ904612L; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOHM
Z-3025-2026Class IIMedline convenience kits labeled as: 1) GYN ROBOTIC CDS, Medline Kit SKU CDS982888Q...MEDLINE INDUSTRIES, LP - NorthfieldOHD
Z-3024-2026Class IIMedline convenience kits labeled as: 1) MAJOR GYN PACK, Medline Kit SKU DYNJG001030C...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-3023-2026Class IIMedline convenience kits labeled as: LTP CDS-LF, Medline kit SKU CDS980375MMEDLINE INDUSTRIES, LP - NorthfieldFTN
Z-3022-2026Class IIMedline convenience kits labeled as: 1) MAJOR PROCEDURE, Medline Kit SKU CDS982040U...MEDLINE INDUSTRIES, LP - NorthfieldFDE
Z-3021-2026Class IIMedline convenience kits labeled as: MAJOR HEAD AND NECK PPS, Medline Kit SKU...MEDLINE INDUSTRIES, LP - NorthfieldOGR
Z-3020-2026Class IIMedline convenience kits labeled as: 1) OPEN HEART PACK, Medline Kit SKU CDS840393P...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-3019-2026Class IIMedline convenience kits labeled as: 1) FEMORAL PACK, Medline Kit SKU DYNJ909393A; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOES
Z-2999-2026Class IIMedline medical convenience kit labeled as: TRACH TUBE KIT, Medline Kit SKU DYKM2330MEDLINE INDUSTRIES, LP - NorthfieldOFR
Z-2972-2026Class IIICustom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number...Paragon 28PLF
Z-2971-2026Class IIICustom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number...Paragon 28PLF
Z-2878-2026Class IIGE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592GE Medical Systems Information Technologies, Inc.MWI
Z-2964-2026Class IIHalyard LAVH PACK, Model/Catalog Number: USAR053-11Avid Medical, Inc. a Medical Action Ind. Company 305OKV
Z-3011-2026Class IIHalyard TOTAL JOINT Model/Catalog Number: MSBM036-03Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-3010-2026Class IIHalyard TOTAL JOINT Model/Catalog Number: MSBM036-03Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-3009-2026Class IIHalyard TOTAL JOINT Model/Catalog Number: MSBM036-03Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-3008-2026Class IIHalyard TOTAL JOINT Model/Catalog Number: MSBM036-03Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-3007-2026Class IIHalyard TOTAL JOINT Model/Catalog Number: MSBM036-03Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-3006-2026Class IIHalyard TOTAL JOINT Model/Catalog Number: MSBM036-03Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-3005-2026Class IIBrand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR...Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-3016-2026Class IIGrandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product Codes: 1)...Henry Schein, Inc.EBF
Z-3015-2026Class IIStructur 2 SC Temporary Resin Cartridge Refill 75Gm, Product Codes: 1) 114-3933, Mfr...Henry Schein, Inc.EBF
Z-2978-2026Class IBoston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number...Boston Scientific CorporationNTE
Z-2977-2026Class IBoston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number...Boston Scientific CorporationNTE
Z-2997-2026Class IIMedline medical convenience kits, labeled as: 1) LAMINECTOMY PACK, Medline Kit SKU...MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-2996-2026Class IIMedline medical convenience kits, labeled as: 1) NEURO CDS, Medline Kit SKU CDS985246J...MEDLINE INDUSTRIES, LP - NorthfieldOJG
Z-2995-2026Class IIMedline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline Kit SKU...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-2994-2026Class IIMedline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit SKU...MEDLINE INDUSTRIES, LP - NorthfieldOGR
Z-2960-2026Class IITD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799Tobii Dynavox LLCILQ
Z-2959-2026Class IITD Navio Midi Speech Generating Device Model/Catalog Number: 1000798Tobii Dynavox LLCILQ
Z-2983-2026Class IIFort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131Fort Defiance Industries, LLCFLE
Z-2837-2026Class IIKingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected...Integrated Medcraft LLCOHO
Z-2836-2026Class IIFORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002...Integrated Medcraft LLCCAE
Z-2761-2026Class IIOlympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual...OLYMPUS Corporation of the AmericasGCJ
Z-3213-2026Class IIPi-Cardia Inc. ShortCut REF: Z-A-20.003-USPi Cardia LtdSCZ
Z-2986-2026Class IIEsteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705...ConvaTec LimitedEXG
Z-2934-2026Class IIEndo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating...Waldemar Link GmbH & Co. KGKRO
Z-2890-2026Class IIAtellica CH Urine Albumin REF: 11537225Siemens Healthcare Diagnostics Inc.JIR
Z-2873-2026Class IBrand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection...Spectra Medical Devices, LLCNGT
Z-2820-2026Class IIOsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis...IsoTis OrthoBiologics, Inc.MQV
Z-2956-2026Class IICardiac Workstation 7000. Product Number: 860441.Philips North America LLCDPS