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 106 of 1190
FDA device recalls, page 106 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0719-2025Class IIDIEP FLAP Convenience kit, SKU DYNJ910120. Convenience kits used for various procedures.MEDLINE INDUSTRIES, LP - NorthfieldOFG
Z-0718-2025Class IIFESS-MB PACK-LF Convenience kit, SKU DYNJ0888159I. Convenience kits used for various...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-0717-2025Class IIMAJOR NEURO PACK-LF Convenience kit, SKU DYNJ0578916X. Convenience kits used for various...MEDLINE INDUSTRIES, LP - NorthfieldOES
Z-0733-2025Class II20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures.Abbott VascularMAV
Z-0732-2025Class II20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular...Abbott VascularMAV
Z-0731-2025Class II20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular...Abbott VascularMAV
Z-0730-2025Class II20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction...Abbott VascularMAV
Z-0987-2025Class IIMerlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which...Abbott MedicalMOM
Z-0652-2025Class IIChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device...Abbott MedicalONB
Z-0621-2025Class IIBD BBL Sensi Disc Ampicillin 2 g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 g...Becton Dickinson & CoJTN
Z-0838-2025Class IINOA Medical Industries Behavioral Health Hospital bed side rails, Product number...Noa Medical IndustriesIKX
Z-0616-2025Class IIGE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80662DA: China...GE Healthcare (China) Co., Ltd.JAK
Z-0615-2025Class IIGE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA: China...GE Healthcare (China) Co., Ltd.JAK
Z-0614-2025Class IIGE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80212DA: EU...GE Healthcare (China) Co., Ltd.JAK
Z-0613-2025Class IIGE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B79632DA: EU: RT...GE Healthcare (China) Co., Ltd.JAK
Z-0612-2025Class IIGE Healthcare Revolution Maxima Select, Model Number, 6670000-55; X-ray/computed...GE Healthcare (China) Co., Ltd.JAK
Z-0611-2025Class IIGE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed tomography...GE Healthcare (China) Co., Ltd.JAK
Z-0610-2025Class IIGE Healthcare Revolution Maxima, Model Numbers: 1) 6665000-2, 2) 6670000-2...GE Healthcare (China) Co., Ltd.JAK
Z-0609-2025Class IIGE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009...GE Healthcare (China) Co., Ltd.JAK
Z-0608-2025Class IIGE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography systemGE Healthcare (China) Co., Ltd.JAK
Z-0607-2025Class IIGE Healthcare Revolution Eagle, Model Number 5849504-3, X-ray/computed tomography systemGE Healthcare (China) Co., Ltd.JAK
Z-0606-2025Class IIGE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed...GE Healthcare (China) Co., Ltd.JAK
Z-0605-2025Class IIGE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography...GE Healthcare (China) Co., Ltd.JAK
Z-0604-2025Class IIGE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systemsGE Healthcare (China) Co., Ltd.JAK
Z-0603-2025Class IIGE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systemsGE Healthcare (China) Co., Ltd.JAK
Z-0602-2025Class IIGE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography systemGE Healthcare (China) Co., Ltd.JAK
Z-0601-2025Class IIGE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography systemsGE Healthcare (China) Co., Ltd.JAK
Z-0600-2025Class IIGE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems...GE Healthcare (China) Co., Ltd.JAK
Z-0663-2025Class IIMicroscissor Tip (Disposable); Microline Catalog #: 3122.Microline Surgical, IncGEI
Z-0507-2025Class IIV.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C. Ulta Negative...KCI USA, Inc.OMP
Z-0750-2025Class IIBYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner...Straight Smile, LLCNXC
Z-0548-2025Class IIST SENSE Breast Dx CoilPhilips North America LLCMOS
Z-0547-2025Class IIST SENSE Breast CoilPhilips North America LLCMOS
Z-0546-2025Class IISENSE Breast Coil 3.0T 7chPhilips North America LLCMOS
Z-0545-2025Class IISENSE Breast CoilPhilips North America LLCMOS
Z-0544-2025Class IIMammotrak Interventional Coil 3.0TPhilips North America LLCMOS
Z-0543-2025Class IIMammotrak Diagnostic Coil 3.0TPhilips North America LLCMOS
Z-0542-2025Class IIMammotrak Interventional Coil 1.5TPhilips North America LLCMOS
Z-0541-2025Class IIMammotrak Diagnostic Coil 1.5TPhilips North America LLCMOS
Z-0540-2025Class IIdS Breast 7ch 3.0TPhilips North America LLCMOS
Z-0539-2025Class IIdS Breast 7ch 1.5TPhilips North America LLCMOS
Z-0538-2025Class IIdS Breast 16ch 3.0TPhilips North America LLCMOS
Z-0537-2025Class IIdS Breast 16ch 1.5TPhilips North America LLCMOS
Z-0536-2025Class IIAchieva TX Interventional Coil 3.0TPhilips North America LLCMOS
Z-0597-2025Class IIAtellica CI Analyzer. Catalog Numbers: 10947347.Siemens Healthcare Diagnostics Inc.JJE
Z-0749-2025Class IIFACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181Becton, Dickinson and Company, BD BiosciencesOYE
Z-0748-2025Class IIFACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787 The K170974...Becton, Dickinson and Company, BD BiosciencesOYE
Z-0747-2025Class IIFACSLyric 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770 The K170974...Becton, Dickinson and Company, BD BiosciencesOYE
Z-0746-2025Class IIDevice Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, UDI...Becton, Dickinson and Company, BD BiosciencesOYE
Z-0745-2025Class IIFACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD FACSLyric"...Becton, Dickinson and Company, BD BiosciencesOYE