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

59,336 records, page 3 of 1187
FDA device recalls, page 3 of 1187
Recall numberClassProductRecalling firmProduct codeInitiated
Z-3123-2026Class IMedline Convenience Kits: 1) PORT ACCESS KIT UNIV OF ALA, Catalog Number: DYKM1414; 2)...Medline Industries, LPOFF
Z-3122-2026Class IMedline Convenience Kits: 1) OPEN HEART ADULT, Catalog Number: CDS840396Y; 2) FULL LINE...Medline Industries, LPOEZ
Z-3121-2026Class IMedline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199AMedline Industries, LPCAI
Z-3140-2026Class IINCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing...CooperSurgical, Inc.BZD
Z-3139-2026Class IINCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing...CooperSurgical, Inc.BZD
Z-3066-2026Class IIBaxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSLBaxter Healthcare CorporationFRN
Z-3065-2026Class IIBaxter Novum IQ Syringe Pump, Model Number 40800BAXUSBaxter Healthcare CorporationFRN
Z-3250-2026Class IIForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 00690103210927 The...Becton, Dickinson and CompanyMUD
Z-3294-2026Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary...American Contract Systems IncOJF
Z-3293-2026Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary...American Contract Systems IncOEZ
Z-3292-2026Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary...American Contract Systems IncFDE
Z-3154-2026Class IHaylard UNIV IMAGING BIOPSY TRUCUSTOM; Model/Item Number (Kit): VARV042-03;AVID Medical, Inc.OES
Z-3153-2026Class IHaylard BASIC BIOPSY TRAY; Model/Item Number (Kit): PM415;AVID Medical, Inc.LRO
Z-3152-2026Class IHaylard CONTINUOUS NERVE BLOCK TRAY; Model/Item Number (Kit): BMCN001-05;AVID Medical, Inc.OGD
Z-3151-2026Class IHaylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02;AVID Medical, Inc.OGD
Z-3269-2026Class IIMedline Convenience Kits: 1) ANTERIOR SPINE PACK, Catalog Number: DYNJT10197; 2)...Medline Industries, LPOJH
Z-3268-2026Class IIMedline Convenience Kits: 1) MAJOR NEURO VCH, Catalog Number: DYNJ39218I; 2) NEURO...Medline Industries, LPOJG
Z-3267-2026Class IIMedline Convenience Kits: 1) MFC CRANIOTOMY PACK, Catalog Number: DYNJT8784; 2) SLUH...Medline Industries, LPLRO
Z-3266-2026Class IIMedline Convenience Kits: 1) MAJOR PACK, Catalog Number: DYNJ81325AMedline Industries, LPFDE
Z-3265-2026Class IIMedline Convenience Kits: 1) PEDS SINUS PACK, Catalog Number: DYNJ02516G; 2) SINUS...Medline Industries, LPOGR
Z-3230-2026Class IIMedline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK...Medline Industries, LPOGR
Z-3229-2026Class IIMedline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK...Medline Industries, LPLRO
Z-3255-2026Class IIPresource Convenience Kits: 1) KIT, USGPIV , Catalog Number: PVMHIVMHD...Cardinal Health 200, LLCOWL
Z-3254-2026Class IIPresource Convenience Kits: 1) KIT, PRE OP , Catalog Number...Cardinal Health 200, LLCLRP
Z-2985-2026Class IDuoGlide Short-Term Straight Dialysis Catheter, REF: 5625150; DuoGlide Short-Term...Bard Access Systems, Inc.MPB
Z-3087-2026Class II5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8Fresenius Medical Care Renal Therapies Group, LLCKOC
Z-3086-2026Class II5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3CFresenius Medical Care Renal Therapies Group, LLCKOC
Z-3085-2026Class II5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3Fresenius Medical Care Renal Therapies Group, LLCKOC
Z-3084-2026Class II5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6Fresenius Medical Care Renal Therapies Group, LLCKOC
Z-3305-2026Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA...Merit Medical Systems, Inc.KRD
Z-2984-2026Class IPower-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605150; Power-Trialysis...Bard Access Systems, Inc.MPB
Z-3043-2026Class IIPhilips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64...Philips North America LLCJAK
Z-3042-2026Class IIPhilips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China...Philips North America LLCJAK
Z-3041-2026Class IIPhilips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT...Philips North America LLCJAK
Z-3040-2026Class IIPhilips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP...Philips North America LLCJAK
Z-3249-2026Class IIPhilips EPIQ Elite Diagnostic Ultrasound System Model # 795234Philips Ultrasound, LLCIYN
Z-3224-2026Class IIPowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model...Maquet SASFSY
Z-3113-2026Class IIGetinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1...Atrium Medical CorporationGBZ
Z-3112-2026Class IIGetinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case; Size(Model Number): 1...Atrium Medical CorporationGBZ
Z-3111-2026Class IIGetinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1...Atrium Medical CorporationGBZ
Z-3176-2026Class IIHappiest Baby, Inc. SNOO Sleep Sack, X-Large Model/Catalog Number...Happiest Baby, IncQTG
Z-3175-2026Class IIHappiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number...Happiest Baby, IncQTG
Z-3276-2026Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VAVolcano CorpIYO
Z-3090-2026Class IBravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule...Given Imaging Ltd.FFT
Z-3110-2026Class IIProduct Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that...Lutronic CorporationGEX
Z-3034-2026Class IIORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000...IMRIS Imaging, Inc.KXJ
Z-3033-2026Class IIORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned...IMRIS Imaging, Inc.FQO
Z-3215-2026Class IIBrand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex...Heidelberg Engineering GmbHOBO
Z-3083-2026Class IILUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS...Boston Scientific CorporationMXD
Z-3082-2026Class IILUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS...Boston Scientific CorporationMXD