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 117 of 1190
FDA device recalls, page 117 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0157-2025Class IIMedline brand medical procedure convenience kits, labeled as: a) KIT LINE INSERTION...MEDLINE INDUSTRIES, LP - NorthfieldOFF
Z-0156-2025Class IIMedline brand, medical procedure convenience kits, labeled as: a) CUH OPEN HEART A B C...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-0155-2025Class IIMedline brand, medical procedure convenience kits, labeled as: a) RADIOLOGY LP TRAY...MEDLINE INDUSTRIES, LP - NorthfieldOES
Z-0154-2025Class IIMedline brand, medical procedure convenience kits, labeled as: a) SET UP PACK, REF...MEDLINE INDUSTRIES, LP - NorthfieldOEQ
Z-0153-2025Class IIMedline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDURE PACK, REF...MEDLINE INDUSTRIES, LP - NorthfieldOFT
Z-0152-2025Class IIMedline CV ANESTHESIA - ROOM SET UP, REF DYNJ905503F; medical procedure convenience kitMEDLINE INDUSTRIES, LP - NorthfieldCAI
Z-0151-2025Class IICenturion OB TRAY, REF MNS13965A; medical procedure convenience kitMEDLINE INDUSTRIES, LP - NorthfieldOKV
Z-0150-2025Class IICenturion brand, medical procedure convenience kits, labeled as: a) FLOOR - UMBILICAL...MEDLINE INDUSTRIES, LP - NorthfieldLRP
Z-0149-2025Class IICenturion EP LAB INSTRUMENT KIT, REF MNS10480; medical procedure convenience kitMEDLINE INDUSTRIES, LP - NorthfieldKDD
Z-0148-2025Class IICenturion PEDIATRIC/ADULT TRACHEOSTOMY T, REF TC7895; medical procedure convenience kitMEDLINE INDUSTRIES, LP - NorthfieldOGR
Z-0371-2025Class IIThe EVSRF catheter is a sterile, single-use disposable medical device for endovenous...Bard Peripheral Vascular IncGEI
Z-0090-2025Class IILeica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 14047033518, b)...Leica Biosystems Nussloch GmbHIDP
Z-0089-2025Class IILeica Biosystems Cryostat Model Number CM1950, Material Numbers: a) 14047742467, b)...Leica Biosystems Nussloch GmbHIDP
Z-0088-2025Class IILeica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b)...Leica Biosystems Nussloch GmbHIDP
Z-0087-2025Class IILeica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131148, b)...Leica Biosystems Nussloch GmbHIDP
Z-0086-2025Class IILeica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510C002, b)...Leica Biosystems Nussloch GmbHIDP
Z-0085-2025Class IILeica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing...Leica Biosystems Nussloch GmbHIDP
Z-0023-2025Class IITriathlon Universal TS Baseplate Size 2 - A single use sterile implantable device...Howmedica Osteonics CorpJWH
Z-0260-2025Class IIIProduct Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap...TRACKX TECHNOLOGY Inc.OWB
Z-0133-2025Class II(1) Centurion Sterile CirClamp, Reorder #200CR; (2) Centurion CirClamp with 1.1cm Bell...MEDLINE INDUSTRIES, LP - NorthfieldHFX
Z-3205-2024Class IISmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cross-sectional...Philips North America LLCLNH
Z-3204-2024Class IISmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obtain...Philips North America LLCLNH
Z-3203-2024Class IISmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cross-sectional...Philips North America LLCLNH
Z-3202-2024Class IIMR 7700 -For use as a diagnostic device to obtain cross-sectional images, spectroscopic...Philips North America LLCLNH
Z-3201-2024Class IIMR 5300 - For use as a diagnostic device to obtain cross-sectional images, spectroscopic...Philips North America LLCLNH
Z-3200-2024Class IIIngenia Elition X- For use as a diagnostic device to obtain cross-sectional images...Philips North America LLCLNH
Z-3199-2024Class IIIngenia Elition S -For use as a diagnostic device to obtain cross-sectional images...Philips North America LLCLNH
Z-3198-2024Class IIIngenia Ambition X - For use as a diagnostic device to obtain cross-sectional images...Philips North America LLCLNH
Z-3197-2024Class IIIngenia Ambition S - For use as a diagnostic device to obtain cross-sectional images...Philips North America LLCLNH
Z-3196-2024Class IIIngenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional images...Philips North America LLCLNH
Z-3195-2024Class IIIngenia 3.0T - For use as a diagnostic device to obtain cross-sectional images...Philips North America LLCLNH
Z-3194-2024Class IIIngenia 1.5T -For use as a diagnostic device to obtain cross-sectional images...Philips North America LLCLNH
Z-3193-2024Class IIEvolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectional images...Philips North America LLCLNH
Z-0048-2025Class IGE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal...GE HealthcareFMZ
Z-0047-2025Class IGE Heathcare Giraffe OmniBed; neo natal incubatorGE HealthcareFMZ
Z-0920-2025Class IIImplant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518NS.I.N. Implant System LtdaDZE
Z-0230-2025Class IILIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o...Physio Control, Inc.MKJ
Z-0062-2025Class IIMelrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe...Merit Medical Systems, Inc.DXT
Z-0061-2025Class IIMonarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal...Merit Medical Systems, Inc.DXT
Z-0060-2025Class IIMonarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool...Merit Medical Systems, Inc.DXT
Z-0059-2025Class IIMonarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool...Merit Medical Systems, Inc.DXT
Z-0058-2025Class IIMonarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion...Merit Medical Systems, Inc.DXT
Z-0057-2025Class IIMonarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe...Merit Medical Systems, Inc.DXT
Z-0209-2025Class IIPredict+ is a data-driven, clinical decision support tool that uses machine learning to...Blue OrthoN/A
Z-0034-2025Class IIMEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.MEDLINE INDUSTRIES, LP - NorthfieldDXN
Z-0033-2025Class IIMedline Automatic Digital Blood Pressure Unit, Ref Mds1001u.MEDLINE INDUSTRIES, LP - NorthfieldDXN
Z-0032-2025Class IIMedline Automatic Digital Blood Pressure Unit, Ref Mds1001MEDLINE INDUSTRIES, LP - NorthfieldDXN
Z-0021-2025Class IIThe Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness...Stryker Corp.QJP
Z-0004-2025Class INeo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency...Mercury Medical Enterprises, LLCBTL
Z-3249-2024Class IIIntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061)...Philips North America LLCMHX