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 22 of 1187
FDA device recalls, page 22 of 1187
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1958-2026Class IIPhilips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2...Philips North America LLCLNH
Z-1957-2026Class IIPhilips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.Philips North America LLCLNH
Z-1956-2026Class IIPhilips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2...Philips North America LLCLNH
Z-1955-2026Class IIPhilips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF)...Philips North America LLCLNH
Z-1954-2026Class IIPhilips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF)...Philips North America LLCLNH
Z-1953-2026Class IIPhilips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.Philips North America LLCLNH
Z-1952-2026Class IIPhilips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF)...Philips North America LLCLNH
Z-1951-2026Class IIPhilips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2...Philips North America LLCLNH
Z-2165-2026Class IIBrand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+...Dexcom, Inc.QBJ
Z-2164-2026Class IIBrand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM...Dexcom, Inc.QBJ
Z-2163-2026Class IIBrand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM...Dexcom, Inc.QBJ
Z-2230-2026Class IIHalyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772...O&M Halyard, Inc.LZC
Z-2332-2026Class IIBrand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Product Name: SPORETRAQ...HF Acquisition Co. LLCFRC
Z-2331-2026Class IIBrand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ...HF Acquisition Co. LLCFRC
Z-2065-2026Class IILIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241...Physio Control, Inc.MKJ
Z-2161-2026Class IILUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code...Jolife ABDRM
Z-2260-2026Class IIMedline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ21627PMEDLINE INDUSTRIES, LP - NorthfieldOJK
Z-2237-2026Class IMedline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as...MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-2236-2026Class IMedline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-2235-2026Class IMedline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as...MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-2234-2026Class IMedline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as...MEDLINE INDUSTRIES, LP - NorthfieldOGJ
Z-2233-2026Class IMedline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as...MEDLINE INDUSTRIES, LP - NorthfieldOGE
Z-2232-2026Class IMedline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as...MEDLINE INDUSTRIES, LP - NorthfieldOFT
Z-2231-2026Class IMedline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as...MEDLINE INDUSTRIES, LP - NorthfieldCAI
Z-2159-2026Class INextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX...Arrow International LLC (subsidiary of Teleflex Incorporated)MSD
Z-2158-2026Class ICannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP...Arrow International LLC (subsidiary of Teleflex Incorporated)MSD
Z-2157-2026Class IArrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI...Arrow International LLC (subsidiary of Teleflex Incorporated)MSD
Z-2173-2026Class IICodman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID...Integra LifeSciences CorporationJXG
Z-2156-2026Class IArrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-IArrow International LLC (subsidiary of Teleflex Incorporated)MSD
Z-2199-2026Class IIMedtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETERStryker Sustainability SolutionsNLH
Z-2198-2026Class IIDaig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETERStryker Sustainability SolutionsNLH
Z-2197-2026Class IIDaig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETERStryker Sustainability SolutionsNLH
Z-2196-2026Class IIDaig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETERStryker Sustainability SolutionsNLH
Z-2195-2026Class IIDaig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETERStryker Sustainability SolutionsNLH
Z-2194-2026Class IIDaig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETERStryker Sustainability SolutionsNLH
Z-2193-2026Class IIDaig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETERStryker Sustainability SolutionsNLH
Z-2192-2026Class IIDaig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETERStryker Sustainability SolutionsNLH
Z-2191-2026Class IIDaig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETERStryker Sustainability SolutionsNLH
Z-2190-2026Class IIDaig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETERStryker Sustainability SolutionsNLH
Z-2189-2026Class IIDaig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETERStryker Sustainability SolutionsNLH
Z-2188-2026Class IIDaig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETERStryker Sustainability SolutionsNLH
Z-2187-2026Class IIDaig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETERStryker Sustainability SolutionsNLH
Z-2186-2026Class IIDaig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETERStryker Sustainability SolutionsNLH
Z-2185-2026Class IICS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY...Stryker Sustainability SolutionsNLH
Z-2184-2026Class IICS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY...Stryker Sustainability SolutionsNLH
Z-2183-2026Class IIBW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETERStryker Sustainability SolutionsNLH
Z-2182-2026Class IIBARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETERStryker Sustainability SolutionsNLH
Z-2181-2026Class IIBARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY...Stryker Sustainability SolutionsNLH
Z-2180-2026Class IIBARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETERStryker Sustainability SolutionsNLH
Z-2179-2026Class IIBARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETERStryker Sustainability SolutionsNLH