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 146 of 1190
FDA device recalls, page 146 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2767-2024Class IICenturion procedure kits, labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-2766-2024Class IICenturion procedure kits labeled as: 1) BIOPSY KIT, Pack Number DYNDA1466A; 2) BIOPSY...MEDLINE INDUSTRIES, LP - NorthfieldOGR
Z-2516-2024Class IICenturion procedure kits labeled as: 1) CVC INSERT BUNDLE 16CM, Pack Number ECVC3260...MEDLINE INDUSTRIES, LP - NorthfieldLRP
Z-2515-2024Class IICenturion procedure kits labeled as NEURO ANGIO PACK, Pack Number DYNDA1431AMEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-2444-2024Class IMedline procedure kits labeled as: 1) WMC HYBRID OR PACK PART 1 , Pack Number...MEDLINE INDUSTRIES, LP - NorthfieldOES
Z-2443-2024Class IMedline procedure kits labeled as: 1) NEPHROLOGY PACK, Pack Number DYNJ59089...MEDLINE INDUSTRIES, LP - NorthfieldOGJ
Z-2442-2024Class IMedline procedure kits labeled as: 1) CONTINUOUS BLOCK, Pack Number DYNJRA0960C; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOFT
Z-2633-2024Class IIMedline procedure packs containing Shenli syringes, labeled as follows: NEURO ANGIO...MEDLINE INDUSTRIES, LP - NorthfieldOIB
Z-2632-2024Class IIMedline procedure packs containing Shenli syringes, labeled as follows: 1) NEURO ANGIO...MEDLINE INDUSTRIES, LP - NorthfieldLRP
Z-2631-2024Class IIMedline procedure packs containing Shenli syringes, labeled as follows: 1) CVC DOUBLE...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-2630-2024Class IIMedline procedure packs containing Shenli syringes, labeled as follows: 1) DIALYSIS CATH...MEDLINE INDUSTRIES, LP - NorthfieldPEV
Z-2629-2024Class IIMedline procedure packs containing Shenli syringes, labeled as follows: 1) CVC INSERT...MEDLINE INDUSTRIES, LP - NorthfieldOFG
Z-2628-2024Class IISee RES descriptionMEDLINE INDUSTRIES, LP - NorthfieldOES
Z-2627-2024Class IIMedline procedure packs containing Shenli syringes, labeled as follows: 1) ANGIOGRAPHY...MEDLINE INDUSTRIES, LP - NorthfieldOEQ
Z-2626-2024Class IISee RES descriptionMEDLINE INDUSTRIES, LP - NorthfieldOGJ
Z-2625-2024Class IISee RES DescriptionMEDLINE INDUSTRIES, LP - NorthfieldOGE
Z-2624-2024Class IIsee RES for descriptionMEDLINE INDUSTRIES, LP - NorthfieldOFT
Z-2623-2024Class IIMedline procedure packs containing Shenli syringes, labeled as follows: 1) LOCAL PACK...MEDLINE INDUSTRIES, LP - NorthfieldOFQ
Z-1822-2024Class IINovalung sensor box is a component of the Novalung Console (F30000162)-Indicated for...Fresenius Medical Care Renal Therapies Group, LLCQJZ
Z-1730-2024Class IVyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The...Jaeger Medical GmbHBZC
Z-1820-2024Class IIHeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450PHeartSine Technologies LtdMKJ
Z-2128-2024Class IIBrand Name: MEDLINE Product Name: SYR 20ML/L PURPLE Model/Catalog Number: 91843 Product...Jiangsu Shenli Medical Production Co., Ltd.FMF
Z-2127-2024Class IIBrand Name: MEDLINE Product Name: SYR 10ML/L BLUE CONTRAST Model/Catalog Number...Jiangsu Shenli Medical Production Co., Ltd.FMF
Z-2126-2024Class IIBrand Name: MEDLINE Product Name: SYR 20ML/L WHITE HEP FLUSH Model/Catalog Number...Jiangsu Shenli Medical Production Co., Ltd.FMF
Z-2125-2024Class IIBrand Name: MEDLINE Product Name: SYR 20ML/L WHITE CONTRAST Model/Catalog Number...Jiangsu Shenli Medical Production Co., Ltd.FMF
Z-2124-2024Class IIBrand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205S-M Product...Jiangsu Shenli Medical Production Co., Ltd.FMF
Z-2123-2024Class IIBrand Name: GMAX Product Name: SYR 60ML/LL Blue syringe Model/Catalog Number...Jiangsu Shenli Medical Production Co., Ltd.FMF
Z-2122-2024Class IIBrand Name: GMAX Product Name: SYR 10ML/LL Blue syringe Model/Catalog Number...Jiangsu Shenli Medical Production Co., Ltd.FMF
Z-2121-2024Class IIBrand Name: GMAX Product Name: SYR 10ML Control syringe Model/Catalog Number...Jiangsu Shenli Medical Production Co., Ltd.FMF
Z-2120-2024Class IIBrand Name: GMAX Product Name: SYR 60ML/LS syringe Model/Catalog Number...Jiangsu Shenli Medical Production Co., Ltd.FMF
Z-2119-2024Class IIBrand Name: GMAX Product Name: SYR 20ML/LS syringe Model/Catalog Number...Jiangsu Shenli Medical Production Co., Ltd.FMF
Z-2118-2024Class IIBrand Name: GMAX Product Name: SYR 12ML/LS syringe Model/Catalog Number...Jiangsu Shenli Medical Production Co., Ltd.FMF
Z-2117-2024Class IIBrand Name: GMAX Product Name: SYR 10ML/LS syringe Model/Catalog Number...Jiangsu Shenli Medical Production Co., Ltd.FMF
Z-2116-2024Class IIBrand Name: GMAX Product Name: SYR 60ML/LL syringe Model/Catalog Number...Jiangsu Shenli Medical Production Co., Ltd.FMF
Z-2115-2024Class IIBrand Name: GMAX Product Name: SYR 35ML/LL syringe Model/Catalog Number...Jiangsu Shenli Medical Production Co., Ltd.FMF
Z-2114-2024Class IIBrand Name: GMAX Product Name: SYR 30ML/LL syringe Model/Catalog Number...Jiangsu Shenli Medical Production Co., Ltd.FMF
Z-2113-2024Class IIBrand Name: GMAX Product Name: SYR 20ML/LL syringe Model/Catalog Number...Jiangsu Shenli Medical Production Co., Ltd.FMF
Z-2112-2024Class IIBrand Name: GMAX Product Name: SYR 12ML/LL syringe Model/Catalog Number...Jiangsu Shenli Medical Production Co., Ltd.FMF
Z-2111-2024Class IIBrand Name: GMAX Product Name: SYR 10ML/LL syringe Model/Catalog Number...Jiangsu Shenli Medical Production Co., Ltd.FMF
Z-2110-2024Class IIBrand Name: GMAX Product Name: SYR 6ML/LL syringe Model/Catalog Number: TS2206L-M Product...Jiangsu Shenli Medical Production Co., Ltd.FMF
Z-2109-2024Class IIBrand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205L-M Product...Jiangsu Shenli Medical Production Co., Ltd.FMF
Z-2108-2024Class IIBrand Name: GMAX Product Name: SYR 3ML/LL syringe Model/Catalog Number: TS2203L-M Product...Jiangsu Shenli Medical Production Co., Ltd.FMF
Z-2107-2024Class IIBrand Name: Wolf Medical Product Name: 60 mL (cc) Luer Lock STERILE LATEX FREE NON...Jiangsu Shenli Medical Production Co., Ltd.FMF
Z-2106-2024Class IIBrand Name: Wolf Medical Product Name: 35 mL (cc) Luer Lock STERILE LATEX FREE NON...Jiangsu Shenli Medical Production Co., Ltd.FMF
Z-2105-2024Class IIBrand Name: Wolf Medical Product Name: 20 mL (cc) Luer Lock STERILE LATEX FREE NON...Jiangsu Shenli Medical Production Co., Ltd.FMF
Z-2104-2024Class IIBrand Name: Wolf Medical Product Name: 12 mL (cc) Luer Lock STERILE LATEX FREE NON...Jiangsu Shenli Medical Production Co., Ltd.FMF
Z-2103-2024Class IIBrand Name: Wolf Medical Product Name: 6 mL (cc) Luer Lock STERILE LATEX FREE NON...Jiangsu Shenli Medical Production Co., Ltd.FMF
Z-2102-2024Class IIBrand Name: Wolf Medical Product Name: 3 mL (cc) Luer Lock STERILE LATEX FREE NON...Jiangsu Shenli Medical Production Co., Ltd.FMF
Z-2101-2024Class IIBrand Name: Wolf Medical - WOLF-PAK Product Name: DISPOSABLE SYRINGE 1 mL (cc) Luer Lock...Jiangsu Shenli Medical Production Co., Ltd.FMF
Z-2100-2024Class IIBrand Name: MEDIGRATIVE Product Name: 100cc/ml disposable luer lock syringe Model/Catalog...Jiangsu Shenli Medical Production Co., Ltd.FMF