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 152 of 1190
FDA device recalls, page 152 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1773-2024Class IIDURAMAX STACKED TIP 32 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining...Boston Scientific CorporationMSD
Z-1772-2024Class IIDURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 5-UP PG- Indicated for use in attaining...Boston Scientific CorporationMSD
Z-1771-2024Class IIDURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining...Boston Scientific CorporationMSD
Z-1770-2024Class IIDURAMAX STACKED TIP 32CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining...Boston Scientific CorporationMSD
Z-1769-2024Class IIDURAMAX STACKED TIP 28CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining...Boston Scientific CorporationMSD
Z-1768-2024Class IIDURAMAX STACKED TIP 28CM STR. BASIC KIT, 1-UP PG- Indicated for use in attaining...Boston Scientific CorporationMSD
Z-1767-2024Class IIDURAMAX STACKED TIP 24CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining...Boston Scientific CorporationMSD
Z-1766-2024Class IIDURAMAX STACKED TIP 24CM STR. BASIC KIT, 1-UP PG Product Number: H787103028031Boston Scientific CorporationMSD
Z-1765-2024Class IIDURAFLOW 2, 28CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term...Boston Scientific CorporationMSD
Z-1764-2024Class IIDURAFLOW 2, 24CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term...Boston Scientific CorporationMSD
Z-1763-2024Class IIDURAFLOW 2, 55CM STRAIGHT BASIC KIT PG- Indicated for use in attaining Long-Term...Boston Scientific CorporationMSD
Z-1762-2024Class IIDURAFLOW 2, 32CM STRAIGHT BASIC KIT PG-Indicated for use in attaining Long-Term...Boston Scientific CorporationMSD
Z-1761-2024Class IIDURAFLOW 2, 28CM STRAIGHT BASIC KIT, 1 per Bx PG-Indicated for use in attaining...Boston Scientific CorporationMSD
Z-1760-2024Class IIDURAFLOW 2, 24CM STRAIGHT BASIC KIT -Indicated for use in attaining Long-Term vascular...Boston Scientific CorporationMSD
Z-1783-2024Class IIGE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systemsGE Medical Systems SCSOWB
Z-1782-2024Class IIGE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systemsGE Medical Systems SCSOWB
Z-1781-2024Class IIGE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systemsGE Medical Systems SCSOWB
Z-1780-2024Class IIGE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systemsGE Medical Systems SCSOWB
Z-1779-2024Class IIGE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systemsGE Medical Systems SCSOWB
Z-1778-2024Class IIGE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systemsGE Medical Systems SCSOWB
Z-1777-2024Class IIGE Healthcare Innova IGS 5, computed tomography x-ray systemGE Medical Systems SCSOWB
Z-1615-2024Class IILightStrike Blackout Curtains, Part numbers; 610-00008, 610-00009, 610-00019, 610-00020...XENEX Disinfection Services Inc.QXJ
Z-1689-2024Class IIBaxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal...Baxter Healthcare CorporationMCN
Z-1635-2024Class IIPalindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Symmetrical...Medtronic, Inc.MSD
Z-1634-2024Class IIPalindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm...Medtronic, Inc.MSD
Z-1758-2024Class IIPERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TLF-DS 45...Spineart SANKB
Z-1606-2024Class IIVarious Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang...Alcon LaboratoriesLRO
Z-1397-2024Class IElekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm...Elekta Instrument ABHAW
Z-2232-2024Class IINon-sterile convenience kits: a. Medline CC Drawer 4 IV Circulation, Pack #ACC010254B...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-2231-2024Class IINon-sterile convenience kits: Medline Open Heart CDS, Pack #CDS981759C, containing a...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-2230-2024Class IINon-sterile convenience kits: a. Medline Difficult Airway Tray W/O Cook, Pack...MEDLINE INDUSTRIES, LP - NorthfieldCAI
Z-2229-2024Class IINonsterile convenience kits: a. Medline Delivery, Pack #DYNJ901130I, containing a Pure...MEDLINE INDUSTRIES, LP - NorthfieldMLS
Z-2228-2024Class IISterile convenience kits: a. Medline Retrograde PK-22025203-LF, Pack #DYNJ47873K...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-2227-2024Class IISterile convenience kit: Medline Birthing Room Pack, Pack #DYNJ38429D, containing a Pure...MEDLINE INDUSTRIES, LP - NorthfieldMLS
Z-2226-2024Class IISterile surgical convenience kit: Medline Neuro IR Pack, Pack #DYNJ56073C, containing a...MEDLINE INDUSTRIES, LP - NorthfieldOJG
Z-2225-2024Class IISterile surgical convenience kit: Medline Retrograde PK-22025203-LF, Pack #DYNJ47873L...MEDLINE INDUSTRIES, LP - NorthfieldFDE
Z-1875-2024Class IIPrelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX...Merit Medical Systems, Inc.DYB
Z-1874-2024Class IIPrelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX...Merit Medical Systems, Inc.DYB
Z-1694-2024Class IIKeller Funnel 2, REF: HA-001, STERILEEO, Rx Only,AllerganKDD
Z-1464-2024Class IVITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial...bioMerieux, Inc.LON
Z-2224-2024Class IISterile surgical convenience kits: a. Medline Cath Lab Special Procedure, Pack...MEDLINE INDUSTRIES, LP - NorthfieldOES
Z-1755-2024Class IIJohnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber...Advanced Medical Optics, Inc.HQC
Z-1733-2024Class IBioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites...Hologic, Inc.NEU
Z-1607-2024Class IIVanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082...Zimmer GmbHMBH
Z-1688-2024Class IIBrand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number...E.M.S. - Electro Medical Systems SAELC
Z-1687-2024Class IIBrand Name: WATER BOTTLE Product Name: WATER BOTTLE Model/Catalog Number: EG-121 Software...E.M.S. - Electro Medical Systems SAELC
Z-1686-2024Class IIBrand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number...E.M.S. - Electro Medical Systems SAELC
Z-1549-2024Class IIAtellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and...Siemens Healthcare Diagnostics Inc.JIY
Z-1518-2024Class IIPatient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098Intuitive Surgical, Inc.NAY
Z-1807-2024Class IINamic FLUID DELIVERY SET, REF 91300040MEDLINE INDUSTRIES, LP - NorthfieldFPA