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 133 of 1190
FDA device recalls, page 133 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2566-2024Class IIVarious Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical...Merit Medical Systems, Inc.OEZ
Z-2565-2024Class IIVarious Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical...Merit Medical Systems, Inc.PPD
Z-2564-2024Class IIVarious Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical...Merit Medical Systems, Inc.OEZ
Z-2563-2024Class IIVarious Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical...Merit Medical Systems, Inc.OJA
Z-2562-2024Class IIVarious Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical...Merit Medical Systems, Inc.OEQ
Z-2561-2024Class IIVarious Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical...Merit Medical Systems, Inc.OJA
Z-2560-2024Class IIVarious Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical...Merit Medical Systems, Inc.OEQ
Z-2559-2024Class IIVarious Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical...Merit Medical Systems, Inc.ODY
Z-2558-2024Class IIVarious Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical...Merit Medical Systems, Inc.OEQ
Z-2408-2024Class IIProduct Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number...Canadian Hospital Specialties Ltd.GCJ
Z-2407-2024Class IISURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1963Ethicon SARLLMG
Z-2406-2024Class IISURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961Ethicon SARLLMG
Z-2557-2024Class IIVarious Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical...Merit Medical Systems, Inc.NWU
Z-2683-2024Class IIBIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143BioFire Diagnostics, LLCQDS
Z-2682-2024Class IIBIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144BioFire Diagnostics, LLCQDS
Z-3088-2024Class Ismiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect...Abbott MedicalBTO
Z-3087-2024Class Ismiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect...Abbott MedicalBTO
Z-3086-2024Class Ismiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) BLUSELECT...Abbott MedicalBTO
Z-2425-2024Class IIRX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox...Randox Laboratories, LimitedNDY
Z-2331-2024Class IIAURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator...Integra LifeSciences CorporationGWG
Z-2129-2024Class IIOMTech Desktop Laser EngraverRygel Advanced Machines d/b/a Omtech LaserRIM
Z-2455-2024Class IIDxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer...Beckman Coulter Mishima K.K.JJE
Z-2336-2024Class IISynergetics I Pack Injection Kit with Wire Speculum- Tray for use in Opthalmic...Microspecialties LLCKDD
Z-2335-2024Class IISynergetics I Pack Injection Kit Custom-Tray for use with Ophthalmic...Microspecialties LLCKDD
Z-2334-2024Class IISynergetics I-Pack Injection Kit with Drape -For use with Ophthalmic...Microspecialties LLCKDD
Z-2333-2024Class IISynergetics I Pack Injection Kit- Tray for use with Ophthalmic injections Model/Catalog...Microspecialties LLCKDD
Z-2165-2024Class ISENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging...Philips North America LLCMOS
Z-2164-2024Class ISENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in...Philips North America LLCMOS
Z-2163-2024Class ISENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in...Philips North America LLCMOS
Z-2357-2024Class IIBrand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog...SeaSpine Orthopedics CorporationHWJ
Z-2414-2024Class IIDxl 9000 Access Immunoassay Analyzer, Catalog #C11137.Siemens Healthcare Diagnostics Inc.JJE
Z-2263-2024Class IIZyno Medical Z800, Z800F, Z800W, and Z800WF Infusion PumpsZyno Medical LLC.FRN
Z-2315-2024Class IIiLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical Light); b)...Baxter Healthcare CorporationFTD
Z-2314-2024Class IITrulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b)...Baxter Healthcare CorporationFTD
Z-2313-2024Class IIVidiaPort carrying arm, mount for auxiliary products, model numbers: a) 4028110...Baxter Healthcare CorporationKQM
Z-2353-2024Class IIQIAcube Connect MDx - IVD Instrument designed to perform automated isolation and...QiagenJJH
Z-2323-2024Class IIWelch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150A-1ENB...Baxter Healthcare CorporationDPS
Z-2347-2024Class IIRTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model...Fresenius Medical Care Renal Therapies Group, LLCKDI
Z-2346-2024Class IIRTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model...Fresenius Medical Care Renal Therapies Group, LLCKDI
Z-2345-2024Class IIRTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number...Fresenius Medical Care Renal Therapies Group, LLCKDI
Z-2344-2024Class IIRTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model...Fresenius Medical Care Renal Therapies Group, LLCKDI
Z-2343-2024Class II190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model...Fresenius Medical Care Renal Therapies Group, LLCKDI
Z-2342-2024Class II191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model...Fresenius Medical Care Renal Therapies Group, LLCKDI
Z-2341-2024Class II190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number...Fresenius Medical Care Renal Therapies Group, LLCKDI
Z-2643-2024Class IITransfer Device, REF 2008S. Packaged on a form, fill and seal machine with a poly/Tyvek...Microtek Medical LLCKPE
Z-2642-2024Class IIVial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a poly/Tyvek...Microtek Medical LLCKPE
Z-2641-2024Class IIBottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a poly/Tyvek...Microtek Medical LLCKPE
Z-2640-2024Class IIBag Decanter II, REF 2002S. Packaged on a form, fill and seal machine with a poly/Tyvek...Microtek Medical LLCKPE
Z-2639-2024Class IIC-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a...Microtek Medical LLCKPE
Z-2221-2024Class IIEndoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection...Aspen Surgical Products, Inc.GCJ