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 165 of 1190
FDA device recalls, page 165 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1146-2024Class IIHENRY SCHEIN CRITERION EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)AMD Medicom Inc.FXX
Z-0976-2024Class IIFLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap...G & H Wire CompanyECI
Z-1006-2024Class IIArticle No. NA6050411, Valiant PhD No. 1 EconoIvoclar Vivadent, Inc.EJJ
Z-0845-2024Class IISofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 SOFSILK* 4-0...Medtronic, Inc.GAP
Z-0844-2024Class IISurgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41...Medtronic, Inc.GAR
Z-0969-2024Class IIMEDLINE BLOOD CULTURE TRAY ADULT, Reorder Number DYNDH1194AMEDLINE INDUSTRIES, LP - NorthfieldOIB
Z-0968-2024Class IIMEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1622CMEDLINE INDUSTRIES, LP - NorthfieldOIB
Z-0967-2024Class IIMEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1723MEDLINE INDUSTRIES, LP - NorthfieldOIB
Z-0966-2024Class IIMEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1626BMEDLINE INDUSTRIES, LP - NorthfieldOIB
Z-0965-2024Class IIMEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1714AMEDLINE INDUSTRIES, LP - NorthfieldOIB
Z-0964-2024Class IIMEDLINE BLOOD CULTURE BOTTLE KIT, Reorder Number DYNDH1738AMEDLINE INDUSTRIES, LP - NorthfieldOIB
Z-0963-2024Class IIMEDLINE ADULT BLOOD CULTURE KIT, Reorder Number DYNDH1694AMEDLINE INDUSTRIES, LP - NorthfieldOIB
Z-0868-2024Class IITERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600Terumo Cardiovascular Systems CorporationNOY
Z-0756-2024Class IICardinal Health Suction Canister Liner, MEDI-VAC CRD 1000 mL Suction Canister Liner Kit...Medtronic, Inc.GCX
Z-0755-2024Class IICardinal Health MEDI-VAC CRD Suction Canister Liner, 1000 mL Suction Canister Liner Kit...Medtronic, Inc.GCX
Z-0754-2024Class IICardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-510Medtronic, Inc.GCX
Z-1183-2024Class IIZyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion...Zyno Medical LLC.FRN
Z-1180-2024Class IIThese wipes are saturated with 0.65% bleach solution. These wipes are antimicrobial...MEDLINE INDUSTRIES, LP - NorthfieldLRJ
Z-0806-2024Class IIBard Suction Connector with ENFit, REF EN0066000C.R. Bard IncKNT
Z-0805-2024Class IIBard Nasogastric Sump Tube and PreVent Anti-Reflux Filter and Lopez Valve with ENFit...C.R. Bard IncFEG
Z-0804-2024Class IIBard Nasogastric Sump Tube and PreVent Filter and Lopez Valve with ENFit, 16Fr., 48in...C.R. Bard IncFEG
Z-0803-2024Class IIBard Nasogastric Sump Tube and PreVent Filter and Lopez Valve with ENFit, 14Fr., 48in...C.R. Bard IncFEG
Z-0802-2024Class IIBard Nasogastric Sump Tube and PreVent Anti-Reflux Filter and Lopez Valve with ENFit...C.R. Bard IncFEG
Z-0801-2024Class IIBard Lopez Valve with ENFit, REF EN0056000C.R. Bard IncKNT
Z-0800-2024Class IIBard Nasogastric Sump Tube with PreVent Anti-Reflux Filter with ENFit, 18Fr., 48in Long...C.R. Bard IncFEG
Z-0799-2024Class IIBard Nasogastric Sump Tube with PreVent Anti-Reflux Filter with ENFit, 16Fr., 48in Long...C.R. Bard IncFEG
Z-0798-2024Class IIBard Nasogastric Sump Tube with PreVent Anti-Reflux Filter with ENFit, 14Fr., 48in Long...C.R. Bard IncFEG
Z-0797-2024Class IIBard Nasogastric Sump Tube with PreVent Anti-Reflux Filter with ENFit", 12Fr., 48in Long...C.R. Bard IncFEG
Z-0796-2024Class IIBard Nasogastric Sump Tube with PreVent Anti-Reflux Filter with ENFit, 10Fr., 36in Long...C.R. Bard IncFEG
Z-0795-2024Class IIBard PreVent Anti-Reflux Filter with ENFit, REF EN0046000C.R. Bard IncFEG
Z-0794-2024Class IIBard Nasogastric Sump Tube with ENFit, 18Fr., 48in Long, REF EN0042180C.R. Bard IncBSS
Z-0793-2024Class IIBard Nasogastric Sump Tube with ENFit, 16Fr., 48in Long, REF EN0042160C.R. Bard IncBSS
Z-0792-2024Class IIBard Nasogastric Sump Tube with ENFit, 14Fr., 48in Long, REF EN0042140C.R. Bard IncBSS
Z-0791-2024Class IIBard Nasogastric Sump Tube with ENFit, 12Fr., 48in Long, REF EN0042120C.R. Bard IncBSS
Z-0979-2024Class IIBarco MDSC-8527 NXF, Part Number K9352421Barco N.V.KQM
Z-1089-2024Class IIglobal Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100...CooperSurgical, Inc.MQL
Z-0790-2024Class IIBard Nasogastric Sump Tube with ENFit, 10Fr., 36in Long, REF EN0042100C.R. Bard IncBSS
Z-1218-2024Class IIAcu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045...Acumed LLCHRS
Z-1153-2024Class IIEndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.Boston Scientific CorporationPIF
Z-1543-2024Class IISmiths Medical Medfusion Guide Barrel Clamp, Item number G6000716Abbott MedicalMRZ
Z-1542-2024Class IISmiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion Model...Abbott MedicalFRN
Z-1541-2024Class IISmiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b)...Abbott MedicalFRN
Z-1540-2024Class IISmiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b)...Abbott MedicalFRN
Z-0864-2024Class Ismiths medical Medfusion Model 4000 syringe pumpAbbott MedicalFRN
Z-0863-2024Class Ismiths medical Medfusion Model 3500 Syringe pumpAbbott MedicalFRN
Z-1068-2024Class IIAccessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF...OriGen Biomedical, Inc.KJG
Z-0780-2024Class IIModel A710 Intellis Clinician Programmer Application, version 2.0.97Medtronic NeuromodulationLGW
Z-0787-2024Class IIiQ Waste Well Adapter, Part Number: 700-3393Siemens Healthcare Diagnostics Inc.LKM
Z-0786-2024Class IIREV 2 Flowcell Capsule Spare, Part Number: C04154Siemens Healthcare Diagnostics Inc.LKM
Z-0785-2024Class IIiQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c)...Siemens Healthcare Diagnostics Inc.LKM