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 161 of 1190
FDA device recalls, page 161 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2091-2025Class IIITrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that...Stratasys Inc.EBI
Z-2090-2025Class IIITrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that...Stratasys Inc.EBI
Z-1203-2024Class IIRef No: INSHITHRZN / Integra Cranial Access Kit. For access to the subarachnoid space or...Integra LifeSciences CorporationHBG
Z-1202-2024Class IIRef No: INSHITHND / Integra Cranial access kit (without Prep solutions) Bit and Guard...Integra LifeSciences CorporationHBG
Z-1201-2024Class IIRef No: INSHITH / Integra Cranial Access Kit. For access to the subarachnoid space or the...Integra LifeSciences CorporationHBG
Z-1200-2024Class IIINS7280 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral...Integra LifeSciences CorporationHBG
Z-1199-2024Class IIRef No: INS7270 / Integra Cranial Access Kit. For access to the subarachnoid space or the...Integra LifeSciences CorporationHBG
Z-1198-2024Class IIRef No: INS7260 / Integra Cranial Access Kit. For access to the subarachnoid space or the...Integra LifeSciences CorporationHBG
Z-1197-2024Class IIRef No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid space or the...Integra LifeSciences CorporationHBG
Z-1179-2024Class IIGORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number...W. L. Gore & Associates, Inc.FGE
Z-1196-2024Class IIRef No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For...Integra LifeSciences CorporationHBG
Z-1195-2024Class IIRef No: HITHSP06 / Integra Cranial Access Kit. For access to the subarachnoid space or...Integra LifeSciences CorporationHBG
Z-1194-2024Class IIRef No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid space or...Integra LifeSciences CorporationHBG
Z-1193-2024Class IIRef No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access to the...Integra LifeSciences CorporationHBG
Z-1276-2024Class IIConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4...ConvaTec LimitedFON
Z-1368-2024Class IIInstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during...OLYMPUS Corporation of the AmericasEOB
Z-1168-2024Class IIW&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number...W & H DentalWerk Buermoos GmbHKMW
Z-1187-2024Class IMIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: a) MIC*...Halyard HealthKNT
Z-1186-2024Class IMIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal...Halyard HealthKNT
Z-1077-2024Class IIBEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with...Maquet Cardiovascular Us Sales, LLCDTZ
Z-1076-2024Class IIModel No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077...Maquet Cardiovascular Us Sales, LLCDTZ
Z-1009-2024Class IIWater Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with...OLYMPUS Corporation of the AmericasFEB
Z-1394-2024Class IIIV Start Kit, containing 1 Saline Syringe 5ml, REF 74654, 100 kits/case, Sterile.Medical Action Industries, Inc. 306LRS
Z-1333-2024Class IIDirectional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC
Z-1332-2024Class IIDirectional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC
Z-1331-2024Class IIDirectional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC
Z-1170-2024Class II3M Specialty Blade Assembly, REF 9660,70-2011-8491-1, 7100213026, used with used with 3M...3M CompanyLWK
Z-1169-2024Class II3M Specialty Blade Assembly, REF 9660,70-2011-8462-2, 7100213114, used with used with 3M...3M CompanyLWK
Z-1253-2024Class IIThe Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end...Medtronic, Inc.MFE
Z-1252-2024Class IIThe Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end...Medtronic, Inc.MFE
Z-1214-2024Class IIColonoscope, Model Number PCF-Q180AL.OLYMPUS Corporation of the AmericasNWB
Z-1213-2024Class IIColonoscope, Model Number PCF-HQ190L.OLYMPUS Corporation of the AmericasNWB
Z-1212-2024Class IIColonoscope, Model Number PCF-H190TL.OLYMPUS Corporation of the AmericasNWB
Z-1211-2024Class IIColonoscope, Model Number PCF-H190L.OLYMPUS Corporation of the AmericasFDF
Z-1210-2024Class IIColonoscope, Model Number PCF-H190DL.OLYMPUS Corporation of the AmericasNWB
Z-1209-2024Class IIColonoscope, Model Number PCF-H180AL.OLYMPUS Corporation of the AmericasNWB
Z-1208-2024Class IIColonoscope, Model Number CF-Q180AL.OLYMPUS Corporation of the AmericasNWB
Z-1207-2024Class IIColonoscope, Model Number CF-HQ190L.OLYMPUS Corporation of the AmericasFDF
Z-1206-2024Class IIColonoscope, Model Number CF-HQ190I.OLYMPUS Corporation of the AmericasFDF
Z-1205-2024Class IIColonoscope, Model Number CF-H180AL.OLYMPUS Corporation of the AmericasNWB
Z-1008-2024Class IIBrasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur...Brasseler USA I, L.P.EJL
Z-1273-2024Class IISynapse PACS - Version 7.3.000FUJIFILM Healthcare Americas CorporationLLZ
Z-1272-2024Class IISynapse PACS - Version 7.2.200FUJIFILM Healthcare Americas CorporationLLZ
Z-1271-2024Class IISynapse PACS - Version 7.2.100FUJIFILM Healthcare Americas CorporationLLZ
Z-1270-2024Class IISynapse PACS - Version 7.2.000FUJIFILM Healthcare Americas CorporationLLZ
Z-1269-2024Class IISynapse PACS - Version 7.1.000USFUJIFILM Healthcare Americas CorporationLLZ
Z-1268-2024Class IISynapse PACS - Version 7.1.000FUJIFILM Healthcare Americas CorporationLLZ
Z-1065-2024Class IAirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF...Jaeger Medical GmbHBTM
Z-1064-2024Class IAirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask...Jaeger Medical GmbHBTM
Z-1063-2024Class IAirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2...Jaeger Medical GmbHBTM