510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK 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

59,476 records, page 213 of 1190
FDA device recalls, page 213 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1413-2023Class IIINFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 34mm...Medtronic Sofamor Danek USA IncKWP
Z-1412-2023Class IIINFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 26mm...Medtronic Sofamor Danek USA IncKWP
Z-1411-2023Class IIINFINITY Occipitocervical Upper Thoracic System, PARTIALLY THREADED MULTI AXIAL SCREW...Medtronic Sofamor Danek USA IncKWP
Z-1410-2023Class IIINFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 32mm...Medtronic Sofamor Danek USA IncKWP
Z-1409-2023Class IIINFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm...Medtronic Sofamor Danek USA IncKWP
Z-1891-2025Class IIFoundationOne Companion Diagnostic (F1CDx)Foundation Medicine, Inc.PQP
Z-2098-2023Class IIKLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in...Pro-Dex IncGEY
Z-1352-2023Class IIFlex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/AMerit Medical Systems, Inc.FJS
Z-1267-2023Class IIAttune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507Depuy Orthopaedics Inc.OIY
Z-1266-2023Class IIAttune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number...Depuy Orthopaedics Inc.KRO
Z-1265-2023Class IIAttune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number...Depuy Orthopaedics Inc.KRO
Z-1264-2023Class IIAttune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number...Depuy Orthopaedics Inc.KRO
Z-1263-2023Class IIAttune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number...Depuy Orthopaedics Inc.KRO
Z-0976-2025Class IIBD Pyxis Med 4000 Auxiliary (AUX), REF 314CareFusion 303, IncBRY
Z-0975-2025Class IIBD Pyxis Med ES Auxiliary (AUX), REF 343CareFusion 303, IncBRY
Z-0974-2025Class IIBD Pyxis MedStation 4000 AUX, REF 306CareFusion 303, IncBRY
Z-0973-2025Class IIBD Pyxis MedStation 4000 Main, REF 303CareFusion 303, IncBRY
Z-0972-2025Class IIBD Pyxis MedStation ES AUX, REF 324CareFusion 303, IncBRY
Z-0971-2025Class IIBD Pyxis MedStation ES (Med ES Main), REF 323CareFusion 303, IncBRY
Z-1050-2025Class IIBD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF...CareFusion 303, IncBRY
Z-1380-2023Class IIEdward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution...Edwards Lifesciences LLCDYG
Z-1379-2023Class IIEdward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution...Edwards Lifesciences LLCDYG
Z-1391-2023Class IIKLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used...Pro-Dex IncGET
Z-1312-2023Class IIDDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of...Defibtech LLCMKJ
Z-1282-2023Class IIClariti 1-day toric soft contact lenses, Power -1.00 -1.25/90CooperVision, Inc.LPL
Z-1255-2023Class IIAmicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis...Fenwal IncLKN
Z-1254-2023Class IIAmicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural...Fenwal IncLKN
Z-1259-2023Class IIBrainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System...Brainlab, Inc.IYE
Z-1207-2023Class IIBD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med ES Main)...CareFusion 303, IncBRY
Z-1348-2023Class IIGlobal Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo...CooperSurgical, Inc.MQL
Z-1275-2023Class IFreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle...Abbott MedicalQLG
Z-1274-2023Class IFreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the FreeStyle...Abbott MedicalPZE
Z-1273-2023Class IFreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle...Abbott MedicalPZE
Z-1188-2023Class IIBEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS...Maquet Cardiovascular Us Sales, LLCDTZ
Z-1318-2023Class IICOVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley...Medtronic, Inc.BTR
Z-1322-2023Class IPhilips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11...Respironics, Inc.BZD
Z-1235-2023Class IISensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version...Sensus HealthcareJAD
Z-1196-2023Class IIMultiLab Series II REVO non-invasive vascular diagnostic device, Model Number...Unetixs Vascular, Inc.JAF
Z-1195-2023Class IIMultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number...Unetixs Vascular, Inc.JAF
Z-1194-2023Class IIMultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number...Unetixs Vascular, Inc.JAF
Z-1193-2023Class IIMultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model...Unetixs Vascular, Inc.JAF
Z-1293-2023Class IIda Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200Intuitive Surgical, Inc.NAY
Z-0734-2024Class IIFreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the...Abbott MedicalQLG
Z-1283-2023Class IIDeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000BDeRoyal Industries, Inc.KDQ
Z-1334-2023Class IIMedtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106; b) DBM...Medtronic Sofamor Danek USA IncMBP
Z-1333-2023Class IIMedtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120; b) DBM S41150 GRAFTON...Medtronic Sofamor Danek USA IncMBP
Z-1332-2023Class IIMedtronic Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF...Medtronic Sofamor Danek USA IncMBP
Z-1331-2023Class IIMedtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON...Medtronic Sofamor Danek USA IncMBP
Z-1330-2023Class IIMedtronic Grafton DBF: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101; b) PUTTY...Medtronic Sofamor Danek USA IncMBP
Z-1329-2023Class IIMedtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; b) DBM...Medtronic Sofamor Danek USA IncMBP