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 1129 of 1190
FDA device recalls, page 1129 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0367-05System 1000 family of Hemodialysis Instruments, including the System 1000, Arena, 1550...Baxter Healthcare Renal DivFII
Z-0701-05Product is CSN00200 4MHz blood flowmeter probe used with the Quantix/OR system.Neoprobe Corp.DPW
Z-0700-05Product is CSN00210 8MHz blood flowmeter probe used with the Quantix/OR system.Neoprobe Corp.DPW
Z-0692-5FluroTrak 9800 Plus Navigation and Visualization SystemGE HealthcareJAA
Z-0691-05InstaTrak 3500 Plus Navigation and Visualization SystemGE HealthcareLLZ
Z-0690-05InstaTrak 3500 Navigation and Visualization SystemGE HealthcareLLZ
Z-0689-05InstaTrak 3000 Navigation and Visualization SystemGE HealthcareLLZ
Z-0688-05ENTrak Plus Navigation and Visualization SystemGE HealthcareLLZ
Z-0687-05ENTrak Navigation and Visualization SystemGE HealthcareLLZ
Z-0856-05Discovery Channel brand 8-Way Massager with Heat; therapeutic massager; Wahl Clipper...Wahl Clipper CorpISA
Z-0440-05Mammotome EX HolsterEthicon Endo-Surgery IncKNW
Z-0721-05Shiley FlexTra brand Flexible Dual-Cannula Tracheostomy Tube, Models: 358060, Size 6...Medtronic, Inc.JDH
Z-0348-05Sunsoft Multiples Toric, methafilcon A, clear contact lens.Ocular SciencesLPL
Z-0392-05Logix-CM Compounder Software, catalog 2M8400; Baxter Healthcare Corporation, Medication...Baxter Healthcare CorporationLHI
Z-0434-05VISTA BRITE TIP RDC(1) Guiding Catheter. Product Code 67021055, lot X0704002...Cordis US Corp.DQY
Z-0430-05Bio-Med Dental Breathing Circuit Product NUmber: DENTLBio-Med Devices, Inc.CBK
Z-0429-05Bio-Med Patient Breathing Circuit Product NUmber: 3030-5 Labeled in part: ONE SET...Bio-Med Devices, Inc.CBK
Z-0428-05Pneumotach, Disposable (B) Catalog Number: 4408 Labeled in part: SINGLE USE...Bio-Med Devices, Inc.CBK
Z-0427-05Bio Med Devices Patient Breathing Circuit Catalog Number: 8002A-9 Labeled in part: ONE...Bio-Med Devices, Inc.CBK
Z-0426-05Bio Med Devices Patient Breathing Circuit Catalog Number: 8002A-7 Labeled in part...Bio-Med Devices, Inc.CBK
Z-0425-05Bio Med Devices Patient Breathing Circuit Catalog Number: 8002A Labeled in part: ONE...Bio-Med Devices, Inc.CBK
Z-0424-05Bio Med Devices Patient Breathing Circuit Catalog Number: 80015 Labeled in part: DO NOT...Bio-Med Devices, Inc.CBK
Z-0423-05Bio Med Devices Patient Breathing Circuit Catalog Number: 80011 Labeled in part...Bio-Med Devices, Inc.CBK
Z-0900-05Gold Hub Monty Infiltration Cannula, Catalog Nos. IC14HM20; IC16HM15; IC18HM15; IC14HM20...HK Surgical IncFIE
Z-0899-05Gold Hub Finesse Cannula, Catalog Nos. HK10F23; HK12F10; HK12F15; HK12F23; HK14F10...HK Surgical IncFIE
Z-0898-05Gold Hub Capistrano Cannula, Catalog Nos. HK10C15; HK10C23;HK12C15;HK12C23: HK14C15...HK Surgical IncFIE
Z-0550-05Brand Name of Device: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory...E-Z-EM, IncJAK
Z-0549-05Brand Name: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual...E-Z-EM, IncJAK
Z-0548-05Brand Name: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual...E-Z-EM, IncJAK
Z-0492-05Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505...Abbott MedicalFPA
Z-0491-05Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505...Abbott MedicalFPA
Z-0490-05Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505...Abbott MedicalFPA
Z-0489-05Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505...Abbott MedicalFPA
Z-0488-05Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505...Abbott MedicalFPA
Z-0487-05Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505...Abbott MedicalFPA
Z-0486-05Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505...Abbott MedicalFPA
Z-0485-05Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505...Abbott MedicalFPA
Z-0484-05Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505...Abbott MedicalFPA
Z-0483-05Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505...Abbott MedicalFPA
Z-0482-05Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505...Abbott MedicalFPA
Z-0481-05Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505...Abbott MedicalFPA
Z-0480-05Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505...Abbott MedicalFPA
Z-0479-05Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505...Abbott MedicalFPA
Z-0478-05Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505...Abbott MedicalFPA
Z-0477-05Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505...Abbott MedicalFPA
Z-0476-05Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505...Abbott MedicalFPA
Z-0475-05Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505...Abbott MedicalFPA
Z-0474-05Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505...Abbott MedicalFPA
Z-0473-05Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505...Abbott MedicalFPA
Z-0472-05Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505...Abbott MedicalFPA