510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK 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

59,544 records, page 613 of 1191
FDA device recalls, page 613 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0572-2016Class IICNSystems TASK FORCE MONITOR 3040i, plethysmograph, impedance. Noninvasively measure and...Partners in Medicine LLCDSB
Z-2584-2017Class IIPalcam Supplement Acumedia PN 7987 Product Usage: PALCAM Supplement is used with PALCAM...Neogen Culture MediaJSI
Z-1043-2016Class IIColumbus Revision Knee System, EnduRo Knee System Product Usage: The Columbus Revision...Aesculap IncJWH
Z-0627-2016Class IIMedrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego...Medrad, Inc.FRN
Z-0607-2016Class IIBaxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.C. Access...Baxter Healthcare CorporationNEP
Z-0606-2016Class IIBaxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, Male Luer...Baxter Healthcare CorporationFPA
Z-0605-2016Class IIBaxter Y-Type Spike Adapter, 7" (18 cm), 1C8433, Product Usage: C8433: For the...Baxter Healthcare CorporationFPA
Z-0421-2016Class IIGlideScope AVL Video Laryngoscope (AVL), Part Number AVL 3- 0574-0115; AVL 4-0574-0116...Verathon Inc.CCW
Z-0420-2016Class IIGlideScope Video Laryngoscope (GVL), Part Number GVL 3 - 0574-0007; GVL 4 - 0574-0001...Verathon Inc.CCW
Z-1091-2016Class IIBladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and...Verathon Inc.IYO
Z-0808-2016Class IIBond Polymer Refine Red Detection DS9390 kits. The common name of the device is detection...Leica Microsystems, Inc.NJT
Z-2524-2016Class IICertain Gingihue 15 degree Angled Post Dental implantsZimVie US Corp LLCNHA
Z-2523-2016Class IICertain Gingihue Post Dental implantsZimVie US Corp LLCNHA
Z-2522-2016Class IICertain Gingihue 15 degree Pre- Angled Post Dental implantsZimVie US Corp LLCNHA
Z-2521-2016Class IICertain Gingihue TM 15 degree Angled Post Dental implantsZimVie US Corp LLCDZE
Z-2520-2016Class IICertain Flat Implant Cover Screw Dental implantsZimVie US Corp LLCDZE
Z-2519-2016Class IICertain EP Twist Lock TM Coping Dental implantsZimVie US Corp LLCNHA
Z-2518-2016Class IICertain EP Pick-Up Coping Dental implantsZimVie US Corp LLCNHA
Z-2517-2016Class IICertain EP Healing Abutment Dental implantsZimVie US Corp LLCNHA
Z-2516-2016Class IICertain Cover Screw Dental implantsZimVie US Corp LLCDZE
Z-2515-2016Class IICertain Conical Abutment Dental implantsZimVie US Corp LLCNHA
Z-2514-2016Class IICertain Conical 25 degree Angled Abutment Dental implantsZimVie US Corp LLCNHA
Z-2513-2016Class IICertain Conical 17 degree Angled Abutment Dental implantsZimVie US Corp LLCNHA
Z-2512-2016Class IICertain Bellatek Encode Healing Abutment Dental implantsZimVie US Corp LLCNHA
Z-2511-2016Class IICertain EP Twist Lock TM Coping Dental implantsZimVie US Corp LLCNHA
Z-2510-2016Class IIBellatek Encode Healing Abutment Dental implantsZimVie US Corp LLCNHA
Z-2509-2016Class IICertain EP Healing Abutment 4.1mm(D) x 5mm(P) x 2mm(H) Item: ITHA52 Dental implantsZimVie US Corp LLCNHA
Z-2508-2016Class IIConical Abutment Pick-up Coping Dental implantsZimVie US Corp LLCNHA
Z-2507-2016Class IIConical Abutment Gold Standard ZR TM Dental implantsZimVie US Corp LLCNHA
Z-2506-2016Class IIConical Abutment Dental implantsZimVie US Corp LLCNHA
Z-2505-2016Class IIConical 25 degree Angled Abutment Dental implantsZimVie US Corp LLCNHA
Z-2504-2016Class IIConical 17 degree Angled Abutment Dental implantsZimVie US Corp LLCNHA
Z-2503-2016Class IICertain Twist Lock TM Coping Dental implantsZimVie US Corp LLCNHA
Z-2502-2016Class IICertain Twist Lock TM Straight Transfer Coping Dental implantsZimVie US Corp LLCNHA
Z-2501-2016Class IICertain Twist Lock TM Coping Dental implantsZimVie US Corp LLCNHA
Z-2500-2016Class IICertain Titanium Large Hexed Screw Dental implantsZimVie US Corp LLCDZE
Z-2499-2016Class IICertain Temporary Non-Hexed Cylinder Dental implantsZimVie US Corp LLCNHA
Z-2498-2016Class IICertain Temporary Hexed Cylinder Dental implantsZimVie US Corp LLCNHA
Z-2497-2016Class IICertain Straight Pick Up Coping Dental implantsZimVie US Corp LLCNHA
Z-2496-2016Class IICertain Straight Healing Abutment Dental implantsZimVie US Corp LLCNHA
Z-2495-2016Class IICertain Standard Abutment Dental implantsZimVie US Corp LLCNHA
Z-2494-2016Class IICertain Provide Abutment Dental implantsZimVie US Corp LLCNHA
Z-2493-2016Class IICertain Preformance Temporary Cylinder Dental implantsZimVie US Corp LLCNHA
Z-2492-2016Class IICertain Preformance Post Dental implantsZimVie US Corp LLCNHA
Z-2491-2016Class IICertain Preformance 15 degrees Pre-Angled Post Dental implantsZimVie US Corp LLCNHA
Z-2490-2016Class IICertain Pick-up Coping Dental implantsZimVie US Corp LLCNHA
Z-2489-2016Class IICertain Non-Hexed Implant Pick-up Coping Dental implantsZimVie US Corp LLCNHA
Z-2488-2016Class IICertain Micromini Flat Implant Cover Screw Dental implantsZimVie US Corp LLCDZE
Z-2487-2016Class IICertain Locator Abutment Dental implantsZimVie US Corp LLCDZE
Z-2486-2016Class IICertain IOL Abutment Dental implantsZimVie US Corp LLCNHA