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
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-0790-03 | Vicks brand Warm Mist Humidifier, Model V610, ''Pure Warm Moisturizer for Soothing Relief... | KAZ Inc. | KFZ | ||
| Z-0933-03 | Gravity and Infusion Pump Intravenous (IV) Sets using the Y-site Ultrasite Valve... | B Braun Medical Inc | FPA | ||
| Z-0867-03 | Misys Laboratory System versions 5.2, 5.23, 5.3, 5.3.1 and 5.3.2. | CliniSys, Inc | JQP | ||
| Z-0786-03 | MAC-LAB (Classic) systems | GE Medical Systems Information Technologies, Inc. | KMI | ||
| Z-0785-03 | MAC-LAB 5000EX systems | GE Medical Systems Information Technologies, Inc. | KMI | ||
| Z-0784-03 | MAC-LAB 3000EX systems | GE Medical Systems Information Technologies, Inc. | KMI | ||
| Z-0783-03 | MAC-LAB 1000EX systems | GE Medical Systems Information Technologies, Inc. | KMI | ||
| Z-0802-03 | Non-Sterile Suture Needles, Reverse Cutting, 1/2 Circle, Stainless Steel; 12 suture... | HU-Friedy Mfg. Co. LLC | GAB-- | ||
| Z-0850-03 | Neonatal Catheter & Insertion Tray is simply a catheter kit that is comprised of the... | Vygon U.S.A. | DQO | ||
| Z-0849-03 | Nutriline with Peelable Sheath 2 Fr. is a 2 Fr. peripherally inserted catheter (PIC)... | Vygon U.S.A. | DQO | ||
| Z-0848-03 | ''NASCAR'', Electric Toothbrush, Model NC70. Powered toothbrush. | Emerson Radio Corp. | JEQ | ||
| Z-0847-03 | ''Hello Kitty'', Plaque Removing Toothbrush, Model HK70W. Powered toothbrush. | Emerson Radio Corp. | JEQ | ||
| Z-0839-03 | 3M Ioban 2 Antimicrobial Incise Drapes, Model 6651EZ | 3M Company | KKX | ||
| Z-0838-03 | 3M Ioban 2 Antimicrobial Incise Drapes, Model 6648EZ | 3M Company | KKX | ||
| Z-0801-03 | Anti-HBs Reagent Kit, list 7C18-25, 100 tests; Abbott Diagnostics, a Division of Abbott... | Abbott Medical | LOM-- | ||
| Z-0115-04 | CONFIRM c-KIT, Antibody (rabbit polyclonal), Catalog number 790-2939 | Ventana Medical Systems Inc | NKF | ||
| Z-0832-03 | BD First PICC 3F 65 cm Single Lumen Procedure Kit. | Becton Dickinson Infusion Therapy Systems Inc. | LJS | ||
| Z-0218-05 | TOSOH brand AIA-600 II Enzyme Immunoassay Analyzer; Software version 3.12, Catalog... | Tosoh Bioscience Inc | NIG | ||
| Z-0836-03 | Philips MX8000 Dual v. EXP CT Scanner, utilizing V2.0 software. | Philips North America LLC | JAK | ||
| Z-0835-03 | Philips MX8000 IDT CT Scanner, utilizing V2.1 software. | Philips North America LLC | JAK | ||
| Z-1151-04 | Synchron Liquid Comprehensive Chemistry Control Serum. Part numbers: 660710, 657365. | Siemens Healthcare Diagnostics Inc. | LEH | ||
| Z-1188-03 | CryoValve Heart Valve | Artivion, Inc. | MIE | ||
| Z-1026-03 | Vail Enclosed Bed System, model 2000 | Vail Products, Inc. | FNL | ||
| Z-1025-03 | Vail Enclosed Bed System, model 1000 | Vail Products, Inc. | FNL | ||
| Z-0975-03 | Acuson Cypress Echocardiography System. Imaging System | Siemens Medical Solutions USA, Inc. | IYN | ||
| Z-0920-03 | Misys Commercial Laboratory version 2.x thru 3.4.1 | CliniSys, Inc | JQP | ||
| Z-0794-03 | Gemstar Therapy Pain Management I. V. Infusion Pump, List #: 13150-04; 2.9 Software... | Abbott Medical | FRN | ||
| Z-0793-03 | Gemstar 6 Therapy I.V. Infusion Pump, List #: 13100-04; 2.9 Software Version | Abbott Medical | FRN | ||
| Z-0792-03 | Gemstar 7 Therapy I.V. Infusion Pump, List#: 13000-04; 2.9 Software Version | Abbott Medical | FRN | ||
| Z-0807-03 | Misys Laboratory System version 5.3 | CliniSys, Inc | |||
| Z-0775-03 | Guidant Multi-Link Vision Coronary Stent System Catalog Numbers: 30 different catalog... | Abbott Vascular | |||
| Z-0780-03 | Vision Hollow Fiber Oxygenator | Gish Biomedical, Inc. | |||
| Z-0865-03 | Acuson Diagnostic Ultrasound System Transducer; Model Number(s): L582 Linear Array... | Siemens Medical Solutions USA, Inc. | MAA | ||
| Z-0864-03 | Acuson Diagnostic Ultrasound System Transducer; Model Number(s): L582 Linear Array... | Siemens Medical Solutions USA, Inc. | MAA | ||
| Z-0782-03 | Architect Progesterone Reagent Kit; list 6C26-27 (100 tests) and 6C26-22 (400 tests)... | Abbott Medical | JLS | ||
| Z-0202-06 | PROFlex Transporter, Model number 35P. The catalog number for the model 35P is PT3550. | Ferno-Washington Inc | FPO | ||
| Z-0201-06 | PROFlex Transporter, Model numbers 35PST. The catalog number for the model 35PST is... | Ferno-Washington Inc | FPO | ||
| Z-0805-03 | COULTER PrepPlus and PrepPlus 2, Pipetting and Diluting station for Clinical Use | Siemens Healthcare Diagnostics Inc. | JQW | ||
| Z-0803-03 | Aeroset Direct HDL Reagent, LN 7D67-01 | Abbott Medical | |||
| Z-0950-03 | Bindazyme, Human AntiCardiolipin IgM Enzyme Immunoassay Kits, MK029 | The Binding Site | MID | ||
| Z-0804-03 | Misys Laboratory System versions 5.23 and 5.3 | CliniSys, Inc | |||
| Z-0919-03 | Vitros TP Slides, for in vitro diagnostic use to quantitatively measure total protein... | Ortho-Clinical Diagnostics, Inc. | CEK | ||
| Z-0791-03 | Misys Laboratory System versions 5.23 and 5.3 | CliniSys, Inc | JQP | ||
| Z-0908-03 | Model 8666 Washer/Disinfector with holding tank heater option. Firm on label is Getinge... | Getinge/Castle, Inc. | MEC | ||
| Z-0732-03 | Bard Dispoz-A-Bag, Disposable Urinary Leg Bags, with Flip-Flo Drainage Valve, 19 oz or 32... | C.R. Bard Inc | FAQ | ||
| Z-0774-03 | Valve Accessory Pack | Windstone Medical Packaging, Inc. | |||
| Z-0773-03 | Isolation Gown Pack | Windstone Medical Packaging, Inc. | |||
| Z-0772-03 | Subclavian Procedure Tray | Windstone Medical Packaging, Inc. | |||
| Z-0771-03 | Penrose Ace Bandage | Windstone Medical Packaging, Inc. | |||
| Z-0770-03 | Pick Up Pack | Windstone Medical Packaging, Inc. |