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-1960-2009 | Stryker Reflex Hybrid Variable Self-Tapping Screw. Non Sterile. Manufactured by Stryker... | Howmedica Osteonics Corp | KWQ | ||
| Z-1959-2009 | Stryker Reflex Hybrid variable self-drilling screw. Non Sterile. Manufactured by... | Howmedica Osteonics Corp | KWQ | ||
| Z-1958-2009 | Stryker Reflex Hybrid Level Anterior Cervical Plate; Non Sterile; Manufactured by... | Howmedica Osteonics Corp | KWQ | ||
| Z-1419-06 | LumiWave 1X4 Infrared Therapy Device, Catalog # LW1X4, BioCare Systems, Inc. | Biocare Systems, Inc. | ILY | ||
| Z-1400-06 | Pronto M51 Wheelchair, component- seat | Invacare GmbH | ITI | ||
| Z-0746-2007 | Vaxcel Implantable Vascular Access System - Plastic Standard Port With 9F Polyurethane... | Boston Scientific Corporation | LJT | ||
| Z-0745-2007 | Vaxcel Implantable Vascular Access System -Titanium Standard Port With 9F Polyurethane... | Boston Scientific Corporation | LJT | ||
| Z-1459-06 | Auto HDL Cholesterol reagent in bottles of 320 ml and 1000 ml, sold by Pointe Scientific... | Horiba Instruments Incorporated | CCH | ||
| Z-1458-06 | Auto HDL reagent, sold by Pointe Scientific; Catalog no. 3-H7545-L . | Horiba Instruments Incorporated | CCH | ||
| Z-1457-06 | AutoHDL Cholesterol R2 Reagent Set, a homogeneous method for the direct determination of... | Horiba Instruments Incorporated | CCH | ||
| Z-1456-06 | AutoHDL Cholesterol R1 Reagent Set, a homogeneous method for the direct determination of... | Horiba Instruments Incorporated | CCH | ||
| Z-1455-06 | AutoHDL Cholesterol Reagent Set for the quantitative determination of high density... | Horiba Instruments Incorporated | CCH | ||
| Z-1454-06 | Liquid AutoHDL Cholesterol Reagent Set, Manufactured for Pointe Scientific, Inc... | Horiba Instruments Incorporated | CCH | ||
| Z-1397-06 | Alk Phos R2 (also labeled as Alkaline Phosphatase R2) Reagent in 30 ml, 90 ml, 125 ml and... | Horiba Instruments Incorporated | CJE | ||
| Z-1396-06 | Alk Phos R1 (also labeled as Alkaline Phosphatase R1) Reagent in 50 ml, 120 ml, 2 L and... | Horiba Instruments Incorporated | CJE | ||
| Z-1395-06 | Liquid Alk Phos R2 Reagent, sold by Pointe Scientific; Catalog no. 3-A7516-R2. In vitro... | Horiba Instruments Incorporated | CJE | ||
| Z-1394-06 | Liquid Alk Phos R1 Reagent, sold by Pointe Scientific; Catalog no. 3-A7516-R1. In vitro... | Horiba Instruments Incorporated | CJE | ||
| Z-1393-06 | Liquid Alk Phos Reagent, sold by Pointe Scientific; Catalog no. 3-A7516-L. In vitro... | Horiba Instruments Incorporated | CJE | ||
| Z-1392-06 | Alkaline Phosphatase Substrate Mfg. for Alfa Wassermann Diagnostic Technologies LLC... | Horiba Instruments Incorporated | CJE | ||
| Z-1391-06 | Alkaline Phosphatase Buffer Mfg. for Alfa Wassermann Diagnostic Technologies LLC... | Horiba Instruments Incorporated | CJE | ||
| Z-1390-06 | Liquid Alkaline Phosphatase (R2) Reagent Set for the quantitative determination of... | Horiba Instruments Incorporated | CJE | ||
| Z-1389-06 | Liquid Alkaline Phosphatase (R1) Reagent Set for the quantitative determination of... | Horiba Instruments Incorporated | CJE | ||
| Z-1549-06 | Alcohol Standard sold by Pointe Scientific; Catalog # 7-A7504-STD. | Horiba Instruments Incorporated | JIX | ||
| Z-1548-06 | Alcohol Control, Level 2 sold by Pointe Scientific; Catalog # 7-A7504-CTL-L2. | Horiba Instruments Incorporated | JIX | ||
| Z-1547-06 | Alcohol Control, Level 1 sold by Pointe Scientific; Catalog # 7-A7504-CTL-L1. | Horiba Instruments Incorporated | JIX | ||
| Z-1546-06 | Alcohol Control sold by Pointe Scientific; Catalog # 7-A7504-CTL. | Horiba Instruments Incorporated | JIX | ||
| Z-1545-06 | Alcohol Standard, 100 mg/dl, Pointe Scientific Inc., Canton, MI; Catalog # A7504-STD. | Horiba Instruments Incorporated | JIX | ||
| Z-1544-06 | Alcohol Reagent Set for the quantitative determination of ethyl alcohol in serum... | Horiba Instruments Incorporated | JIX | ||
| Z-1244-06 | CA 15-3 Controls, list 9C08-10; an In Vitro diagnostic for use with the AxSYM or IMx CA... | Abbott Medical | MOI | ||
| Z-1543-06 | Ammonia/alcohol Control Set for the quantitative determination of ammonia/alcohol in... | Horiba Instruments Incorporated | JIX | ||
| Z-1388-06 | Liquid Alkaline Phosphatase Reagent Set for the quantitative determination of alkaline... | Horiba Instruments Incorporated | CJE | ||
| Z-0099-2011 | SoftWeb version 4.0.4.10.1. SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL... | SCC Soft Computer | LNX | ||
| Z-0157-2007 | The affected device is labeled Angio-Seal Vascular Closure Device 6F VIP Platform, model... | Abbott Medical | MGB | ||
| Z-1333-06 | Glucose HEX R2 reagent sold by Pointe Scientific; in vitro diagnostic, Catalog nos... | Horiba Instruments Incorporated | CFR | ||
| Z-1332-06 | Glucose HEX R1 reagent sold by Pointe Scientific; in vitro diagnostic, Catalog nos... | Horiba Instruments Incorporated | CFR | ||
| Z-1331-06 | Glucose HEX reagent sold by Pointe Scientific; in vitro diagnostic, Catalog no. 3-HG920-L. | Horiba Instruments Incorporated | CFR | ||
| Z-1330-06 | Glucose Hex reagent, sold by Pointe Scientific; in vitro diagnostic, Catalog no... | Horiba Instruments Incorporated | CFR | ||
| Z-1329-06 | Pointe Scientific Liquid Glucose (HEXO) Reagent Set, for the quantitative determination... | Horiba Instruments Incorporated | CFR | ||
| Z-1328-06 | Pointe Scientific Liquid Glucose (HEX) Reagent Set, for the quantitative determination of... | Horiba Instruments Incorporated | CFR | ||
| Z-1327-06 | Pointe Scientific Liquid Glucose HEX (R2) Reagent Set, for the quantitative determination... | Horiba Instruments Incorporated | CFR | ||
| Z-1187-06 | ArthroCare brand OPUS Smartstitch Magnum Wire Suture Cartridge, Catalog Number... | ArthroCare Corporation | KOG | ||
| Z-1186-06 | ArthroCare brand OPUS Smartstitch Suture Cartridge, Catalog Number: OM-8071; Product is... | ArthroCare Corporation | KOG | ||
| Z-1326-06 | Pointe Scientific Liquid Glucose HEX (R1) Reagent Set, for the quantitative determination... | Horiba Instruments Incorporated | CFR | ||
| Z-1176-06 | Roche Calcium Reagent Kit for use on the Cobas MIRA Chemistry System; in vitro... | Roche Diagnostics GmbH | CIC | ||
| Z-1088-2007 | GE Innova 2100-IQ Digital Fluoroscopic Imaging System, Versatile cardiac and vascular... | GE Healthcare | MQB | ||
| Z-0608-2013 | Class III | Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is... | Radiometer America, Inc | JJE | |
| Z-1206-06 | Varian brand Clinac C-series Pendant Radiation delivery system. All model numbers... | Varian Medical Systems, Inc. | IYE | ||
| Z-1258-06 | St. Francis Medical Technologies brand X STOP Interspinous Process Decompression (IPD)... | Medtronic, Inc. | NQO | ||
| Z-1204-06 | ARCHITECT Ferritin Reagent; in vitro diagnostic; list numbers 6C11-20 (4 x 100 tests)... | Abbott Medical | DBF | ||
| Z-0022-2007 | Medtronic SynchroMed EL Programmable Pumps, Models 8627-10, 8627-18, 8627L-10, 8627L-18... | Medtronic Neuromodulation | LKK |