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-0553-2010 | Bausch & Lomb Boston Conditioning Solution, Original Formula, Bausch & Lomb Incorporated... | Bausch & Lomb Incorporated | MRC | ||
| Z-0543-2010 | i-Cat Classic, 3D Dental Imaging System manufactured by Imaging Sciences International... | Dental Imaging Technologies Corporation | JAK | ||
| Z-0374-2010 | SureSigns Vital Signs Viewer (VSV):Spot Check Vital Signs Monitor with NBP (options to... | Philips North America LLC | MHX | ||
| Z-0373-2010 | SureSigns Vital Signs Monitors (VS3)-Vital Signs Viewer Central Viewing Station View up... | Philips North America LLC | MHX | ||
| Z-0372-2010 | SureSigns Patient Monitors (VM3, VM4. VM6. VM8): VM3 3/5 lead ECG/SPo2... | Philips North America LLC | MHX | ||
| Z-1020-2010 | RapidPoint 405 System Analyzers The RP405 is capable of testing all of the analytes... | Siemens Healthcare Diagnostics Inc. | CHL | ||
| Z-1019-2010 | RapidPoint 400 Analyzers for Blood Gas, Electrolytes and metabolites Software Versions... | Siemens Healthcare Diagnostics Inc. | CHL | ||
| Z-2026-2010 | ADVANTAGE Turbo 2-Button Shaver. Rx Only, Made In USA, NON STERILE. CONMED LINVATEC... | Linvatec Corporation | GEY | ||
| Z-1753-2010 | PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 10-112, 10-0113, and... | Diadexus, Inc. | NOE | ||
| Z-1752-2010 | PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 90116, 250 test kit... | Diadexus, Inc. | NOE | ||
| Z-1751-2010 | PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 90115, Beckman test kit... | Diadexus, Inc. | NOE | ||
| Z-1750-2010 | PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 90112, 50 test kit... | Diadexus, Inc. | NOE | ||
| Z-1749-2010 | PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 90110, 100 test kit... | Diadexus, Inc. | NOE | ||
| Z-1748-2010 | PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 90107, 100 test kit... | Diadexus, Inc. | NOE | ||
| Z-2384-2010 | Whatman Body Fluid Collection Paper- 903 California Newborn Screening Card Ref 110534 903... | Whatman, Inc. | JKA | ||
| Z-1942-2010 | Inova Diagnostics BINDAZYME Human C1q binding Circulating Immune Complex EIA Kit, Part#... | Inova Diagnostics, Inc. | DAK | ||
| Z-0870-2010 | ERIC (Electronic RapID Compendium) Version 1.0.77, Catalog Number R8323600, used in... | Remel Inc | JXB | ||
| Z-0856-2010 | UniCel DxI 800 and 600 Access Immunoassay Systems, UniCel DxC 880i, 860i, 660i, and 680i... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-2468-2011 | Newport e360 Ventilator, Model Number: e360 The e360 Ventilator System is intended to... | Newport Medical Instruments, Inc. | CBK | ||
| Z-0488-2010 | Elements Gutta Percha and Elements RealSeal Cartridges; Part Number: 972-1002, 972-1003... | Sybron Dental Specialties, Inc. | EKM | ||
| Z-0576-2010 | AccuSure, U-100 31 Gauge, 1cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle... | Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals | FMF | ||
| Z-0575-2010 | AccuSure, U-100 31 Gauge, 1/2cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle... | Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals | FMF | ||
| Z-0574-2010 | AccuSure, U-100 30 Gauge, 1cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle... | Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals | FMF | ||
| Z-0573-2010 | AccuSure, U-100 30 Gauge, 1/2cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle... | Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals | FMF | ||
| Z-0572-2010 | AccuSure, U-100 29 Gauge, 1cc Insulin Syringe, 1/2" Needles, Short Needle, packaged 10... | Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals | FMF | ||
| Z-0571-2010 | AccuSure, U-100 29 Gauge, 1/2cc Insulin Syringe, 1/2" Needles, Short Needle, packaged 10... | Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals | FMF | ||
| Z-0570-2010 | AccuSure, U-100 28 Gauge, 1cc Insulin Syringe, 1/2" Needles, Short Needle, packaged 10... | Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals | FMF | ||
| Z-0569-2010 | AccuSure, U-100 28 Gauge, 1/2cc Insulin Syringe, 1/2" Needles, Short Needle, packaged 10... | Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals | FMF | ||
| Z-0500-2010 | Medtronic Accessory Kit , Titan Anchor Accessory Kit, 3550-39, Single Use, RX Only... | Medtronic Neuromodulation | LGW | ||
| Z-0485-2010 | Axiom Artis Zee Multi-purpose, Model number 10094139 angiographic x-ray systems | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-0484-2010 | Axiom Artis dMP, Model number 7555365 angiographic x-ray systems | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-0483-2010 | Axiom Artis MP, Model number 5904466 angiographic x-ray systems | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-0176-2010 | Respironics V60 Ventilator | Respironics, Inc. | MNT | ||
| Z-0123-2010 | Stryker Instruments Navigation System II PC SPC-1 Assembly, Stryker Navigation... | Stryker Corp. | HAW | ||
| Z-0122-2010 | Stryker Instruments Navigation System II- CART, Stryker Navigation, Kalamazoo, MI... | Stryker Corp. | HAW | ||
| Z-1590-2010 | An Imaging device for medical procedures, to provide surgeons or operating room personnel... | Stryker Corp. | LMB | ||
| Z-0288-2011 | The product is a 19" Spacelabs Medical Flat Panel Display, Model 94260-19, manufactured... | GE Healthcare | DXJ | ||
| Z-1535-2010 | Dimension Vista CHEM 3 calibrator is an in vitro diagnostic product for the calibration... | Siemens Healthcare Diagnostics Inc. | JIX | ||
| Z-0458-2010 | Nonin Model 7600B cerebral oximeter pod. Used with the Nonin Model 7600 Regional... | Nonin Medical, Inc | MUD | ||
| Z-0335-2010 | 55CM ALTA LR GOLD STD KIT Model: ALC50SH55 ALTA GOLD 15.5 Fr polyurethane twin lumen... | Spire Biomedical, Inc. | MSD | ||
| Z-0334-2010 | 40CM ALTA LR GOLD STD KIT Model: ALC35SH40 ALTA GOLD 15.5 Fr polyurethane twin lumen... | Spire Biomedical, Inc. | MSD | ||
| Z-0333-2010 | 36CM ALTA LR GOLD STD KIT Model: ALC31SH36 ALTA GOLD 15.5 Fr polyurethane twin lumen... | Spire Biomedical, Inc. | MSD | ||
| Z-0332-2010 | 32CM ALTA LR GOLD STD KIT Model: ALC27SH32 ALTA GOLD 15.5 Fr polyurethane twin lumen... | Spire Biomedical, Inc. | MSD | ||
| Z-0331-2010 | 28CM ALTA LR GOLD STD KIT Model: ALC23SH28 ALTA GOLD 15.5 Fr polyurethane twin lumen... | Spire Biomedical, Inc. | MSD | ||
| Z-0330-2010 | 24CM ALTA LR GOLD STD KIT Model: ALC19SH24 ALTA GOLD 15.5 Fr polyurethane twin lumen... | Spire Biomedical, Inc. | MSD | ||
| Z-0329-2010 | 32CM ALTA EXCHANGE Model: AL27SH32 XP ALTA EXCHANGE KIT 15.5 Fr polyurethane twin... | Spire Biomedical, Inc. | MSD | ||
| Z-0328-2010 | 28CM ALTA EXCHANGE KIT Model: AL23SH28 XP ALTA EXCHANGE KIT 15.5 Fr polyurethane... | Spire Biomedical, Inc. | MSD | ||
| Z-0327-2010 | 24CM ALTA EXCHANGE KIT Model: AL19SH24-XP ALTA EXCHANGE KIT 15.5 Fr polyurethane... | Spire Biomedical, Inc. | MSD | ||
| Z-0326-2010 | 36CM ALTA LR STANDARD KIT Model: AL31NH36 ALTA CATHETER WITH NO SIDE HOLES 15.5 Fr... | Spire Biomedical, Inc. | MSD | ||
| Z-0325-2010 | 32CM ALTA LR STANDARD KIT Model: AL27NH32 ALTA CATHETER WITH NO SIDE HOLES 15.5 Fr... | Spire Biomedical, Inc. | MSD |