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-0707-2007 | 1,25-Dihydroxyvitamin D RIA Kit -For the quantitative determination of 1,25... | Diasorin Inc. | MRG | ||
| Z-1255-06 | ExacTrac Robotics, sold alone as Robotic Tilt Module catalog 49720 and in a bundle as... | Brainlab, Inc. | JAI | ||
| Z-1309-06 | Boston Scientific Vesica Drill-In Bone Locator; sterile, single use only; REF/Catalog no... | Boston Scientific Corporation | JDR | ||
| Z-1308-06 | Boston Scientific Vesica Sling Kits with Drill-In Anchor System sterile, for single use... | Boston Scientific Corporation | JDR | ||
| Z-1439-06 | BioGenex brand Hepatitis B Virus Surface Antigen Antibody, Cat. No. AM364-5M and... | Biogenex Laboratories, Inc. | MVU | ||
| Z-1438-06 | BioGenex brand Hepatitis B Virus Core Antigen Antibody, Cat. No. AR082-5R and... | Biogenex Laboratories, Inc. | MVU | ||
| Z-1177-06 | Stryker brand Insufflation Tube Set and High Flow Insufflation Tube Set, Model Numbers... | Stryker Corp. | HET | ||
| Z-1203-06 | ImmunoCard toxins A & B kit, a rapid enzyme immunoassay for the detection of Clostridium... | Meridian Bioscience Inc | LLH | ||
| Z-0815-2007 | GE Healthcare-Americas Signa 3.0T EXCITE Whole Body Magnetic Resonance System | GE Healthcare | LNH | ||
| Z-0053-2007 | AMPLATZER PFO Occluder. Order No. 9-PFO-025. Device is not PMA approved in the US... | Abbott Medical | MLV | ||
| Z-0052-2007 | AMPLATZER PFO Occluder. Order No. 9-PFO-018. Device is not PMA approved in the US... | Abbott Medical | MLV | ||
| Z-1168-06 | CPS Implant Kit, Model 410190 | Abbott Medical | DQY | ||
| Z-1167-06 | CPS Aim, Models 410140, 410141, 410142, 410144, 410145, 410146, 410147, & 410148 | Abbott Medical | DQY | ||
| Z-1166-06 | CPS Direct SL, Models 410110, 410111, 410112, 410113, 410114, 410115, 410116, 410120... | Abbott Medical | DQY | ||
| Z-1165-06 | CPS Valve Bypass Tool (VBT), Model 410192 | Abbott Medical | DQY | ||
| Z-1164-06 | CPS Slitter, Model 410191 | Abbott Medical | DQY | ||
| Z-1087-2007 | GE Healthcare Proteus XR/a General Purpose Radiographic System, Models 2259973-4 and... | GE Healthcare | KPR | ||
| Z-1790-2012 | Class II | GE Proteus XR/a Radiographic System. GE Medical Systems-Americas Milwaukee, WI. Model... | GE Healthcare | KPR | |
| Z-1789-2012 | Class II | GE Healthcare Definium 8000 Digital Radiographic Systems : GE Healthcare, 3000 North... | GE Healthcare | MQB | |
| Z-1788-2012 | Class II | GE Healthcare Revolution XR/d; GE Healthcare, 3000 North Grandview , Waukesha, WI... | GE Healthcare | MQB | |
| Z-0001-2007 | GE 4 inch Anterior Cervical Post, GE Part Number 1006385 or 1006385-NAV, GE Healthcare... | GE Healthcare | JAA | ||
| Z-1218-06 | Boston Scientific IQ Guide Marker Wire. Catalog No. 38951-01J0, 185 cm, J-Tip, Single... | Boston Scientific Corporation | DQX | ||
| Z-1217-06 | Boston Scientific IQ Guide Marker Wire. Catalog No. 38951-010, 185 cm, Straight Tip... | Boston Scientific Corporation | DQX | ||
| Z-1216-06 | Boston Scientific IQ Guide Wire. Catalog No. 38950-02J0, 300 cm, J-Tip, Single Pack... | Boston Scientific Corporation | DQX | ||
| Z-1215-06 | Boston Scientific IQ Guide Wire. Catalog No. 38950-020, 300 cm, Straight Tip, Single... | Boston Scientific Corporation | DQX | ||
| Z-1214-06 | Boston Scientific IQ Guide Wire. Catalog No. 38950-01J0, 185 cm, J-Tip, Single Pack... | Boston Scientific Corporation | DQX | ||
| Z-1213-06 | Boston Scientific IQ Guide Wire. Catalog No. 38950-010, 185 cm, Straight Tip, Single... | Boston Scientific Corporation | DQX | ||
| Z-1334-2011 | S T-Bone Plate; M T-Compression Plate; Manufactured and Distributed by Stryker Lebinger... | Howmedica Osteonics Corp | HRS | ||
| Z-0321-2007 | RYM-5001 InVision-Plus Neutral Displacement I.V. Connector, packaged 100 units per box, 5... | RyMed Technologies, LLC | FPA | ||
| Z-0320-2007 | RYM-5000 InVision-Plus NEUTRAL I.V. Connector, packaged 200 units per box, 5 boxes per... | RyMed Technologies, LLC | FPA | ||
| Z-0319-2007 | RYM-5000 InVision-Plus Neutral Displacement I.V. Connector, packaged 200 units per box, 5... | RyMed Technologies, LLC | FPA | ||
| Z-1160-06 | ATEC Breast Biopsy and Excision System Needle Guide, 9 GA, sterile, in packages of 5, Ref... | Hologic, Inc. | KNW | ||
| Z-1221-06 | TriActiv System Balloon Inflation Syringe. The syringe packs/boxes contain 5 'spare'... | DSM Biomedical, Inc. | NFA | ||
| Z-1220-06 | TriActiv System Procedure Kit. Balloon Protected Flush Extraction System 340 cm (for... | DSM Biomedical, Inc. | NFA | ||
| Z-1219-06 | TriActiv System Procedure Kit. Balloon Protected Flush Extraction System 190 cm (for... | DSM Biomedical, Inc. | NFA | ||
| Z-1251-06 | Hamilton brand RAPHAEL Color Ventilator (Software Vesion. 2.2xC, 2.2xCU)Product is... | Hamilton Medical AG | CBK | ||
| Z-1250-06 | Hamilton brand RAPHAEL Silver Ventilator (Software Version 2.2xS) Product is distributed... | Hamilton Medical AG | CBK | ||
| Z-1249-06 | Hamilton brand RAPHAEL Ventilator (Software Versio 2.2x), Product is distributed by... | Hamilton Medical AG | CBK | ||
| Z-1171-06 | i-STAT EG7+ Cartridge, Blood Gas Panel. pH, PCO2 PO2, Na K iCa, Hct, HCO3 TCO2 BE, sO2... | Abbott Medical | JGS | ||
| Z-0379-2007 | Ventilator System Servo-i V3.1 Maquet Critical Care PC1771 | Maquet Cardiovascular Us Sales, LLC | CBK | ||
| Z-0372-2007 | Ventilator System SERVO-i V3.1 PC1777 Maquet Critical Care | Maquet Cardiovascular Us Sales, LLC | CBK | ||
| Z-1185-06 | Sterile Triumph LT Latex Powder-Free Surgeons Gloves; 50 pairs of gloves per box, 4 boxes... | Terang Nusa (Malaysia) Sdn. Bhd. | KGO | ||
| Z-1260-06 | Model #842-326 (pump tube for waste) & Model #842-327 (pump tube for solution), Waste... | Radiometer America, Inc | CHL | ||
| Z-1259-06 | Cytomics FC 500 Flow Cytometry System Part Numbers 626553 (TN; FC500 with UPS), 6605627... | Siemens Healthcare Diagnostics Inc. | LXG | ||
| Z-1514-06 | Smith & Nephew Hip Positioning System Ref: 72200624 with System Components: Perineal Post... | Smith & Nephew, Inc. | JEB | ||
| Z-1102-06 | Boston Scientific Wiseguide Guide Catheter 7F, .076 '', Femoral Approach, Manufactured... | Boston Scientific Corporation | DQY | ||
| Z-1153-06 | Auto Suture ChemoSite Implantable Venous Access System with 9FR Introducer Kit with... | Medtronic, Inc. | FOZ | ||
| Z-1152-06 | Auto Suture ChemoSite Catheter Introducer Kit with 9FR Peel-Away Sheath Catalog Number... | Medtronic, Inc. | FOZ | ||
| Z-1151-06 | Auto Suture ChemoSite Implantablei Venous Kit Access System with 9FR Introducer Kit... | Medtronic, Inc. | FOZ | ||
| Z-1150-06 | Auto Suture ChemoSite Catheter 9FR Introducer Kit with 9FR Peel-Away Sheath Catalog... | Medtronic, Inc. | FOZ |