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-0203-05 | AccessALS (Advanced Life Support) Model Number: 9100-0100-2 | Access Cardiosystems, Inc. | MKJ | ||
| Z-0202-05 | AccessAED Package (with audio record) Model Number: 9100-0150-1 | Access Cardiosystems, Inc. | MKJ | ||
| Z-0201-05 | AccessAED (with audio record) Model Number: 9100-0100-1 | Access Cardiosystems, Inc. | MKJ | ||
| Z-0200-05 | AccessAED Package (without audio record) Model Number: 9100-0150-0 | Access Cardiosystems, Inc. | MKJ | ||
| Z-0257-05 | Stellant Dual Syringe Kits. CT Injector and Accessories. Catalog Number SDS-CTP-QFT and... | Medrad, Inc. | DXT | ||
| Z-0719-05 | Ultra/Phonic Conductivity Gel, 20 ml. Each unit is a foil to foil pouch. Product is... | Bard Access Systems, Inc. | ITX | ||
| Z-0718-05 | Intraoperative Ultrasound Cover Kit | Bard Access Systems, Inc. | ITX | ||
| Z-0717-05 | Site-Rite Sterile Ultrasound Probe Cover with Gel | Bard Access Systems, Inc. | ITX | ||
| Z-0716-05 | Site-Rite Sterile Needle Guide Kit - 21 Gauge | Bard Access Systems, Inc. | ITX | ||
| Z-0715-05 | Site-Rite Sterile Needle Guide Kit - 20 gauge | Bard Access Systems, Inc. | ITX | ||
| Z-0714-05 | Site-Rite Sterile Needle Guide Kit - 18 gauge | Bard Access Systems, Inc. | ITX | ||
| Z-0213-05 | Medtronic Midas Rex Legend Lubricant/ Diffuser Cartridge Catalog number PA100-A... | Medtronic Powered Surgical Solutions | HBB | ||
| Z-0199-05 | AccessAED (without audio record) Model Number: 9100-0100-0 | Access Cardiosystems, Inc. | MKJ | ||
| Z-0433-05 | Harvard 2 Syringe Pump manufactured for Rita Medical (OEM) Model Number 2005-001 | Harvard Clinical Technology | MEA | ||
| Z-0432-05 | Harvard 1 Single Channel Syringe Infusion Pump, P/N 2003-001 | Harvard Clinical Technology | MEA | ||
| Z-0431-05 | Harvard 2 Dual Channel Syringe Infusion Pump P/N 2001-001 | Harvard Clinical Technology | FRN | ||
| Z-0621-05 | Catheterization Kits containing Angiographic Syringes with rotator connector. | Abbott Medical | DQO | ||
| Z-0620-05 | Angiographic Syringe, 12 cc Palm Pad with Rotator Reservoir. | Abbott Medical | DQO | ||
| Z-0619-05 | Angiographic Syringe, 12 cc Thumb Ring with Rotator Non-Reservoir. | Abbott Medical | DQO | ||
| Z-0618-05 | Angiographic Syringe, 12 cc Thumb Ring with Rotator Reservoir. | Abbott Medical | DQO | ||
| Z-0617-05 | Angiographic Syringe, 10 cc Thumb Ring with Rotator Reservoir. | Abbott Medical | DQO | ||
| Z-0266-05 | CXP software for Cytomics FC500 Cytometer | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-0382-05 | Medication Bottle (U22-3), a component of the MicroAir Vibrating Mesh Nebulizer, Model... | Omron Healthcare Co., Ltd. | CAF | ||
| Z-0658-05 | DiaSorin ETI-EA-G assay kit Catalog No. 7570, lot # 113963C | Diasorin Inc. | LSE | ||
| Z-0927-05 | DiaSorin Anti-Cardiolipin IgA ELISA Kit, catalog no. 7800. Manufactured for: DiaSorin... | Diasorin Inc. | MID | ||
| Z-0189-05 | HomeChoice PRO and Yume Plus Automated Peritoneal Dialysis Systems; Manufactured for... | Baxter Healthcare Renal Div | FKX | ||
| Z-0188-05 | HomeChoice and Yume Automated Peritoneal Dialysis Systems; Manufactured for Baxter... | Baxter Healthcare Renal Div | FKX | ||
| Z-0268-05 | BD Phoenix ID/AST panels, catalog numbers 448007, 448008, 448400, 448452, 448459, 448600... | Becton Dickinson & Co | LON | ||
| Z-0454-05 | RunWay 6F Cardiovascular Guide Catheter. | Boston Scientific Corporation | DQY | ||
| Z-0371-05 | UniCel Dxl 800 Access Immunoassay Systems (Reaction Vessels). | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-0263-05 | Immulite 2500 Automated Immunoassay Analyzer, Human chorionic gonadotrpin (HCG) test... | Siemens Healthcare Diagnostics Inc. | DHA | ||
| Z-0310-05 | Brand name: NIM EMG Endotracheal Tube REF 82-29106, 82-29107... | Medtronic Xomed, Inc. | ETN | ||
| Z-1243-06 | Product is SoftPath ASCII Software Releases 2.3.0 and 4.3.7. The software is used in... | SCC Soft Computer | JQP | ||
| Z-0390-05 | Zimmer™ Orthopaedic Surgical Products, Disposable Cuff, 12'' (30cm), Dual Port, Single... | Zimmer Surgical SA | KCY | ||
| Z-0389-05 | Zimmer™ Orthopaedic Surgical Products, Disposable Cuff, 12'' (30cm), Single Port, Single... | Zimmer Surgical SA | KCY | ||
| Z-0388-05 | Zimmer™ Orthopaedic Surgical Products, Disposable Cuff, 42in (107cm), Single Port, Single... | Zimmer Surgical SA | KCY | ||
| Z-0217-05 | IMx HAVAB Controls are for In Vitro Diagnostic use. The kit is composed of 2 bottles of... | Abbott Diagnostic International, Ltd. | LOL | ||
| Z-0556-05 | The Triathlon Posteriorly Stabilized Femoral Component. | Howmedica Osteonics Corp | NPJ | ||
| Z-0261-05 | AMAX ThromboMAX with Calcium, 10x4ml vials. Catalog #T9902. Lyophilized extract of... | Trinity Biotech USA | GJS | ||
| Z-0179-05 | V. Mueller Pfister-Schwartz Stone Retriever 4-Wire Basket, Without Filiform Tip; a... | Medtronic, Inc. | FFL | ||
| Z-0185-05 | CrossAction Power Brushead Refills, Medium 2-Count Pack NDC: 0-69055-82448-1 | Gillette Research Institute | JEQ | ||
| Z-0184-05 | CrossAction Power Brushead Refills, Soft 2-Count Pack NDC:0-69055-82663-8 | Gillette Research Institute | JEQ | ||
| Z-0183-05 | Oral-B CrossAction PowerMAX Rechargeable Toothbrush, Medium NDC: 0-69055-83120-5 | Gillette Research Institute | JEQ | ||
| Z-0182-05 | Oral-B CrossAction PowerMAX Rechargeable Toothbrush, , Soft 4 Accent Colors: Blue, Pink... | Gillette Research Institute | JEQ | ||
| Z-0181-05 | Oral-B CrossAction Power Toothbrush, Medium (Battery Operated) Handle Colors: Blue... | Gillette Research Institute | JEQ | ||
| Z-0180-05 | Oral- B CrossAction Power Toothbrush , Soft (Battery Operated) Handle Colors: Blue... | Gillette Research Institute | JEQ | ||
| Z-0674-05 | Data reduction program written for a specific automated microtiter plate instrument... | Diasorin Inc. | MSV | ||
| Z-0262-5 | SYNCHRON Clinical Systems Lipase (LIPA) Reagent; Classification name: 862.1465 | Siemens Healthcare Diagnostics Inc. | CHI | ||
| Z-0260-05 | XPRT Therapy Mattress Systems: Model # 2950-000-000 with Dartex urethane-coated nylon... | Gaymar Industries, Inc. | IKZ | ||
| Z-0569-05 | ReliOn Insulin Syringe 0.5cc 30 Gauge 5/16 inch (8mm) Needle (U-100 Insulin). NDC... | Becton Dickinson & Co | FMF |