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-0782-04 | AxSYM Troponin-I Reagent Kit, list 3C29-20, 100 test kit; Abbott Laboratories, Abbott... | Abbott Medical | MMI | ||
| Z-0815-04 | Medtronic Trillium Affinity NT Integrated-CVR Membrance Oxygenator and Cardiotomy Venous... | Medtronic Perfusion Systems | DTZ | ||
| Z-0900-04 | Advantx 1 SC Model 36006617 Angiographic X-ray System | GE Healthcare | IZI | ||
| Z-0899-04 | Advantx 1 LC2 Model 2105657 Angiographic X-ray System | GE Healthcare | IZI | ||
| Z-0898-04 | Advantx 1 LC2 Model 45562281 Angiographic X-ray System | GE Healthcare | IZI | ||
| Z-0897-04 | Advantx 1 LC1 Model 45258230 Angiographic X-ray System | GE Healthcare | IZI | ||
| Z-0896-04 | Advantx 1 LC1 Model 46-279781P1 Angiographic X-ray System | GE Healthcare | IZI | ||
| Z-0775-04 | CryoValve, Aortic Valve & Conduit | Artivion, Inc. | MIE | ||
| Z-0774-04 | CryoValve, Pulmonary Valve & Conduit | Artivion, Inc. | MIE | ||
| Z-0958-05 | AcQSim X-Ray Computed Tomography Scanners. These scanners were sold under the brand... | Philips North America LLC | JAK | ||
| Z-0957-05 | Ultra Z 90 X-Ray Computed Tomography Scanners. These scanners were sold under the brand... | Philips North America LLC | JAK | ||
| Z-0781-04 | ARCHITECT CA 19-9 Reagent Kit, list 6C04-20 (1 x 100 tests) and 6C04-25 (4 x 100 tests)... | Abbott Medical | NIG | ||
| Z-0846-04 | AEROSET Analyzer System, Model 9D05-01, distributed by Abbott Laboratories Diagnostic... | Abbott Medical | JJE | ||
| Z-0890-04 | KCI Underbed Inverter, Accessory to Powered Flotation Therapy Bed, manufactured by... | KCI USA, Inc. | IOQ | ||
| Z-0889-04 | Burke Bariatric Bed, manufactured by Kinetic Concepts, Inc., San Antonio, TX, model... | KCI USA, Inc. | FNL | ||
| Z-0888-04 | KCI Therapulse II Air Suspension Therapy Bed, manufactured by Kinetic Concepts, Inc., San... | KCI USA, Inc. | INX | ||
| Z-0887-04 | KCI TriaDyne Proventa Critial Care Therapy System, manufactured by Kinetic Concepts... | KCI USA, Inc. | IKZ | ||
| Z-1075-04 | The product is a stainless steel stent mounted on a PTA balloon delivery device. The... | Orbusneich Medical, Inc. | MEW | ||
| Z-1092-04 | Introcan Safety IV Catheter 22G x 1'' PUR with Wings. The affected catalogs and lot... | B Braun Medical Inc | FOZ | ||
| Z-0818-04 | ARCHTECT System RS-232 Manual, product list number 06F71-04, for the ARCHITECT i2000... | Abbott Medical | JJE | ||
| Z-0849-04 | Prima III TotalSENSE Torso Coil (Body Array Coil), labeled as Manufactured by: USA... | GE Healthcare Coils | LNH | ||
| Z-0842-04 | Product in clear plastic pouch labeled: Boston Scientific MEDI-TECH *** VASCULAR DILATOR... | Boston Scientific Corporation | DRE | ||
| Z-0769-04 | Clinical Chemistry Uric Acid; LN 7D76-20 | Abbott Medical | CDO | ||
| Z-1031-04 | Computed Tomography, Models TSX-101A and TSX-021A. | Canon Medical Systems USA, Inc. | JAK | ||
| Z-1004-04 | M/DN Intramedullary Fixation Humeral Nail | Zimmer GmbH | HSB | ||
| Z-0768-04 | Zimmer brand Coonrad/Morrey total elbow interchangeable ulnar assembly, small, right, 3... | Zimmer GmbH | JDC | ||
| Z-0767-04 | Zimmer brand Coonrad/Morrey total elbow interchangeable ulnar assembly, small, left, 3... | Zimmer GmbH | JDC | ||
| Z-0765-04 | QPC1680 Quick Connect, for Pentax 30/40/K Series Two-Channel GI Endoscopes, in the Steris... | STERIS Corporation | MED | ||
| Z-0761-04 | Hill-Rom brand TotalCare bed system; model P1900 -remanufactured only. | Hill-Rom Inc. | LLI | ||
| Z-1051-04 | Clinitek 50 Urine Chemistry Analyzer; Product codes 6509C, 6513K, 6514C, 6515C, 6516F and... | Medrad, Inc. | KQO | ||
| Z-0090-2011 | SoftPath GUI version 3.17.6.3.1. SCC Soft Computer 34350 US Highway 19 N, Palm Harbor, FL... | SCC Soft Computer | LNX | ||
| Z-0806-04 | Guidant Rapido 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length... | Boston Scientific Corporation | DQR | ||
| Z-0805-04 | Guidant Rapido 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length... | Boston Scientific Corporation | DQR | ||
| Z-0804-04 | Guidant Rapido 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Lenght... | Boston Scientific Corporation | DQR | ||
| Z-0803-04 | Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall... | Boston Scientific Corporation | DQR | ||
| Z-0802-04 | Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall... | Boston Scientific Corporation | DQR | ||
| Z-0801-04 | Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall... | Boston Scientific Corporation | DQR | ||
| Z-0800-04 | Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall... | Boston Scientific Corporation | DQR | ||
| Z-0799-04 | Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall... | Boston Scientific Corporation | DQR | ||
| Z-0798-04 | Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall... | Boston Scientific Corporation | DQR | ||
| Z-0772-04 | Codman Holter Salmon Rickham Reservoir with Ventricular Catheter Catalog Number: 82-1617 | Cerenovus, Inc. | HCA | ||
| Z-0797-04 | Guidant Rapido 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length... | Boston Scientific Corporation | DQR | ||
| Z-0796-04 | Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall... | Boston Scientific Corporation | DQR | ||
| Z-0795-04 | Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall... | Boston Scientific Corporation | DQR | ||
| Z-0794-04 | Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall... | Boston Scientific Corporation | DQR | ||
| Z-0793-04 | Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall... | Boston Scientific Corporation | DQR | ||
| Z-0792-04 | Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall... | Boston Scientific Corporation | DQR | ||
| Z-0791-04 | Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall... | Boston Scientific Corporation | DQR | ||
| Z-0743-04 | FreshLook Toric, Daily wear soft (hydrophilic) contact lens, BC: Median, DIA: 14.5... | Alcon Laboratories | LPM | ||
| Z-0742-04 | FreshLook Enhancers, Daily wear soft (hydrophilic) contact lens, BC: Median, DIA: 14.5... | Alcon Laboratories | LPM |