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-0032-04 | Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm... | Boston Scientific Corporation | LOX | ||
| Z-0031-04 | Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm... | Boston Scientific Corporation | LOX | ||
| Z-0030-04 | Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm... | Boston Scientific Corporation | LOX | ||
| Z-0047-04 | Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4.1 (excluding version... | OLYMPUS Corporation of the Americas | LMB | ||
| Z-1222-03 | BVS 5000t Bi-Ventricular Support System Transport/Backup Console Catalog Number: 0050-000 | Abiomed, Inc. | DSQ | ||
| Z-1156-04 | Vigil Lipid Control, Levels 1,2,3 and 4 for ApoB Reagent. | Siemens Healthcare Diagnostics Inc. | MSS | ||
| Z-0019-04 | CryoValve, Pulmonary Valve & Conduit SG | Artivion, Inc. | MIE | ||
| Z-1183-03 | Optima Large Poly Screw Driver | U&I America | MNI | ||
| Z-1182-03 | Optima Poly Screw Driver. | U&I America | MNI | ||
| Z-1186-03 | Alumina ceramic liner for acetabular shell. This is part of the Transcend... | Wright Medical Technology Inc | MRA | ||
| Z-1155-04 | Vigil Lipid Control Serum, Levels 1, 2 and 4 for LDL Cholesterol Reagent Part No... | Siemens Healthcare Diagnostics Inc. | MRR | ||
| Z-0070-04 | LySonix 2000 Ultrasonic Surgical Systems, MODEL NO. LY-2000. --- Old labeling... | Misonix, LLC | LFL | ||
| Z-1234-03 | Quick Care Starting Solution. The product is used for cleaning and disinfection of soft... | Alcon Laboratories | LPN | ||
| Z-0209-05 | Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0208-05 | Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0007-04 | Calculator/Data Processing Module for Clinical Use | CliniSys, Inc | JQP | ||
| Z-0162-04 | URO PRO Plus Digital Urology Imaging System | Medstone International Inc | JAA | ||
| Z-1294-03 | BBL (TM) LIM Broth, in glass slant tubes and packaged 100 tubes per carton, catalog... | Becton Dickinson & Co | JSD | ||
| Z-1208-03 | Software Versions V1.2R,or earlier for the Harvard 2, Dual Infusion Pump (P/N 2002-001) | Harvard Clinical Technology | FRN | ||
| Z-1214-03 | Diagnost 94 | Philips North America LLC | IZZ | ||
| Z-1213-03 | Diagnost 97 | Philips North America LLC | IZZ | ||
| Z-1212-03 | Diagnost 96 | Philips North America LLC | IZZ | ||
| Z-1299-03 | Integris Monitor Arm, model P997-03. | Hill-Rom Inc. | MHX | ||
| Z-1298-03 | Integris Monitor Arm, model P997-01. | Hill-Rom Inc. | MHX | ||
| Z-1195-03 | Sarns brand Retrograde Cardioplegia Cannula, 15 Fr, guidewire stylet, ribbed balloon... | Terumo Cardiovascular Systems Corporation | 74DWF | ||
| Z-1194-03 | Sarns brand Retrograde Cardioplegia Cannula, 15 Fr, guidewire stylet, smooth balloon... | Terumo Cardiovascular Systems Corporation | 74DWF | ||
| Z-1193-03 | Sarns brand Retrograde Cardioplegia Cannula, 13 Fr, malleable stylet, ribbed balloon... | Terumo Cardiovascular Systems Corporation | 74DWF | ||
| Z-1192-03 | Sarns brand Retrograde Cardioplegia Cannula, 13 Fr, steerable stylet, ribbed balloon... | Terumo Cardiovascular Systems Corporation | 74DWF | ||
| Z-1191-03 | Sarns brand Retrograde Cardioplegia Cannula, 17 Fr, malleable stylet, ribbed balloon... | Terumo Cardiovascular Systems Corporation | 74DWF | ||
| Z-1190-03 | Sarns brand Retrograde Cardioplegia Cannula, 17 Fr, steerable stylet, ribbed balloon... | Terumo Cardiovascular Systems Corporation | 74DWF | ||
| Z-0009-04 | Urology X-Ray System, Uroskop D1/D2/D3 - Hardware for Motor Drive | Siemens Medical Solutions USA, Inc. | JAA | ||
| Z-1145-03 | Integris Monitor Arm; model P997-04 | Hill-Rom Inc. | MHX | ||
| Z-0977-03 | Papsure, Speculite, Disposable light for vaginal illumination. 10 packets per box. | Watson Diagnostics Inc. | MPU | ||
| Z-1209-03 | VIDAS Chlamydia Assay (CHL) for In-Vitro Diagnostic Use Product Number: 30101 | bioMerieux, Inc. | LJC | ||
| Z-1295-03 | T2 Tibia Nail, Standard 9 x 300 mm, T2 Tibia System, Catalog No. 1822-0930S. | Howmedica Osteonics Corp | HSB | ||
| Z-1233-03 | Bard PEG Safety System ''Guidewire'' Reorder Number: 001928 | Conmed Endoscopic Technologies, Inc. | FMF | ||
| Z-1232-03 | Bard Ponsky PEG Safety System ''Pull'' Reoder Number: 001927 | Conmed Endoscopic Technologies, Inc. | FMF | ||
| Z-1231-03 | Bard Ponsky PEG Safety System ''Pull'' Reorder Number: 001925 | Conmed Endoscopic Technologies, Inc. | FMF | ||
| Z-1230-03 | Bard PEG Safety System ''Guidewire'' Reorder Number: 000930 | Conmed Endoscopic Technologies, Inc. | FMF | ||
| Z-0107-04 | 17 mm thickness only of a polyethelene insert, which sits on the top of a metal component... | Plus Orthopedics | KRO | ||
| Z-1189-03 | Boston Scientific Medi-Tech Imager II 5F Selective Angiographic Catheter | Boston Scientific Corporation | 74GBK | ||
| Z-1216-03 | McGhan Round Breast Implant, Saline-Filled BIOCELL textured. McGhan Shaped Breast... | Allergan | FWM | ||
| Z-1211-03 | Exactech Tibial Augmentation Block Trial Size 0, Exactech Tibial Tray Trial size 1 Delta... | Exactech, Inc. | LXH | ||
| Z-1239-03 | MDA Simplastin L, Product number 252555, 10 vials, 40 ml ea (400 test each), bioMerieux... | bioMerieux, Inc. | GJS | ||
| Z-0052-04 | Pulse Generator | Abbott Medical | DXY | ||
| Z-1219-03 | Immulite 2000 H. pylori IgG Kit lot 118 (L2KHQ6, 600 test size kit) | Siemens Healthcare Diagnostics Inc. | LYR | ||
| Z-1238-03 | Simplastin L, Prothrombin Time test, 10 vials (20 ml each), Product Number 259553... | bioMerieux, Inc. | GJS | ||
| Z-1146-03 | Exactech Tibial Offset Bushing (sizes 1, 2, 3, 4, & 5) Catalog Numbers 209-04-71... | Exactech, Inc. | LXH | ||
| Z-1185-03 | 1690 Ultratrace Series ECG Electrodes, clear tape ECG electrode with wet gel. This is a... | ConMed Corporation | DRX | ||
| Z-1184-03 | 1680 Invisatrace series ECG Electrodes, radiotranslucent clear tape ECG electrode with... | ConMed Corporation | DRX |