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-1630-2015 | Class II | Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic... | CooperSurgical, Inc. | NLM | |
| Z-1545-2015 | Class II | Insorb Subcuticular Skin Stapler. INSORB staples are made from an absorbable copolymer... | Incisive Surgical, Inc. | GDW | |
| Z-1445-2015 | Class II | Artis Q/ Q zen systems; Artis Q/ Q zen systems are dedicated angiography systems... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-1691-2015 | Class II | SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and... | Biosense Webster Inc | OAE | |
| Z-1523-2015 | Class II | Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint... | Zimmer GmbH | LXH | |
| Z-1449-2015 | Class II | Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control... | Hansen Medical, Inc. | DXX | |
| Z-1446-2015 | Class II | LOW PROFILE NON-LOCK SCREW; 2.7mm x 22 mm; REF 131227222; LOT RM105E. Provides the... | Zimmer GmbH | LXT | |
| Z-2205-2015 | Class II | Head Holder shipped with Ingenuity CT Computed Tomography X-ray Systems | Philips North America LLC | JAK | |
| Z-2204-2015 | Class II | Head Holder shipped with Ingenuity Core 128 Computed Tomography X-ray Systems. Intended... | Philips North America LLC | JAK | |
| Z-2191-2015 | Class II | American Catheter / Cholangiogram Catheter 9100 Series. | American Catheter Corp | GBZ | |
| Z-2203-2015 | Class II | Head Holder shipped with Ingenuity Core Computed Tomography X-ray Systems. Intended to... | Philips North America LLC | JAK | |
| Z-1535-2015 | Class II | CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage: Provides... | Biocare Medical LLC | NJT | |
| Z-1356-2015 | Class II | Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Usage: The... | Medtronic, Inc. | DTE | |
| Z-1447-2015 | Class II | Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty 14g x 16cm (22mm)... | Bard Peripheral Vascular Inc | KNW | |
| Z-2295-2019 | Class II | Brand Name Burn Navigator Model Numbers: Catalog 1120, Burn Navigator H2 Catalog 1125... | Arcos, Inc | PDT | |
| Z-1657-2015 | Class II | Ingenuity CT. Computed Tomography X-ray systems intended to produce cross-sectional... | Philips North America LLC | JAK | |
| Z-1656-2015 | Class II | Brilliance iCT. Computed Tomography X-ray systems intended to produce cross-sectional... | Philips North America LLC | JAK | |
| Z-1655-2015 | Class II | Brilliance CT 6 Air. Computed Tomography X-ray systems intended to produce... | Philips North America LLC | JAK | |
| Z-1654-2015 | Class II | Brilliance CT 10 Air. Computed Tomography X-ray systems intended to produce... | Philips North America LLC | JAK | |
| Z-1653-2015 | Class II | Brilliance CT 16 Air. Computed Tomography X-ray systems intended to produce... | Philips North America LLC | JAK | |
| Z-1652-2015 | Class II | Brilliance CT 16 Water. Computed Tomography X-ray systems intended to produce... | Philips North America LLC | JAK | |
| Z-1651-2015 | Class II | Brilliance CT 16 Power. Computed Tomography X-ray systems intended to produce... | Philips North America LLC | JAK | |
| Z-1650-2015 | Class II | Brilliance CT 40. Computed Tomography X-ray systems intended to produce cross-sectional... | Philips North America LLC | JAK | |
| Z-1649-2015 | Class II | Brilliance CT 64. Computed Tomography X-ray systems intended to produce cross-sectional... | Philips North America LLC | JAK | |
| Z-1648-2015 | Class II | Brilliance CT Big Bore Oncology. Computed Tomography X-ray systems intended to produce... | Philips North America LLC | JAK | |
| Z-1647-2015 | Class II | MX8000 Dualv. EXP, 728130. Computed Tomography X-ray systems intended to produce... | Philips North America LLC | JAK | |
| Z-1412-2015 | Class II | Natus neoBLUE blanket LED Phototherapy system which includes the following items: 006224... | Natus Medical Incorporated | LBI | |
| Z-1393-2015 | Class II | da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek... | Intuitive Surgical, Inc. | KKX | |
| Z-1392-2015 | Class II | da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek... | Intuitive Surgical, Inc. | KKX | |
| Z-1391-2015 | Class II | da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack. Microtek Medical... | Intuitive Surgical, Inc. | KKX | |
| Z-1390-2015 | Class II | da Vinci S Surgical System IS2000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek... | Intuitive Surgical, Inc. | KKX | |
| Z-1389-2015 | Class II | da Vinci S Surgical System IS2000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek... | Intuitive Surgical, Inc. | KKX | |
| Z-1388-2015 | Class II | da Vinci S / Si Surgical System IS2000 / IS3000, Camera Arm Drape, 20 Pack. Microtek... | Intuitive Surgical, Inc. | KKX | |
| Z-1387-2015 | Class II | da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek... | Intuitive Surgical, Inc. | KKX | |
| Z-1386-2015 | Class II | da Vinci Si Surgical System IS3000, Monitor Drape, 20 Pack. Microtek Medical Equipment... | Intuitive Surgical, Inc. | KKX | |
| Z-1385-2015 | Class II | da Vinci Si Surgical System IS3000, Camera Head Drape, 20 Pack. Microtek Medical... | Intuitive Surgical, Inc. | KKX | |
| Z-1384-2015 | Class II | da Vinci S Surgical System IS2000, Vision-Cart Monitor Drape, 20 Pack. Microtek Medical... | Intuitive Surgical, Inc. | KKX | |
| Z-1383-2015 | Class II | da Vinci S Surgical System IS2000, Patient-Cart Monitor Drape, 20 Pack. Microtek Medical... | Intuitive Surgical, Inc. | KKX | |
| Z-1382-2015 | Class II | da Vinci S Surgical System IS2000, Camera Drape, 20 Pack. Microtek Medical Equipment... | Intuitive Surgical, Inc. | KKX | |
| Z-1381-2015 | Class II | da Vinci S Surgical System IS2000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment... | Intuitive Surgical, Inc. | KKX | |
| Z-1380-2015 | Class II | da Vinci S Surgical System IS2000, Arm Drape, 20 Pack. Microtek Medical Equipment... | Intuitive Surgical, Inc. | KKX | |
| Z-1464-2015 | Class II | DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product Usage: The... | Diasorin Inc. | MLM | |
| Z-1454-2015 | Class II | STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus... | DiaSorin Molecular LLC | OYP | |
| Z-0737-2016 | Class II | Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F... | Bard Peripheral Vascular Inc | DTK | |
| Z-2764-2015 | Class III | Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE... | Horiba Instruments Incorporated | LBR | |
| Z-1598-2015 | Class II | Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX... | Philips North America LLC | KPS | |
| Z-1560-2015 | Class II | PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 The PowerLoc MAX Safety... | Bard Access Systems, Inc. | FPA | |
| Z-1452-2015 | Class II | Integra Flowable Wound Matrix Size 3cc 1 unit/box single use, sterile device Rx Only... | Integra LifeSciences Corporation | KGN | |
| Z-1557-2015 | Class II | Introduction Pack. A device inserted into an endotracheal tube to aid in the intubation... | Vital Signs Colorado, Inc. | BSR | |
| Z-1556-2015 | Class II | CareFusion Vital Signs LightWand Stylet. A device inserted into an endotracheal tube to... | Vital Signs Colorado, Inc. | BSR |