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-0049-2007 | DynaRad Phantom Portable X-Ray System; Del Medical Imaging Corporation, 11550 West King... | Del Medical, Inc. | IZL | ||
| Z-0048-2007 | Fabius GS Anesthesia Machine. Catalog number 8604699 | Draeger, Inc. | BSZ | ||
| Z-0159-2007 | Jostra HL-20 Heart Lung Machine - guiding pins | Maquet Cardiovascular Us Sales, LLC | DTQ | ||
| Z-0397-2007 | Portrait PSR3 System, an electro-surgical device used in dermatological applications | Rhytec Inc. | GEI | ||
| Z-0636-2007 | Brilliance CT System, Big Bore Configuration, Model #728243. (version 2.2.1) | Philips North America LLC | |||
| Z-0199-2007 | Eridan Automated Slide Stainer and Support Cart, REF E300 and E300SC1, Dako Colorado... | Dako Colorado, Inc. | KPA | ||
| Z-0257-2007 | AMPLATZER TorqVue (cardiac septal occluder) Delivery System with Pusher Catheter Order... | Abbott Medical | GBK | ||
| Z-0256-2007 | Amplatzer Cardiac Septal Occluder delivery system Exchange Systems labeled as follows... | Abbott Medical | GBK | ||
| Z-0255-2007 | Amplatzer Cardiac Septal Occluder Delivery Systems labeled as follows: a) AMPLATZER... | Abbott Medical | GBK | ||
| Z-0168-2007 | Modularis URO urological table Model number 5531012 | Siemens Medical Solutions USA, Inc. | MMZ | ||
| Z-0269-2007 | Guidant CONTAK RENEWAL 3 RF (models H210, H215), CONTAK RENEWAL 3 RF HE (models H217... | Boston Scientific Corporation | LWP | ||
| Z-0042-2007 | OEC 9900 Elite Fluoroscopy System, Catalog No. 887208 and 887210, GE OEC Medical Systems... | GE Healthcare | JAA | ||
| Z-0541-2008 | Discovery XT, Slide Staining System, Catalog Number: N750-DISXT-FS, Ventana Medical... | Ventana Medical Systems Inc | KPA | ||
| Z-0540-2008 | Discovery, Slide Staining System, Catalog Number: N750-DIS-FS, Ventana Medical Systems... | Ventana Medical Systems Inc | KPA | ||
| Z-0539-2008 | Benchmark LT, Slide Staining System, Catalog Number: N750-BMKLT-FS, Ventana Medical... | Ventana Medical Systems Inc | KPA | ||
| Z-0538-2008 | Benchmark XT, Slide Staining System, Catalog Number: N750-BMKXT-FS, Ventana Medical... | Ventana Medical Systems Inc | KPA | ||
| Z-0537-2008 | Benchmark, Slide Staining System, Catalog Number: N750-BMK-FS, Ventana Medical Systems... | Ventana Medical Systems Inc | KPA | ||
| Z-0453-2007 | LifeScan brand One Touch -Sure Step Pro- Blood Glucose Monitoring System Test Strips, 50... | Lifescan, Inc. | CGA | ||
| Z-0452-2007 | LifeScan brand OneTouch Sure Step- Blood Glucose Monitoring System Test Strips, 50 strips... | Lifescan, Inc. | NBW | ||
| Z-0222-2007 | NOW Legionella Urinary Antigen Test. 22 test kit. For In Vitro Diagnostic Use Product... | Abbott Diagnostics Scarborough, Inc. | MJH | ||
| Z-0259-2007 | Veris Invasive Blood Pressure Interface Cables-Part # 3010478. The product is an... | Medrad, Inc. | MWI | ||
| Z-0258-2007 | Invasive Blood Pressure Interface Cables: a) Medrad 9500 Multigas monitor for MRI... | Medrad, Inc. | MWI | ||
| Z-0443-2007 | TruFit BGS Plug Size Code Blue, 9mm; quantity 1; Part #600-001-05; product labeled as... | Smith & Nephew, Inc. | MQV | ||
| Z-0442-2007 | TruFit BGS Plug Size Code Red, 7mm; quantity 1; Part #600-001-03; product labeled as... | Smith & Nephew, Inc. | MQV | ||
| Z-0441-2007 | TruFit CB Plug Size Code Blue, 9mm; quantity 1; Part #605-001-05; product labeled as... | Smith & Nephew, Inc. | MQV | ||
| Z-0287-2007 | Implantable Vascular Access System -- Infusion Ports with Silicone Rubber... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJT | ||
| Z-0286-2007 | Implantable Vascular Access System -- Infusion Ports with Silicone Rubber... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJT | ||
| Z-0285-2007 | Implantable Vascular Access System -- Infusion Ports with Silicone Rubber... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJT | ||
| Z-0284-2007 | Implantable Vascular Access System -- Infusion Ports with Silicone Rubber... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJT | ||
| Z-0283-2007 | Implantable Vascular Access System -- Infusion Ports with Silicone Rubber... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJT | ||
| Z-0282-2007 | Implantable Vascular Access system --Infusion Ports with Silicone Rubber... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJT | ||
| Z-0281-2007 | Implantable Vascular Access system -- Infusion Ports with Silicone Rubber... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJT | ||
| Z-0280-2007 | Implantable Vascular Access system -- Infusion Ports with Silicone Rubber... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJT | ||
| Z-0279-2007 | Implantable Vascular Access System -- Infusion Ports with Silicone Rubber... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJT | ||
| Z-0278-2007 | Implantable Vascular Access System -- Infusion Ports with Silicone Rubber... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJT | ||
| Z-0277-2007 | Implantable Vascular Access System -- Infusion Ports with Silicone Rubber... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJT | ||
| Z-0276-2007 | Implantable Vascular Access system -- Infusion Ports with Silicone Rubber... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJT | ||
| Z-0275-2007 | Implantable Vascular Access system -- Infusion Ports with Silicone Rubber... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJT | ||
| Z-0274-2007 | Implantable Vascular Access System -- Infusion Ports with Silicone Rubber... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJT | ||
| Z-0273-2007 | Implantable Vascular Access System -- Infusion Ports with Silicone Rubber... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJT | ||
| Z-0272-2007 | Implantable Vascular Access System -- Infusion Ports with Silicone Rubber... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJT | ||
| Z-0271-2007 | Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Ref... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJT | ||
| Z-0270-2007 | Implantable Vascular Access System -- Infusion Ports with Silicone Rubber catheter... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJT | ||
| Z-0440-2007 | TruFit CB Plug Size Code Red, 7mm; quantity 1; Part #605-001-03; product labeled as... | Smith & Nephew, Inc. | MQV | ||
| Z-0068-2007 | Apligraf (Graftskin) | Organogenesis, Inc. | MGR | ||
| Z-0198-2007 | StatSpin Express 3 Centrifuge with RTX8 Rotor Model: M502 | StatSpin, Inc., dba Iris Sample Processing | JQC | ||
| Z-0245-2008 | Clearview hCG Combo Waived for urine & Moderate for serum, Wampole Laboratories, ABI List... | Applied Biotech Inc | JHI | ||
| Z-0244-2008 | Clearview hCG Combo with Reference Line, Wampole Laboratories, ABI List No/Product No... | Applied Biotech Inc | JHI | ||
| Z-0189-2007 | Doc-U-Dose Prescription Management System, Item 8-PKIT. The product is packaged and... | Eatonform Inc | NQX | ||
| Z-0156-2007 | DermaStyle Chroma 2-blue and red light device indicated to be used in treating skin... | Lumiport, LLC | MOQ |