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-2347-2015 | Class II | Merge Hemo, 9.10, 9.20.0, 9.20.1,9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 with Massimo... | Merge Healthcare Incorporated | DQK | |
| Z-1243-2015 | Class II | DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2 | iCAD, Inc. | LLZ | |
| Z-1070-2015 | Class II | Aquarius iNtuition Client Viewer. Findings Workflow module, RECIST 1.1: Picture Archiving... | Terarecon, Inc. | LLZ | |
| Z-1282-2015 | Class II | Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to... | Siemens Medical Solutions USA, Inc. | IYE | |
| Z-1083-2015 | Class II | Hemodialysis Catheters and PICCs: Product identification: MCDLTSL24P (SF X 24CM LT... | Medical Components, Inc. | LFJ | |
| Z-1118-2015 | Class II | HARMONIC ACE Curved Shears Instructions for Use, 8MM, IS2000/IS3000; for use with the da... | Intuitive Surgical, Inc. | NAY | |
| Z-1117-2015 | Class II | HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200; for use with the da Vinci... | Intuitive Surgical, Inc. | NAY | |
| Z-1679-2017 | Class II | Non-Sterile Double DIN to DIN "Y" Connector, Product Usage: Extension for connecting... | Molded Products Inc | KOC | |
| Z-1321-2015 | Class II | ADVIA Chemistry Systems Drug Calibrator I; For in vitro diagnostic use in the calibration... | Siemens Healthcare Diagnostics Inc. | JIX | |
| Z-1222-2015 | Class II | KimVent Wet Pak, Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile... | Halyard Health | BSY | |
| Z-1221-2015 | Class II | KimVent Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile... | Halyard Health | BSY | |
| Z-1220-2015 | Class II | KimVent Closed Suction System for Adults, Double Swivel Elbow, 12 Fr., Sterile... | Halyard Health | BSY | |
| Z-1131-2015 | Class I | HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use as a... | HeartWare, Inc. | DSQ | |
| Z-1119-2015 | Class II | Artis One; The Artis One is an angiography system developed for diagnostic interventional... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-1126-2015 | Class II | BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA... | CME America, LLC | FRN | |
| Z-1215-2015 | Class II | The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system. An... | Brainlab, Inc. | OLO | |
| Z-0011-2018 | Class II | ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the label is... | Abbott Medical | JJE | |
| Z-2720-2016 | Class II | ReliaMed Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each... | Advanced Medical Solutions Limited | FRO | |
| Z-2719-2016 | Class II | ReliaMed Silver Alginate/CMC. Each dressing is packed in a pouch (primary packaging)... | Advanced Medical Solutions Limited | FRO | |
| Z-1580-2015 | Class II | ViewRay System, Radiation Therapy System | Viewray Systems, Inc. | IYE | |
| Z-1289-2015 | Class III | N Latex IgM; In-vitro diagnostic reagent for the quantitative determination of IgM in... | Siemens Healthcare Diagnostics Inc. | CFN | |
| Z-1478-2015 | Class II | 6" Trifurcated set with Bionectors, Product Code: BN-944 Accessory device used to... | Vygon Mfg | FPA | |
| Z-1477-2015 | Class II | 4" Trifurcated set with Bionectors and check valves, Product Code: BN-3082CV and... | Vygon Mfg | FPA | |
| Z-1476-2015 | Class II | Bifurcated set with check vales and Bionectors, Product Code: BN-2082CV Accessory device... | Vygon Mfg | FPA | |
| Z-1475-2015 | Class II | 7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to... | Vygon Mfg | FPA | |
| Z-1474-2015 | Class II | 7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to... | Vygon Mfg | FPA | |
| Z-1473-2015 | Class II | 7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1 Accessory device... | Vygon Mfg | FPA | |
| Z-1472-2015 | Class II | 8" Standard Bore Ext Set, Product Code: BN-481 Accessory device used to administer... | Vygon Mfg | FPA | |
| Z-1471-2015 | Class II | 4" Microbore T-Port Set, Product Code: BN-448 Accessory device used to administer medical... | Vygon Mfg | FPA | |
| Z-1470-2015 | Class II | 4" Microbore Trifurcated Ext set, Product Code: BN-308 Accessory device used to... | Vygon Mfg | FPA | |
| Z-1469-2015 | Class II | 4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory device used... | Vygon Mfg | FPA | |
| Z-1468-2015 | Class II | Bifircated Extension Set, Product Code: BN-828 Accessory device used to administer... | Vygon Mfg | FPA | |
| Z-1467-2015 | Class II | 6" Trifurcated Extension Set, Product Code: AMS-375-1 Accessory device used to administer... | Vygon Mfg | FPA | |
| Z-1048-2015 | Class II | da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45... | Intuitive Surgical, Inc. | NAY | |
| Z-1139-2015 | Class II | Storm Series Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power... | Invacare GmbH | ITI | |
| Z-1138-2015 | Class II | FDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs... | Invacare GmbH | ITI | |
| Z-1137-2015 | Class II | TDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs... | Invacare GmbH | ITI | |
| Z-1223-2015 | Class II | Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for... | Mallinckrodt Manufacturing LLC | MRN | |
| Z-1109-2015 | Class II | AQUAPAK 640 SW, 650ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an... | Teleflex Medical | BTT | |
| Z-1108-2015 | Class II | AQUAPAK 340 SW, 340ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an... | Teleflex Medical | BTT | |
| Z-1107-2015 | Class II | ADAPTOR, 040 HUM, INTL. Product Usage: The Humidifier Adaptor is an accessory which... | Teleflex Medical | BTT | |
| Z-1106-2015 | Class II | AQUAPAK 640 SW, 650ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an... | Teleflex Medical | BTT | |
| Z-1105-2015 | Class II | AQUAPAK 640 SW, 650ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an... | Teleflex Medical | BTT | |
| Z-1104-2015 | Class II | AQUAPAK SW/EAU STERILE, 650 ML W/ADAPTOR. Product Usage: The Humidifier Adaptor is an... | Teleflex Medical | BTT | |
| Z-1103-2015 | Class II | AQUAPAK 640 SW, 650ML W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is an... | Teleflex Medical | BTT | |
| Z-1102-2015 | Class II | AQUA 540 SW, 540 W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory... | Teleflex Medical | BTT | |
| Z-1101-2015 | Class II | AQUAPAK 340 SW, 340, ML W/040, ADAPTOR, JAPA. Product Usage: The Humidifier Adaptor is... | Teleflex Medical | BTT | |
| Z-1100-2015 | Class II | AQUAPAK 340 SW, 340 ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an... | Teleflex Medical | BTT | |
| Z-1099-2015 | Class II | AQUAPAK SW/EAU STERILE, 340 ML W/ADAPTOR Product Usage: The Humidifier Adaptor is an... | Teleflex Medical | BTT | |
| Z-1098-2015 | Class II | AQUAPAK 340 SW, 340 ML W/040B ADAPTOR, BRI Product Usage: The Humidifier Adaptor is an... | Teleflex Medical | BTT |