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-0788-2010 | Multi-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | ||
| Z-0787-2010 | Multi-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | ||
| Z-0786-2010 | Two-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | ||
| Z-0785-2010 | Multi-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | ||
| Z-0784-2010 | Percutaneous Sheath Introducer Kit with ARROWg+ard Blue (R) Sheath, Integral Hemostasis... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DYB | ||
| Z-0783-2010 | MAC (TM) Two Lumen Central Venous Access Kit with ARROWg+ard Blue (R) Access Device... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DYB | ||
| Z-0542-2010 | Polycarbonate prescription lenses (single vision, progressive, and trifocal) SKU #'s... | Luxottica North America Distribution LLC | HQY | ||
| Z-0397-2011 | BD Bioscience CD45 APC-H7 Analyte Specific Reagent, manufactured by BD Biosciences, San... | Becton, Dickinson and Company, BD Biosciences | MVU | ||
| Z-0810-2010 | LOCATOR Restorative Abutment, ILOA002, LOT 877423, Certain LOCATOR ABUTMENT, 4.1 mm(D) X... | ZimVie US Corp LLC | DZE | ||
| Z-0586-2010 | BD 30 ml Syringe; Luer-Lok Tip Catalog # 309650 Becton Dickinson, Franklin Lakes, NJ. | Becton Dickinson & Co | FMF | ||
| Z-0552-2010 | Philips Avalon Fetal Monitor FM 50 Catalog Number: M2705A. | Philips North America LLC | HGM | ||
| Z-0551-2010 | Philips Avalon Fetal Monitor FM 40 Catalog Number: M2704A. | Philips North America LLC | HGM | ||
| Z-0550-2010 | Philips Avalon Fetal Monitor FM 30 Catalog Number: M2703A. | Philips North America LLC | HGM | ||
| Z-0549-2010 | Philips Avalon Fetal Monitor FM 20 Catalog Number: M2702A. | Philips North America LLC | HGM | ||
| Z-0615-2010 | Haematokrit 20 Centrifuge with 2050 Rotor TYP #2014-01 and TYP#201424-01. Used for... | Hettich Instruments LP | GKG | ||
| Z-0614-2010 | Mikro 20 Centrifuge with 2076 Rotor TYP #2004 and TYP #2004-01. Used for the purpose... | Hettich Instruments LP | GKG | ||
| Z-0613-2010 | Haematokrit 24 Centrifuge with 2050 Rotor TYP #2075 and TYP #2075-01. Used for the... | Hettich Instruments LP | GKG | ||
| Z-0612-2010 | Mikro 12-24 Centrifuge with 2050 Rotor TYP #2070 and TYP 2070-01. Used for the... | Hettich Instruments LP | GKG | ||
| Z-2227-2010 | Main Power Supply Assembly (50 and 60 Hz) and AC Power cord assembly for hemodialysis... | Fresenius Medical Care Renal Therapies Group, LLC | FKP | ||
| Z-2226-2010 | Fresenius Granuflo 1 Mixer Dissolution Unit - Tested, and Granuflo Dissolution Tank... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | ||
| Z-2225-2010 | Fresenius 2008K, 2008K2 and 2008 K2@home Hemodialysis Machines, Manufactured by Fresenius... | Fresenius Medical Care Renal Therapies Group, LLC | KDI | ||
| Z-2224-2010 | Fresenius 2008H Dialysate Delivery Machine, Manufactured by Fresenius USA Inc., Walnut... | Fresenius Medical Care Renal Therapies Group, LLC | FKP | ||
| Z-0642-2010 | VNS Therapy Demipulse Generator, Model 103 and VNS Therapy Demipulse Duo Generator, Model... | LivaNova USA, Inc. | LYJ | ||
| Z-1015-2013 | Class II | Pyxis Anesthesia System Model 2000 (PAS 2000) Product Usage: The PAS 2000 is an... | CareFusion 303, Inc | BRY | |
| Z-0547-2010 | Vascular Solutions Pronto-Short Extraction Catheter. Model 5030. The PRONTO-Short... | Vascular Solutions LLC | DXE | ||
| Z-1309-2010 | 100-120V 2001 Pulse Oximeter with Mars Nurse Call, Refurbished - Dixtal owned... | Philips North America LLC | DQA | ||
| Z-1308-2010 | 100-120V 2001 Pulse Oximeter with Mars, Refurbished - Dixtal owned product. Intended... | Philips North America LLC | DQA | ||
| Z-1307-2010 | 515B Pulse Oximeter, RS232, Refurbished - Dixtal owned product. Intended use is to... | Philips North America LLC | DQA | ||
| Z-1306-2010 | 515B Pulse Oximeter, Refurbished - Dixtal owned product. Intended use is to provide... | Philips North America LLC | DQA | ||
| Z-1305-2010 | 100-120V Oxypleth - 520A Pulse Oximeter, Refurbished - Dixtal owned product. Intended... | Philips North America LLC | DQA | ||
| Z-1304-2010 | Spanish 100-120V 2001 Pulse Oximeter WI - Dixtal owned product. Intended use is to... | Philips North America LLC | DQA | ||
| Z-1303-2010 | 100-120V 2001 Pulse Oximeter with Mars Nurse Call - Dixtal owned product. Intended use... | Philips North America LLC | DQA | ||
| Z-1302-2010 | 100-120V 2001 Pulse Oximeter With Mars - Dixtal owned product. Intended use is to... | Philips North America LLC | DQA | ||
| Z-1301-2010 | Spanish 100-120V 515B Pulse Oximeter - Dixtal owned product. Intended use is to... | Philips North America LLC | DQA | ||
| Z-1300-2010 | 100-120V 515B with RS-232 Pulse Oximeter - Dixtal owned product. Intended use is to... | Philips North America LLC | DQA | ||
| Z-1299-2010 | French 100-120V 515B Pulse Oximeter - Dixtal owned product. Intended use is to provide... | Philips North America LLC | DQA | ||
| Z-1298-2010 | 515B Pulse Oximeter - Dixtal owned product. Intended use is to provide continuous... | Philips North America LLC | DQA | ||
| Z-1297-2010 | Span 100-120V 520A - OxyPleth Pulse Oximeter - Dixtal owned product. Intended use is... | Philips North America LLC | DQA | ||
| Z-1296-2010 | Japanese 100-120V Oxypleth - 520A Pulse Oximeter- Dixtal owned product. Intended use... | Philips North America LLC | DQA | ||
| Z-1295-2010 | 100-120V Oxypleth - 520A Pulse Oximeter - Dixtal owned product. Intended use is to... | Philips North America LLC | DQA | ||
| Z-1294-2010 | Tidal Wave - 615, Refurbished, Respironics/Philips product. Intended use of the... | Philips North America LLC | CCK | ||
| Z-1293-2010 | 100-200V NICO, 7300 Cardio Mgt System, Refurbished, Respironics/Philips product. The... | Philips North America LLC | CCK | ||
| Z-1292-2010 | Refurbished Tidal Wave SP 715, Refurbished, Respironics/Philips product. Intended use... | Philips North America LLC | DQA | ||
| Z-1291-2010 | REFURBISHED TIDALWAVE SP 710, REFURBISHED, Respironics/Philips product. Intended use... | Philips North America LLC | BZC | ||
| Z-1290-2010 | Resp Profile Monitor, 8100 Cosmo+, Refurbished, Respironics/Philips product. Used to... | Philips North America LLC | DQA | ||
| Z-1289-2010 | Tidal Wave 610, Refurbished, Respironics/Philips product. Intended use of the monitors... | Philips North America LLC | CCK | ||
| Z-1288-2010 | Transcutaneous C02 & 02 Monitor - 860, Refurbished, Respironics/Philips product. Used... | Philips North America LLC | LKD | ||
| Z-1287-2010 | Cosmo Model 7100 SP02 & ETC02 Monitor, Refurbished, Respironics/Philips... | Philips North America LLC | DQA | ||
| Z-1286-2010 | 100-120V Capnogard 1265, Refurbished, Respironics/Philips product. Intended to be used... | Philips North America LLC | CCK | ||
| Z-1285-2010 | NIC02 Model 7600 Refurbished, Respironics/Philips product. Intended use is cardiac... | Philips North America LLC | CCK |