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-0613-2019 | Class II | AIA-360 Analyzer is capable of performing two methods of immunoassay: an immunoenzymetric... | Tosoh Bioscience Inc | KHO | |
| Z-2099-2017 | Class I | Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular Graft... | Cook Medical LLC | MIH | |
| Z-2068-2017 | Class II | Regenerex Patella RGX 3 PEG SER A PATELLA 28MM RGX 3 PEG SER A PATELLA 31MM RGX 3 PEG SER... | Zimmer GmbH | MBH | |
| Z-2036-2017 | Class II | PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH, SST PLATE... | Smith & Nephew, Inc. | HRS | |
| Z-2039-2017 | Class I | NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T, 1012448-12T, 1012448-15T... | Abbott Vascular | LOX | |
| Z-2038-2017 | Class I | NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15... | Abbott Vascular | LOX | |
| Z-2037-2017 | Class I | NC Trek RX Coronary Dilatation Catheter, Part No. 1012448-06, 1012448-08, 1012448-12... | Abbott Vascular | LOX | |
| Z-1898-2017 | Class I | Wingman 35 Crossing Catheter, 65cm, Model Numbers: WGM35065US WGM35065CE WGM35090US WGM... | ReFlow Medical, Inc | DQY | |
| Z-1822-2017 | Class II | The following systems are only affected if a Laird chiller is installed (11NC... | Philips North America LLC | OWB | |
| Z-1821-2017 | Class II | UNIQ: UNIQ FD10 722026; UNIQ FD10/10 722027; UNIQ FD20/10 biplane 722029; UNIQ FD10 OR... | Philips North America LLC | OWB | |
| Z-1820-2017 | Class II | Allura Xper Release 8.2 (Laird chiller is always installed); Allura Xper FD10 722026... | Philips North America LLC | OWB | |
| Z-2611-2017 | Class II | Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge | Siemens Healthcare Diagnostics Inc. | JLW | |
| Z-2610-2017 | Class II | Dimension Vista Prolactin (PRL) Flex reagent cartridge | Siemens Healthcare Diagnostics Inc. | CFT | |
| Z-2609-2017 | Class II | Dimension Vista Ferritin (FERR) Flex reagent cartridge | Siemens Healthcare Diagnostics Inc. | DBF | |
| Z-2608-2017 | Class II | Dimension Vista Estradiol (E2) Flex reagent cartridge | Siemens Healthcare Diagnostics Inc. | CHP | |
| Z-2607-2017 | Class II | Dimension Vista Digoxin (DIGXN) Flex reagent cartridge | Siemens Healthcare Diagnostics Inc. | KXT | |
| Z-2606-2017 | Class II | Dimension Troponin 1 (TNI) Flex reagent cartridge | Siemens Healthcare Diagnostics Inc. | MMI | |
| Z-2049-2017 | Class II | Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular Analyzer... | Roche Diagnostics GmbH | JJE | |
| Z-1830-2017 | Class II | Proteus 235, Proton Therapy System | Ion Beam Applications S.A. | LHN | |
| Z-2308-2017 | Class II | ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2307-2017 | Class II | ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2306-2017 | Class II | Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue(R)... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2305-2017 | Class II | ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit The Arrow(r) CVC is... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2304-2017 | Class II | Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostasis... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2303-2017 | Class II | ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit The large-bore multiple-lumen catheter... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2302-2017 | Class II | Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions The Arrow... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2301-2017 | Class II | QuickFlash(R) Radial Artery/Arterial Line Catheterization Kit The Arrow Arterial... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2300-2017 | Class II | Arterial Catheterization Kit The Arrow Arterial Catheterization device permits access to... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2299-2017 | Class II | Arterial Catheterization Kit with Maximal Barrier Precautions The Arrow Arterial... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2298-2017 | Class II | QuickFlash Radial Artery/Arterial Line Catheterization Kit The Arrow Arterial... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2297-2017 | Class II | Radial Artery Catheterization Kit with Sharps Safety Features The Arrow Arterial... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2296-2017 | Class II | Radial Artery Catheterization Kit with Sharps Safety Features The Arrow Arterial... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2295-2017 | Class II | Femoral Arterial Line Catheterization Kit The Arrow Arterial Catheterization device... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2294-2017 | Class II | Femoral Arterial Line Catheterization Kit The Arrow Arterial Catheterization device... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2293-2017 | Class II | Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2292-2017 | Class II | "Pressure Injectable Jugular Axillo-Subclavian Central Catheter (JACC) Product" The CG+... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2291-2017 | Class II | Arrow PICC with Chlorag+ard Technology A PICC permits venous access to the central... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2290-2017 | Class II | Arrow Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2289-2017 | Class II | Arrow Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2288-2017 | Class II | Arrow(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2287-2017 | Class II | Arrow Access Kit with Maximal Barrier Precautions for use with 4 Fr. Peripherally... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2286-2017 | Class II | Arrow PICC with Chlorag+ard Technology The ArrowEVOLUTION Pressure Injectable PICC with... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2285-2017 | Class II | Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2284-2017 | Class II | Arrow(R) VPS(R) Access Kit for use with 5 Fr. Peripherally Inserted Central Venous... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2283-2017 | Class II | Arrow VPS Access Kit with Maximal Barrier Precautions for use with 4 Fr. Peripherally... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2282-2017 | Class II | Arrow VPS Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2281-2017 | Class II | Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2280-2017 | Class II | Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2279-2017 | Class II | AGB+ Pressure Injectable Multi-Lumen CVC Kit The Arrow Central Venous Catheters are... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2278-2017 | Class II | AGB+ Pressure Injectable Multi-Lumen CVC Kit intended to permit venous access to the... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ |