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-1942-2011 | Receiver Sensor Cables, Part Numbers: 1001989, 1001990, 1004069, 1007907-NAV, GE... | GE Healthcare | LLZ | ||
| Z-1941-2011 | Transmitter Sensor Cables, Part Numbers: 1002008, 1004587, 1007914-NAV, GE Healthcare... | GE Healthcare | LLZ | ||
| Z-2211-2011 | DePuy Mitek GRYPHON P BR Anchor w/ORTHOCORD Product Code: 210814 Gryphon BR Suture... | DePuy Mitek, Inc. | MBI | ||
| Z-2210-2011 | DePuy Mitek GRYPHON P BR DS Anchor w/ORTHOCORD Product Code: 210813 Gryphon BR Suture... | DePuy Mitek, Inc. | MBI | ||
| Z-2209-2011 | DePuy Mitek GRYPHON T BR Anchor w/ORTHOCORD Product Code: 210812 Gryphon BR Suture... | DePuy Mitek, Inc. | MBI | ||
| Z-2208-2011 | DePuy Mitek GRYPHON T BR DS Anchor w/ORTHOCORD Product Code: 210811 Gryphon BR Suture... | DePuy Mitek, Inc. | MBI | ||
| Z-1492-2011 | ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511089001. An... | Disetronic Medical Systems | FRN | ||
| Z-1491-2011 | ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510937001. AC FLEXLINK... | Disetronic Medical Systems | FRN | ||
| Z-1490-2011 | ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510953001. AC FLEXLINK... | Disetronic Medical Systems | FRN | ||
| Z-1489-2011 | ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510945001. AC FLEXLINK... | Disetronic Medical Systems | FRN | ||
| Z-1488-2011 | ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510996001. AC FLEXLINK... | Disetronic Medical Systems | FRN | ||
| Z-1487-2011 | ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511020001. AC FLEXLINK... | Disetronic Medical Systems | FRN | ||
| Z-1486-2011 | ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511003001. AC FLEXLINK... | Disetronic Medical Systems | FRN | ||
| Z-1485-2011 | ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510961001. AC FLEXLINK... | Disetronic Medical Systems | FRN | ||
| Z-1484-2011 | ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510988001. AC FLEXLINK... | Disetronic Medical Systems | FRN | ||
| Z-1483-2011 | ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510970001. AC FLEXLINK... | Disetronic Medical Systems | FRN | ||
| Z-1482-2011 | ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511038001. AC FLEXLINK... | Disetronic Medical Systems | FRN | ||
| Z-1481-2011 | ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511054001. AC FLEXLINK... | Disetronic Medical Systems | FRN | ||
| Z-1480-2011 | ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511046001. AC FLEXLINK... | Disetronic Medical Systems | FRN | ||
| Z-1897-2011 | Rusch Irrigation Tray w/Bulb Catalogue Number 68895 For irrigation according to... | Teleflex Medical | KMJ | ||
| Z-1896-2011 | Rusch Irrigation Tray w/Piston Catalogue Number 67890 For irrigation according to... | Teleflex Medical | KMJ | ||
| Z-1933-2011 | Rolko Adjustable (retractable) Strap and Handle, type TGN-R100GR; a component of a... | Arjo, Inc. | FNK | ||
| Z-1979-2011 | COULTER AC-T 5diff Autoloader Hematology Analyzer, Part Number: 175356... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-1666-2011 | Labeling on box reads: MAQUET BEQ-HG 0284 3/8" X 3/8" Connectors, Lot 70041098 but the... | Maquet Cardiovascular LLC | DWE | ||
| Z-1882-2011 | iSite PACS with iSite ViewForum Applications, R7.4V6 L1 L2, L3, Versions: 3.6.96... | Philips North America LLC | LLC | ||
| Z-1881-2011 | iSite PACS with Advanced Visualization Tools (AVT) R7.4V6L1, Versions: 3.6.87, 3.6.92... | Philips North America LLC | LLC | ||
| Z-2198-2011 | Curad Flex-Fabric/Tissu Souple, 3/4 x 3 in., 100 sterile adhesive bandages, Made in... | Changzhou Hualian Health Dressing Co.,Ltd. | KGX | ||
| Z-2194-2011 | Integra NeuroSciences, Combo Kit, Lot 171237, Integra LifeSciences 3498 West 2400 South... | Integra LifeSciences Corporation | HBG | ||
| Z-2171-2011 | Ventricular Bolt Monitoring Kit W/Cranial Access, Drain, 1104HMC, Integra LifeSciences... | Integra LifeSciences Corporation | HBG | ||
| Z-1747-2011 | Organogenesis Apligraf - Interactive burn and wound dressing, supplied as a living... | Organogenesis, Inc. | MGR | ||
| Z-1700-2011 | Recall of Alcohol Pads contained in the following kits distributed by Medtronic... | Medtronic Xomed, Inc. | EPP | ||
| Z-1699-2011 | An external nasal splint is a rigid or partially rigid device intended for the use... | Medtronic Xomed, Inc. | EPP | ||
| Z-1875-2011 | CVS Pharmacy Plastic Sesame Street Adhesive Bandages; a sterile, latex free, assorted... | Pharmaplast S.A.E. | KGX | ||
| Z-1557-2011 | AquaRefresh, Multi-Purpose Solution, 2 fl.oz/60mL, Made in the Netherlands, Distributed... | Orion Vision | LPN | ||
| Z-1565-2011 | VersaCare P500 Microclimate Management Surface Upgrade Kits P3218A and P3219A Hill-rom... | Hill-Rom Inc. | FNL | ||
| Z-1564-2011 | VersaCare beds P3200 and P3201 with P500 Microclimate Management Surface Hill Rom... | Hill-Rom Inc. | FNL | ||
| Z-1563-2011 | TotalCare beds P1900 with P500 Microclimate Management Surface Hill Rom, Batesville, IN... | Hill-Rom Inc. | FNL | ||
| Z-2402-2011 | Cholestech LDX Lipid Profile"GLU test cassettes, Catalog Number 10-991, Lot #... | Alere San Diego, Inc. | CGA | ||
| Z-2182-2011 | KCI RotoProne Critical Care Therapy System buckles for securing patient to the surface... | KCI USA, Inc. | IKZ | ||
| Z-1905-2011 | ARIA versions 8.0 and 8.1 Varian Medical Systems, Palo Alto, CA 94304 The ARIA Radiation... | Varian Medical Systems, Inc. | IYE | ||
| Z-1886-2011 | Harmony LA/LED Monitor Arm Adapter. Model Number: LB61 The Harmony LA/LED Monitor Arm... | STERIS Corporation | FSY | ||
| Z-1852-2011 | Large Port Specimen Sock, used to convert the pour/accessory port of a Cardinal Suction... | Medtronic, Inc. | NNI | ||
| Z-1959-2011 | Axiom Aristos FX and FX Plus System Intended use: Stationary x-ray system | Siemens Medical Solutions USA, Inc. | KPR | ||
| Z-1561-2011 | Pulmonary Hemi-Artery SG Used in heart surgery | Artivion, Inc. | DXZ | ||
| Z-1560-2011 | Pulmonary Valve & Conduit SG Used in heart surgery | Artivion, Inc. | DXZ | ||
| Z-1013-2012 | CI healthcare***Model: CI8092***S/N: 5-60-85-044 MFD: JUN, 2010 MADE IN... | Cardiopulmonary Instrumentation | FPO | ||
| Z-1928-2011 | Hamilton-G5 Ventilator with software version V2.00x and Neonatal Option or V2.01x and... | Hamilton Medical AG | CBK | ||
| Z-1622-2011 | Fresenius Optiflux F250NRe Hemodialyzer, Single Use, Catalog Number: 0500325E, Advanced... | Fresenius Medical Care Renal Therapies Group, LLC | KDI | ||
| Z-1839-2011 | 10 ft. Interface Cable, 10 Pin - Shielded Tip Pins to 12 Pin - Blue, Manufacturing Part... | Biosense Webster Inc | DQK | ||
| Z-1844-2011 | Ellex Solo LT5106-S ophthalmic laser (not sold in USA) | Ellex Medical Pty Ltd | HQF |