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-0352-2010 | Orthopediatrics IM Femoral Nail - 7mm x 20 cm, Lt, non-sterile, Orthopediatrics, Warsaw... | Orthopediatrics Corp | HSB | ||
| Z-0351-2010 | Orthopediatrics IM Femoral Nail - 8mm x 36 cm, Rt, non-sterile, Orthopediatrics, Warsaw... | Orthopediatrics Corp | HSB | ||
| Z-0350-2010 | Orthopediatrics IM Femoral Nail - 8mm x 34 cm, Rt, non-sterile, Orthopediatrics, Warsaw... | Orthopediatrics Corp | HSB | ||
| Z-0349-2010 | Orthopediatrics IM Femoral Nail - 8mm x 32 cm, Rt, non-sterile, Orthopediatrics, Warsaw... | Orthopediatrics Corp | HSB | ||
| Z-0348-2010 | Orthopediatrics IM Femoral Nail - 8mm x 30 cm, Rt, non-sterile, Orthopediatrics, Warsaw... | Orthopediatrics Corp | HSB | ||
| Z-0347-2010 | Orthopediatrics IM Femoral Nail - 8mm x 28 cm, Rt, non-sterile, Orthopediatrics, Warsaw... | Orthopediatrics Corp | HSB | ||
| Z-0346-2010 | Orthopediatrics IM Femoral Nail - 8mm x 26 cm, Rt, non-sterile, Orthopediatrics, Warsaw... | Orthopediatrics Corp | HSB | ||
| Z-0345-2010 | Orthopediatrics IM Femoral Nail - 8mm x 24 cm, Rt, non-sterile, Orthopediatrics, Warsaw... | Orthopediatrics Corp | HSB | ||
| Z-0344-2010 | Orthopediatrics IM Femoral Nail - 7mm x 30 cm, Rt, non-sterile, Orthopediatrics, Warsaw... | Orthopediatrics Corp | HSB | ||
| Z-0343-2010 | Orthopediatrics IM Femoral Nail - 7mm x 28 cm, non-sterile, Orthopediatrics, Warsaw, IN... | Orthopediatrics Corp | HSB | ||
| Z-0342-2010 | Orthopediatrics IM Femoral Nail - 7mm x 26 cm, Rt, non-sterile, Orthopediatrics, Warsaw... | Orthopediatrics Corp | HSB | ||
| Z-0341-2010 | Orthopediatrics IM Femoral Nail - 7mm x 24 cm, Rt, non-sterile, Orthopediatrics, Warsaw... | Orthopediatrics Corp | HSB | ||
| Z-034-2010 | Orthopediatrics IM Femoral Nail - 7mm x 22 cm, Rt, non-sterile, Orthopediatrics, Warsaw... | Orthopediatrics Corp | HSB | ||
| Z-0339-2010 | Orthopediatrics IM Femoral Nail - 7mm x 20 cm, Rt, non-sterile, Orthopediatrics, Warsaw... | Orthopediatrics Corp | HSB | ||
| Z-1996-2009 | Coloplast, InterDry Ag 10" x 144" Roll P/N 6791001400, Manufactured for Coloplast A/S... | MEDLINE INDUSTRIES, LP - Northfield | FRL | ||
| Z-2631-2017 | Class III | Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) Wide Range... | Horiba Instruments Incorporated | DCK | |
| Z-2761-2011 | Active Cortisol EIA, 96 Wells, DSL-10-2000 The DSL-10-2000 Active Cortisol Enzyme... | Siemens Healthcare Diagnostics Inc. | CGR | ||
| Z-0919-2011 | Product labeling of the X3 Display reads in part: "XSENSOR Technology Corporation***X3... | Xsensor Technology Corp. | JFC | ||
| Z-0818-2010 | Staphytect Plus, packaged in 100- and 500-test boxes, Catalog #DR0850M (100 tests) and... | Remel Inc | JWX | ||
| Z-0817-2010 | Oxoid dry Spot Staphytect Plus, Catalog #DR0100M, 120 tests/kit. Oxoid Ltd., Wade road... | Remel Inc | JWX | ||
| Z-1933-2009 | Boston Scientific TELIGEN, Implantable Cardiac Defibrillator, Models E102 and E110... | Boston Scientific Corporation | LWP | ||
| Z-1932-2009 | Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, Models... | Boston Scientific Corporation | LWP | ||
| Z-1692-2009 | Prolieve Thermodilatation Catheter Kit, a Transurethral Microwave Therapy (TUMT) System... | Boston Scientific Corporation | MEQ | ||
| Z-1992-2009 | Turon Revision Glenoid Poly Liner. The Metal Backed Revision Glenoid is a two piece... | Encore Medical, LP | MBF | ||
| Z-0259-2010 | Medtronic Integrated Power Console System, IP X1 REF 1898001 or REF EC300 Medtronic... | Medtronic Xomed, Inc. | ERL | ||
| Z-0655-2010 | Complete SE Biliary Stent System, SC680L (6 mm x 120 mm), lot number 0000983806, UPC code... | Medtronic, Inc. | FGE | ||
| Z-0654-2010 | Complete SE Biliary Stent System, SC5120L (5 mm x 12 mm), lot number 0000983799, UPC code... | Medtronic, Inc. | FGE | ||
| Z-2231-2009 | Varian Medical Systems, Eclipse Proton Convolution Superposition DCF, version 8.6.15... | Varian Medical Systems, Inc. | MUJ | ||
| Z-0064-2010 | 200996-Cable Assembly, Hybrid Extended Length, 200997 Cable Assembly, Hybrid, Guidance... | Mako Surgical Corp. | HAW | ||
| Z-1027-2011 | SEQUENCER component of MOSAIQ versions 1.30 (all builds), 1.40 (all builds), 1.50 (all... | Elekta Limited | IYE | ||
| Z-0132-2010 | ARCHITECT i2000 System and ARCHITECT i2000 SR wash buffer and wash zone mechanism... | Abbott Medical | JJE | ||
| Z-1955-2009 | Stabilet Infant Warming System, model numbers 200, 300, 1250, 1500, 200/3000, 2000... | Draeger Medical Systems, Inc. | FMT | ||
| Z-1878-2009 | Gel Filled Teethers, various shapes and sizes, marketed under the names: Nuby... | Luv N' Care Ltd | KKO | ||
| Z-0065-2010 | CELL-DYN Emerald Hematology Analyzer, model number 09H39-01. Distributed by Abbott... | Abbott Medical | GKZ | ||
| Z-1898-2009 | SmartPort CT Port Access System, Catalog number CT80STPD, AngioDynamics... | Boston Scientific Corporation | LJT | ||
| Z-1887-2009 | Agfa Impax R6.3 DB Server. Impax Systems are Picture Archiving and Communication... | AGFA Healthcare Corp. | LLZ | ||
| Z-1532-2010 | Plasma Chemical Sterilization Indicator. Product Numbers Cl 115, PL 173, PL 205. | Steritec Products Mfg. Co., Inc. | JOJ | ||
| Z-1161-2010 | da Vinci S Surgical System IS2000 Endoscopic Instrument Control System, rev. A51_P7... | Intuitive Surgical, Inc. | NAY | ||
| Z-1531-2010 | Violet Ink sterilization indicators Violet Ink (Class 6) and Violet Ink (Bowie Dick)... | Steritec Products Mfg. Co., Inc. | JOJ | ||
| Z-2050-2009 | Portex Continuous Epidural Tray, Reference 4037-20 An anesthesia conduction kit is a... | Abbott Medical | BSO | ||
| Z-0973-2011 | RF Ablation System Foot Switch, used with the EPT-1000 RF Generator, Foot Switch Model... | Boston Scientific Corporation | LPB | ||
| Z-1145-2010 | BIO-RAD 425-2020 Autoimmune EIA Anti-Cardiolipin IgM, 96 Tests...2010 02 16...Lot CL-863... | Bio-Rad Laboratories Inc. | DHC | ||
| Z-1991-2009 | EasyLink Informatics System included with the Dimension Vista System. The Dimension... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-2282-2012 | Class II | Whole Body X--ray Scanner This device is indicated as a whole body volume CT system. The... | Canon Medical Systems USA, Inc. | JAK | |
| Z-2108-2009 | Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS185-01, Integra... | Integra Pain Management | CAZ | ||
| Z-2107-2009 | Complete Single Shot Tray, Disposable, Convenience Kit, Reorder Number CUS042, Integra... | Integra Pain Management | CAZ | ||
| Z-2106-2009 | Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number SS1719, Integra... | Integra Pain Management | CAZ | ||
| Z-2105-2009 | Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS1593-01... | Integra Pain Management | CAZ | ||
| Z-2104-2009 | Universal Block Tray, Disposable, Convenience Kit, Reorder Number CUS1756, Integra... | Integra Pain Management | CAZ | ||
| Z-2103-2009 | Universal Block Tray, Disposable, Convenience Kit, Reorder Number CUS1619, Integra... | Integra Pain Management | CAZ |