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-0621-2008 | Stryker Orthopaedics, UHR Universal Bipolar Component; 26 x 42 mm, Hip Prosthesis... | Howmedica Osteonics Corp | KWL | ||
| Z-0129-2008 | Welch Allyn AED 10, Automated External Defibrillator, a portable 12V internal battery... | Welch Allyn Protocol, Inc. | MKJ | ||
| Z-0568-2008 | Cyberonics, VNS Therapy System Model 250 Handheld programming system using Dell x5... | LivaNova USA, Inc. | LYJ | ||
| Z-0551-2008 | Abbott, ACCELERATOR Device Manager (ADM); List Number: 08H74-01; Abbott Laboratories... | Abbott Medical | JQP | ||
| Z-0292-2008 | Medrad Avanta Multi-Patient Disposable Hand Controller, Angiographic Injector and... | Medrad, Inc. | DXT | ||
| Z-0263-2008 | Baxter Duploject Easy Prep, Fibrin Sealant Preparation and Application System ISO... | Baxter Healthcare Corporation | FMF | ||
| Z-1625-2008 | Remel RapID Inoculation Fluid, Microorganism differentiation and identification device... | Remel Inc | LIB | ||
| Z-1716-2008 | Generation 4 electronic liquid gauges used on the Caire Liberator, Stroller, Sprint, and... | Caire, Inc. | BYJ | ||
| Z-1624-2008 | Remel RapID Inoculation Fluid, Microorganism differentiation and identification device... | Remel Inc | LIB | ||
| Z-0825-2008 | OsteoStim Cervical Allograft (Lordotic Cervical Spacer) H. 7mm; W. 14mm; L. 10mm... | Ebi, LLC | MQV | ||
| Z-2238-2009 | SYNCHRON Systems Salicylate (SALY) Reagent; Part Number: 378194. SALY reagent, when... | Siemens Healthcare Diagnostics Inc. | DKJ | ||
| Z-1517-2008 | GE Healthcare Innova 4100 Digital Fluoroscopic Imaging System with Bolus Chasing option. | GE Healthcare | MQB | ||
| Z-1516-2008 | GE Healthcare Innova 3100 Digital Fluoroscopic Imaging System with Bolus Chasing option. | GE Healthcare | MQB | ||
| Z-0212-2008 | Thoratec Implantable Ventricular Assist Device (IVAD pump) (Component of Thoratec... | Abbott Medical | DSQ | ||
| Z-0529-2008 | Oxy Serve II Oxygen Conserving Regulator, Model Number: MCRB-870-6, Superior Products... | Superior Products, LLC | NFB | ||
| Z-0620-2008 | Zimmer Trilogy Acetabular System Shell with Cluster Holes, Porous, 60mm O.D., Tivanium... | Zimmer GmbH | LPH | ||
| Z-2221-2012 | Class II | GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City... | GE Healthcare | JAA | |
| Z-0705-2008 | Biomet RINGLOC + Instrumentation Impactor Plate, Size 28; REF/Part#: 31-400628, Biomet... | Zimmer GmbH | LXH | ||
| Z-0704-2008 | Biomet RINGLOC + Instrumentation Impactor Plate, Size 26; REF/Part#: 31-400626, Biomet... | Zimmer GmbH | LXH | ||
| Z-0703-2008 | Biomet RINGLOC + Instrumentation Impactor Plate, Size 23; REF/Part#: 31-400623, Biomet... | Zimmer GmbH | LXH | ||
| Z-0702-2008 | Biomet RINGLOC + Instrumentation Impactor Plate, Size 22; REF/Part#: 31-400622, Biomet... | Zimmer GmbH | LXH | ||
| Z-0701-2008 | Biomet RINGLOC + Instrumentation Impactor Plate, Size 21; REF 31-400621,Biomet... | Zimmer GmbH | LXH | ||
| Z-0700-2008 | Biomet RINGLOC + Instrumentation Impactor Plate, Size 20; REF/Part #: 31-400620, Biomet... | Zimmer GmbH | LXH | ||
| Z-0458-2008 | Hypoguard Advance Micro-draw Blood Glucose Monitoring System, Product Number : 411100... | Arkray Factory USA, Inc. | CGA | ||
| Z-0183-2008 | GE OEC, Insta Trak 3500 Plus with the Cranial Application for Image Guided Surgery, GE... | GE Healthcare | LLZ | ||
| Z-0375-2008 | Abbott Point of Care, i-STAT G Cartridge; (Glucose/Glu); List No: 06F09-01; Part No... | Abbott Medical | JGS | ||
| Z-0374-2008 | Abbott Point of Care, i-STAT EC8+ Cartridge; (NA K CL Glu pH PCO 2 UN/Urea Hct); List No... | Abbott Medical | JGS | ||
| Z-0373-2008 | Abbott Point of Care, i-STAT CREA Cartridge (Creatine/Crea); List No: 06F10-01; Part No... | Abbott Medical | JGS | ||
| Z-0372-2008 | Abbott Point of Care, i-STAT EC4+ Cartridge; (NA K Glu Hct); List No: 06F07-01; Part No... | Abbott Medical | JGS | ||
| Z-0371-2008 | Abbott Point of Care, i-STAT E3+ Cartridge, (NA K Hct); List No: 06F08-01; Part No... | Abbott Medical | JGS | ||
| Z-0370-2008 | Abbott Point of Care, i-STAT 6+ Cartridge (Na K CL BUN/Urea GLU Hct); List No: 06F05-01... | Abbott Medical | JGS | ||
| Z-1475-2008 | Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin... | Siemens Healthcare Diagnostics Inc. | JHI | ||
| Z-1299-2008 | AlloCraft DBM with Syringe Assembly, 10 CC, LifeCell Corporation, Branchburg, NJ 08876... | LifeCell Corp | MQV | ||
| Z-1298-2008 | AlloCraft DBM with Syringe Assembly, 5CC, Catalog/Reorder Number: 653005, LifeCell... | LifeCell Corp | MQV | ||
| Z-1183-2008 | Access Power Supply Assembly Sled Part Number: A48196/6845C; Component of: Access and... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-0569-2008 | 3M ESPE Unitek Stainless Steel Permanent Molar Crowns , Product Code: 900321, Made in... | 3M Company | ELZ | ||
| Z-0294-2008 | Medtronic 0-arm Imaging System, Product Catalog Number: B1-700-00027, Medtronic... | Medtronic Navigation, Inc | JZL | ||
| Z-1093-2008 | Lead Wire Pin/Socket 24 in 1 pr model number 9520. Filter, mask, and/or accessories for... | Respironics, Inc. | FLS | ||
| Z-1092-2008 | Oximetry Ear Clip Sensor model number 948. Filter, mask, and/or accessories for sleep... | Respironics, Inc. | DOA | ||
| Z-1091-2008 | Oximeter Patient Cable Masimo 8 ft model number H5870. Filter, mask, and/or accessories... | Respironics, Inc. | NPF | ||
| Z-1090-2008 | ECG Lead Set 60 in SOC to Snap model number 8049-1. Filter, mask, and/or accessories... | Respironics, Inc. | GWO | ||
| Z-1089-2008 | Stardust Flexible Y Sensor Probe model number 612054. Filter, mask, and/or accessories... | Respironics, Inc. | MNR | ||
| Z-1088-2008 | Non-continuous ventilators under the following brand names: a) Sync S/T Lab, w/o modem... | Respironics, Inc. | MNS | ||
| Z-1087-2008 | Breathing Frequency Monitor Stardust 2 Domestic model number 1025720. Filter, mask... | Respironics, Inc. | MNR | ||
| Z-1086-2008 | APNEA monitor accessories under the following brand names: a) SM 2 PS/PSL, Prof... | Respironics, Inc. | NPF | ||
| Z-1085-2008 | Continuous ventilator accessories under the following brand names: a) RP-Seal, Spring-5... | Respironics, Inc. | CBK | ||
| Z-1084-2008 | RP-REMStar Plus Keypad model number 1006852. Filter, mask, and/or accessories for sleep... | Respironics, Inc. | BZD | ||
| Z-1083-2008 | RP-REM Auto w/C-FLEX/REM Pro Tubing Kit model number 1008492 and RP-REM Power Cord N... | Respironics, Inc. | BZD | ||
| Z-1082-2008 | RP-Leaf, Check valve-5 pk model number F33440. Filter, mask, and/or accessories for... | Respironics, Inc. | CBK | ||
| Z-1081-2008 | RP Duet LX/Pro Out Port w/Seal model number 622239. Filter, mask, and/or accessories... | Respironics, Inc. | BZD |