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-0631-2007 | Vaxcel Implantable Vascular Access System - Titanium Mini-Port with PASV Valve and 8F... | Boston Scientific Corporation | LJT | ||
| Z-0630-2007 | Vaxcel Implantable Vascular Access System - Titanium Mini-Port with PASV Valve and 8F... | Boston Scientific Corporation | LJT | ||
| Z-0247-2007 | Dade Behring brand MicroScan Prompt Inoculation System-D; Catalog # B1026-10D; | Siemens Healthcare Diagnostics Inc. | LIE | ||
| Z-0151-2007 | VITROS Chemistry Products GLU DT Slides GEN 56, REF (Catalog #) 153 2316, 25 slides per... | Ortho-Clinical Diagnostics, Inc. | CGA | ||
| Z-0062-2007 | Cardinal Health Sterile Presource PBDS Modules, have Presource Custom Sterile Packs... | Medtronic, Inc. | LRO | ||
| Z-0061-2007 | Cardiovascular Split Sheet II, Bulk Non-Sterile; 130 units per box; Cardinal Health... | Medtronic, Inc. | KKX | ||
| Z-0060-2007 | Presource Custom Sterile Packs containing the Cardiovascular Split Drape II; the custom... | Medtronic, Inc. | LRO | ||
| Z-0067-2007 | Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the... | Abbott Medical | MMP | ||
| Z-0066-2007 | Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the... | Abbott Medical | MMP | ||
| Z-0065-2007 | Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the... | Abbott Medical | MMP | ||
| Z-0064-2007 | Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the... | Abbott Medical | MMP | ||
| Z-0129-2007 | Sheridan T.T.X. Tracheal Tube Exchanger, Large Size for tracheal tube sizes 7.5 mm - 10.0... | Teleflex Medical | LNZ | ||
| Z-0128-2007 | Sheridan Preformed Cuffed Nasal Tracheal Tube, 7.5 mm; a Rx, sterile, single use tracheal... | Teleflex Medical | BTR | ||
| Z-0127-2007 | Sheridan Preformed Cuffed Oral Tracheal Tube, 5.0 mm; a Rx, sterile, single use tracheal... | Teleflex Medical | BTR | ||
| Z-0126-2007 | Sheridan Preformed Uncuffed Oral Tracheal Tube, 3.0 mm; a Rx, sterile, single use... | Teleflex Medical | BTR | ||
| Z-0125-2007 | Sheridan Sher-I-Bronch Endobronchial Tube, Left-Sided, 37 Fr, 26 mm tracheal cuff, 19 mm... | Teleflex Medical | BTS | ||
| Z-0059-2007 | Convertors Cardiovascular Split Pack II, the pack contains 1 Tiburon Cardiovascular Split... | Medtronic, Inc. | LRO | ||
| Z-0058-2007 | Convertors Tiburon Cardiovascular Split Drape II, Sterile, for single use only; Cardinal... | Medtronic, Inc. | KKX | ||
| Z-0063-2007 | AC-powered Adjustable Hospital Bed. (ICCG Bed) Affected Model numbers: IH820-3MDLX... | Invacare GmbH | LLI | ||
| Z-1166-2007 | Orbit 90 Subcutaneous Infusion Set, 9 mm Catheter, 42" Tubing - Blue, List #P4291 | Abbott Medical | FPA | ||
| Z-0454-2007 | Phenobarbital- Reagent-Clinical Chemistry--List number: 1E08-20-Abbott Diagnostics... | Abbott Medical | DLZ | ||
| Z-1621-2011 | i-STAT G3+ Cartridge: PCO2 Abbott Point of Care, Princeton, NJ 08540 The test for PCO2... | Abbott Medical | CHL | ||
| Z-0398-2007 | Product is Mucotrol Concentrated Oral Gel Wafer contained in HDPE Bottle. | Belcher Pharmaceuticals, Inc. | FRO | ||
| Z-0579-2009 | Triathlon Total Knee system Primary Tibial Baseplate #5 Beaded wPA; Catalog Number... | Howmedica Osteonics Corp | MBH | ||
| Z-0299-2007 | Advanced Bionics Precision Linear Leads, part of the Precision Spinal Cord Stimulation... | Advanced Bionics LLC | LGW | ||
| Z-0304-2007 | 4D Integrated Treatment Console and Varis 1.4g Medical Charged Particle Radiation Therapy... | Varian Medical Systems, Inc. | IYE | ||
| Z-0184-2007 | M1020B PulseOximetry Module Philips FAST Sp02 and Pulse Oximetry Nellcor OxiMax... | Philips North America LLC | DQA | ||
| Z-0183-2007 | M3001A Philips Multi Measurement Server (MMS) | Philips North America LLC | DQA | ||
| Z-0081-2007 | Boston Scientific 10 Fr (3.3 mm) Flexima Regular APDL All Purpose Drainage catheter set... | Boston Scientific Corporation | FFA | ||
| Z-0080-2007 | Cook Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent... | Cook Incorporated | FGE | ||
| Z-0744-2007 | Mega Diagnostics Alcohol Standard (Cat.# A7504-STD) packaged in 5ml vials. | Mega Diagnostics | JIX | ||
| Z-0743-2007 | Mega Diagnostics Ammonia/Alcohol Controls (Cat.# A7504-CTL) packaged in 5ml vials | Mega Diagnostics | JIX | ||
| Z-0451-2007 | Drew Excell 22 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX. | JAS Diagnostics/Drew Scientific | GKZ | ||
| Z-0450-2007 | Bayer Advia 70 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX. | JAS Diagnostics/Drew Scientific | GKZ | ||
| Z-0164-2007 | 3.0T HD Head Neck Spine Array, Model 2415545, for GE 3.0T Excite MR System. | GE Healthcare Coils | MOS | ||
| Z-0163-2007 | 1.5T HD Head Neck Spine Array, Model 2416329, for GE 1.5T Excite MR System. | GE Healthcare Coils | MOS | ||
| Z-0450-2008 | Triathlon MIS Modular Capture;Catalog Number: 6541-5-723; Stryker Orthopaedics, Mahwah... | Howmedica Osteonics Corp | JWH | ||
| Z-0449-2008 | Triathlon MIS Femoral Adjustment Block;Catalog Number: 6541-5-601;Stryker Orthopaedics... | Howmedica Osteonics Corp | JWH | ||
| Z-0448-2008 | Triathlon MIS AP Sizer Body - Left and Right; Catalog Number: 6541-5-508- left; Catalog... | Howmedica Osteonics Corp | JWH | ||
| Z-0246-2007 | Abbott brand CELL-DYN 22 Calibrator, a whole blood calibrator used to calibrate CELL-DYN... | Abbott Medical | KRY | ||
| Z-0076-2007 | Stanbio Laboratory SIRRUS Direct HDL Cholesterol LiquiColor, Catalog #S0590-540; kit... | Stanbio Laboratory | LBR | ||
| Z-0075-2007 | Stanbio Laboratory Direct HDL Cholesterol LiquiColor, Catalog #0590-080; test kit... | Stanbio Laboratory | LBR | ||
| Z-0074-2007 | Stanbio Laboratory Direct HDL Cholesterol LiquiColor, Catalog #0590-040; test kit... | Stanbio Laboratory | LBR | ||
| Z-0348-2007 | Lens Plus Ocupure Saline Sterile Rinsing Solution (Asia Pacific markets, excluding Japan)... | Advanced Medical Optics, Inc. | LPN | ||
| Z-0347-2007 | Complete Blink N Clean (US and Asia Pacific markets) | Advanced Medical Optics, Inc. | LPN | ||
| Z-0346-2007 | COMPLETE Multi-Purpose Solution (Asia Pacific markets, excluding Japan, Korea and... | Advanced Medical Optics, Inc. | LPN | ||
| Z-0345-2007 | Krystal Klear Rinse (China only) | Advanced Medical Optics, Inc. | LPN | ||
| Z-0316-2007 | Posterior Acetabular Retractor-Left with Light Cord Bracket, Model #BIO-1-1050-A, and... | Whiteside Biomechanics, Inc. | GAD | ||
| Z-0344-2007 | COMPLETE MoisturePLUS Multi-Purpose Solution (US and Asia Pacific markets, excluding... | Advanced Medical Optics, Inc. | LPN | ||
| Z-0201-2007 | Datex-Ohmeda Tec 6 Plus Desflurane Vaporizer. It is an electronic vaporizer which... | GE Healthcare | CAD |