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-1073-2007 | Gyrus CyberWand Ultrasonic Lithotripter System includes: CW-USLS CyberWand USL System... | Gyrus ACMI, Inc. | FFK | ||
| Z-0885-2007 | Terumo TenderFlow Pediatric Arterial Cannulae, 5.3mm (16 Fr) OD, with 1/4 inch... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-0884-2007 | Terumo TenderFlow Pediatric Arterial Cannulae, 5.3 mm (16 Fr) OD, with 1/4 inch vented... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-0883-2007 | Terumo TenderFlow Pediatric Arterial Cannulae, 4.7mm (14 Fr) OD, with 1/4 inch... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-0882-2007 | Terumo TenderFlow Pediatric Arterial Cannulae, 4.7 mm (14Fr) OD, with 1/4 inch vented... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-0881-2007 | Terumo TenderFlow Pediatric Arterial Cannulae, 4.0mm (12 Fr) OD, with 1/4 inch... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-0880-2007 | Terumo TenderFlow Pediatric Arterial Cannulae, 4.0 mm (12 FR) OD, with 1/4 inch vented... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-0879-2007 | Terumo TenderFlow Pediatric Arterial Cannulae, 3.3mm (10 Fr) OD, with 1/4 inch... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-0878-2007 | Terumo TenderFlow Pediatric Arterial Cannulae, 3.3 mm (10Fr) OD, with 1/4 inch vented... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-0877-2007 | Terumo TenderFlow Pediatric Arterial Cannulae, 2.7mm (8Fr) OD, with 1/4 inch non-vented... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-0876-2007 | Terumo TenderFlow Pediatric Arterial Cannulae, 2.7mm (8 Fr) OD, with 1/4 inch vented... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-0875-2007 | Terumo TenderFlow Pediatric Arterial Cannulae, 2.0mm (6Fr) OD, with 1/4 inch non-vented... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-0874-2007 | Terumo TenderFlow Pediatric Arterial Cannulae, 2.0 mm (6Fr) OD, with 1/4 inch vented... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-0525-2008 | Beckman Coulter Flow-Count Fluorospheres - Part Number 7547053, Beckman Coulter, Inc... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-1115-2007 | ThromCat Thrombectomy Catheter System. Catalog number 63000-01 | DSM Biomedical, Inc. | MCW | ||
| Z-1107-2007 | Amplilink Software Versions 1.1, 1.3, 1.4, 2.41 COBAS AmpliPrep/COBAS Amplicor HCV Test... | Roche Molecular Systems Inc | MZP | ||
| Z-1106-2007 | Amplilink Software versions 1.1, 1.3, 1.4, 2.41. COBAS Amplicor CTA & NGA Tests | Roche Molecular Systems Inc | JJF | ||
| Z-1188-2008 | Reusable Ohmeda Compatible Finger Clip Sensor, Model Number: E403-02, Product Code... | Kentec Medical, LLC | DQA | ||
| Z-1130-2007 | Cleaning probe included as an accessory to aspirators that are sterile packed single use... | GE Healthcare | LLZ | ||
| Z-0992-2007 | Amplatz Goose Neck Snare Kit, 6 Fr, Lot 1650307, REF: GN3000, Use By 2009-09-01, Sterile... | Medtronic, Inc. | DXE | ||
| Z-1008-2007 | Anspach Single Use, Sterile Bone Cutting Burrs | The Anspach Effort, Inc. | HBB | ||
| Z-1750-2008 | Omnifit EON Surgical Protocol; Literature Number: LSP48 4/04 Stryker Howmedica Osteonics... | Howmedica Osteonics Corp | LXH | ||
| Z-0262-2008 | Edwards Vigilance II Continuous Cardiac Output/Oximetry/Volumetric (CCO/SvO2/CEDV)... | Edwards Lifesciences LLC | DXG | ||
| Z-1167-2007 | VITROS 5,1 FS (Fusion Series) Chemistry System Software Version 2.2.1, only when using... | Ortho-Clinical Diagnostics, Inc. | JJE | ||
| Z-0957-2007 | BD Microtainer Tube with Glycolytic Inhibitor, Catalog Number 365992, Non Sterile, 200 (4... | Becton Dickinson & Co | |||
| Z-1171-2007 | Cell-Dyn 1700CS (Closed Sampler) Hematology Analyzer, List Numbers 03H57-01 and 03H57-03... | Abbott Medical | GKZ | ||
| Z-1170-2007 | CELL-DYN 1700 Hematology Analyzer, List Numbers 03H53-01 and 03H53-03, software... | Abbott Medical | GKZ | ||
| Z-0991-2007 | Pneupac VR1 Standard and VR1 Responder is a hand held portable, time cycled, gas powered... | Abbott Medical | BTL | ||
| Z-1245-2009 | Hydration Station with Pedestal (Part # E30003-01), Hydration Station with Pedestal & DVD... | Sybaritic, Inc. | IMB | ||
| Z-0363-2008 | Ascent POCTS (Posterior Occipital Cervical Thoracic System) Part Numbers: 65-33 XX Series... | Blackstone Medical, Inc. | MNI | ||
| Z-1041-2007 | ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by... | Abbott Medical | JQP | ||
| Z-0988-2007 | MediSpectra Luma Cervical Imaging System Model Number: 3-02600 | Medispectra Inc. | MWM | ||
| Z-0977-2007 | Roche Cortisol reagent for use in conjunction with Roche cobas e 411, cobas e 601... | Roche Diagnostics GmbH | NHG | ||
| Z-1824-2008 | Headset Model Number RTC-551-070 for use with the Serene Sound Digital MRI Compatible... | Resonance Technology Inc | LNH | ||
| Z-1823-2008 | Headset Model Number RTC-2K for use with the Serene Sound Digital MRI Compatible High... | Resonance Technology Inc | LNH | ||
| Z-1244-2008 | WEB1000 Versions 3.1, 4.1 and 5.1, Picture Archiving and Communications systems (PACs)... | AGFA Healthcare Corp. | LLZ | ||
| Z-1243-2008 | IMPAX 4.1, IMPAX 4.5, IMPAX 5.0, IMPAX 5.1 IMPAX 5.2, IMPAX 6.0, IMPAX 6.2; Picture... | AGFA Healthcare Corp. | LLZ | ||
| Z-0137-2008 | Freedom Designs TriPod w/Anti tipper Manual Wheelchair, Models Numbers: TriPod, Tripod LT... | Freedom Designs Inc | IOR | ||
| Z-1245-2007 | daVinci S Surgical system, patient side cart Auxiliary power board (APB) (printed circuit... | Intuitive Surgical, Inc. | NAY | ||
| Z-0959-2007 | Biomet 3 i, Disposable Twist Drills, Model Number DT2715. | ZimVie US Corp LLC | DZE | ||
| Z-1098-2007 | ARCHITECT AUSAB Controls list number 1L82-10 have two bottles with the following... | Abbott Diagnostic International, Ltd. | LOM | ||
| Z-1097-2007 | Architect AUSAB Calibrators IVD - list number 1L82-01 has six (6) bottles with the... | Abbott Diagnostic International, Ltd. | LOM | ||
| Z-1096-2007 | ARCHITECT AUSAB Reagent list number 1L82-25 has the following components: 1) Architect... | Abbott Diagnostic International, Ltd. | LOM | ||
| Z-0956-2007 | MagNA Pure LC Total Nucleic Acid Isolation Kit - Large Volume; Catalog # 03264793001. | Roche Diagnostics GmbH | NPQ | ||
| Z-1099-2007 | Power Linear Cutter Reusable Digital Loading Units with Reloads. Common name... | Power Medical Interventions, Inc. | GDW | ||
| Z-1200-2007 | Abbott CELL-DYN 3700 Hematology Analyzer | Abbott Medical | GKZ | ||
| Z-1199-2007 | Abbott CELL-DYN 3500 Hematology Analyzer | Abbott Medical | GKZ | ||
| Z-1198-2007 | Abbott CELL-DYN 3000 Hematology Analyzer | Abbott Medical | GKZ | ||
| Z-0927-2007 | NeatNick Sweeping Action Heel Lancet - Preemie- Item Number: 1030083 (box of 100) and... | Hawaii Medical LLC | FMK | ||
| Z-0926-2007 | NeatNick Sweeping Action Heel Lancet -Full-Term- Item Number: 1030085 (box of 100) and... | Hawaii Medical LLC | FMK |