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-0149-2010 | Stryker Medical Stair-PRO Stair Chair with wheels and a track system, patient transport... | Stryker Medical | FPP | ||
| Z-0148-2010 | Stryker Medical Stair-PRO Stair Chair with wheels, patient transport device, Model 6251. | Stryker Medical | FPP | ||
| Z-2024-2010 | Angiotech Needle Guide. Needle Guide for Lorad Stereo Loc. STERILE. Product Number... | Medical Device Technologies, Inc. | GDF | ||
| Z-2023-2010 | Angiotech Drainage Cather. SKATER Centesis Cather XFr. STERILE. Product Number... | Medical Device Technologies, Inc. | JCY | ||
| Z-2022-2010 | Angiotech Prostate Stabilization Set. Prostate Stabilization Set. STERILE. Product... | Medical Device Technologies, Inc. | IWJ | ||
| Z-2021-2010 | Angiotech Access Needle. A) Hawkins Blunt Needle. STERILE. Product Number: 216057... | Medical Device Technologies, Inc. | KNW | ||
| Z-2020-2010 | Angiotech Galactography Kit. Galactography Kit 30ga with Straight Cannula and... | Medical Device Technologies, Inc. | FMI | ||
| Z-2019-2010 | Angiotech Pediatric Bone Marrow Needle. Pediatric Bone Marrow Needle. STERILE. Product... | Medical Device Technologies, Inc. | KNW | ||
| Z-2018-2010 | Angiotech Vascular Access Needle. A) "Modified Potts/Cournand" Needle. STERILE... | Medical Device Technologies, Inc. | DRC | ||
| Z-2017-2010 | Angiotech Breast Localization Needles: A) Accura BLN and Accura II BLN with Stiffening... | Medical Device Technologies, Inc. | GAA | ||
| Z-2016-2010 | Angiotech Soft Tissue Biopsy Needle Core: A) Pro-Mag "Short Throw" Biopsy Needle, and... | Medical Device Technologies, Inc. | KNW | ||
| Z-2015-2010 | Angiotech Breast Localization Needles: A) Accura BLN and Accura II BLN with Stiffening... | Medical Device Technologies, Inc. | GDM | ||
| Z-1534-2010 | Hitachi Oasis Magnetic Resonance Scanners Software V1.0C The intended use: The MR system... | FUJIFILM Healthcare Americas Corporation | IWE | ||
| Z-0581-2010 | Enpath Myopore Sutureless Myocardial Pacing Lead, Ref: 511211. the contents of the... | Greatbatch Medical | DTB | ||
| Z-0580-2010 | Enpath Lead Adapter, Ref: 501214. The contents of the inner package have been sterilized... | Greatbatch Medical | DTB | ||
| Z-2334-2010 | Triathlon Total Knee System Primary Tibial Baseplate; Sterile, Made in... | Howmedica Osteonics Corp | JWH | ||
| Z-1205-2010 | Dimension Vista System StreamLAB Analytical Workcell. Dimension Vista System Part Numbers... | Siemens Healthcare Diagnostics Inc. | CDT | ||
| Z-0508-2010 | Secur-Fit MAX Secure-FIT Plus Max Surgical Protocol. Surgical protocols instruct... | Howmedica Osteonics Corp | LZO | ||
| Z-0507-2010 | OnmiFit HFx Surgical Protocol 127 degree and 132 degree Surgical Protocol; Stryker, 325... | Howmedica Osteonics Corp | LZO | ||
| Z-0506-2010 | OmniFit Eon 127 degree and 132 degree Surgical Protocol; Stryker. Surgical protocols... | Howmedica Osteonics Corp | LZO | ||
| Z-0505-2010 | CuttingEdge Total Hip Instrumentation Surgical Protocol; Acetabular and Femoral Surgical... | Howmedica Osteonics Corp | LZO | ||
| Z-0504-2010 | Accolade System Surgical Technique; Accolade C - Cemented Hip Stem; Accolade TMZF... | Howmedica Osteonics Corp | LZO | ||
| Z-0864-2010 | Dimension Vista System CHEM 1 CAL, Catalog Number KC110, Lot Number 9DM001 The... | Siemens Healthcare Diagnostics Inc. | JIX | ||
| Z-0134-2010 | Stryker Imaging, Guardian Services Software, Part Number 0240-009-430 with Part Numbers... | Stryker Imaging | LMB | ||
| Z-2315-2009 | ZOLL R Series Defibrillator/Pacemaker/Monitor Used by qualified medical personnel for... | ZOLL Medical Corporation | MKJ | ||
| Z-0124-2010 | CIVCO MTAPSID2932 Type-S Thermoplastic, Disposable nonsterile (48.3 cm) IMRT Style 29... | Medtec LLC | IYE | ||
| Z-0179-2010 | System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA... | Baxter Healthcare Renal Div | KDI | ||
| Z-0477-2011 | GE Healthcare IDI Mammo Workstation | GE Healthcare | LLZ | ||
| Z-0476-2011 | GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 | GE Healthcare | LLZ | ||
| Z-0360-2011 | SoftID.NET versions 2.0.0.6 - 2.0.0.19. SCC Soft Computer 5400 Tech Data Drive... | SCC Soft Computer | LNX | ||
| Z-1392-2011 | V5M TEE Transducer, when used with an ACUSON S2000 ultrasound system that has cardiac... | Siemens Medical Solutions USA, Inc. | ITX | ||
| Z-0125-2010 | ClearSight(TM) 1-Day (ocufilcon D) Toric 30 daily disposable contact lenses for... | CooperVision, Inc. | MVN | ||
| Z-0069-2010 | Extended PTFE Coated Blade electrosurgical electrodes, 6.5" (16.51CM) Length, 12 each &... | Unimed Surgical Products, Inc. | GEI | ||
| Z-0141-2010 | Cardinal Health, Craig Calibrated Cannula, overall length 5-3/8" (13.7 cm), catalog... | Medtronic, Inc. | FCG | ||
| Z-2076-2009 | Medtronic Sutureless Pump Connector Revision Kit, model 8578, Method of Sterilization... | Medtronic Neuromodulation | LKK | ||
| Z-2075-2009 | Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC, Method of... | Medtronic Neuromodulation | LKK | ||
| Z-2074-2009 | Medtronic Intrathecal Catheter, model 8731SC, Method of Sterilization: Ethylene Oxide... | Medtronic Neuromodulation | LKK | ||
| Z-2073-2009 | Medtronic Indura 1P Intrathecal Catheter, model 8709SC, Method of Sterilization... | Medtronic Neuromodulation | LKK | ||
| Z-2246-2009 | Boston Scientific, Renegade Fiber Braided Microcatheter, Peripheral Vascular Use, RX... | Boston Scientific Corporation | KRA | ||
| Z-2245-2009 | Boston Scientific Renegade" Hi Flo Microcatheter (neurovascular use) REF 18-288OUS... | Boston Scientific Corporation | KRA | ||
| Z-2244-2009 | Boston Scientific Renegade" Hi-Flo Microcatheter, Peripheral Vascular Use. Sterilized... | Boston Scientific Corporation | KRA | ||
| Z-2212-2009 | Drager Surgical Lights Sola 500 and Sola 700. | Draeger, Inc. | FTD | ||
| Z-1229-2012 | Synchron CX Immuno-Protein Cal, part number: 442840, other product code: CKA The... | Siemens Healthcare Diagnostics Inc. | JIT | ||
| Z-1746-2010 | Trestle Anterior Cervical Plate 1-level assembly, Part Number: 61001-026. Alphatec... | Alphatec Spine, Inc. | KWQ | ||
| Z-0623-2010 | Cordis Aquatrack Hydrophilic Nitinol Guidewire, for use in angiographic procedures, REF... | Cordis US Corp. | DQX | ||
| Z-2072-2009 | Portex Polar Preformed Tracheal Tube, South Oral, Murphy Eye, Clear 3.5 mm Product Code... | Abbott Medical | BTR | ||
| Z-2071-2009 | Portex Polar Preformed Tracheal Tube, South Oral, Murphy Eye, Clear 3.0 mm Product Code... | Abbott Medical | BTR | ||
| Z-2070-2009 | Portex Tracheal Tube, Oral/Nasal, Murphy Eye, Clear, 3.5 mm Product Code... | Abbott Medical | BTR | ||
| Z-2069-2009 | Portex Tracheal Tube, Oral/Nasal, Murphy Eye, Clear, 3.0 mm Product Code... | Abbott Medical | BTR | ||
| Z-2068-2009 | Portex Tracheal Tube, Oral/Nasal, Murphy Eye, Clear, 2.5 mm Product Code... | Abbott Medical | BTR |