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-2196-2010 | ASCENT HEALTHCARE SOLUTIONS. Reprocessed Femoral Compression Device, Model 11165. | Stryker Sustainability Solutions | NMF | ||
| Z-2072-2010 | TomoTherapy Hi-Art System, ver. 4.0.0, 4.0.1, 4.0.2, ThomoTherapy Incorporated 1240... | Accuray Incorporated | MUJ | ||
| Z-0362-2011 | SoftBank Versions 23.1.2.x, 23.2.0.x, and 25.0.0.x with SoftReports. SCC Soft Computer... | SCC Soft Computer | MMH | ||
| Z-2333-2010 | BagEasy manual resuscitation devices are used for patients requiring complete or... | Westmed Inc | BTM | ||
| Z-2465-2010 | Spider Flex Monopolar Hook (Spider Surgical Instruments), TransEnterix, Inc., Durham, NC | Asensus Surgical, Inc. | GCJ | ||
| Z-2332-2010 | BagEasy manual resuscitation devices are used for patients requiring complete or... | Westmed Inc | BTM | ||
| Z-2121-2010 | MEDFUSION SYRINGE INFUSION PUMP, MODELS 3010 AND 3010a WITH SOFTWARE VERSIONS 2.0.2... | Abbott Medical | FRN | ||
| Z-2416-2012 | Class II | Kimberly-Clark MIC PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are... | Kimberly-Clark Corporation | KNT | |
| Z-2415-2012 | Class II | Kimberly-Clark MIC Safety PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull... | Kimberly-Clark Corporation | KNT | |
| Z-1743-2011 | SYNCHRON System(s) Chemistry RF Rheumatoid Factor Part Number 475136 RF reagent, when... | Siemens Healthcare Diagnostics Inc. | DHR | ||
| Z-2622-2010 | Stryker Scope Warmer, disposable. Endoscopic accessory composed of polyvinyl Chloride... | Stryker Corp. | GCJ | ||
| Z-0396-2011 | CIVCO Posifix Extension, REF MTIL6606, Reusable non-sterile extension for use with the... | Medtec LLC | IXQ | ||
| Z-0395-2011 | CIVCO Type-S Extension, REF MTIL6605, Reusable non-sterile extension for use with... | Medtec LLC | IXQ | ||
| Z-0394-2011 | CIVCO Rectangular Extension, REF MTIL6600, Reusable non-sterile extension for use with... | Medtec LLC | IXQ | ||
| Z-2232-2010 | Suture Lariat 45 Degree Dog Leg Up, QTY. 1, Biomet Sports Medicine, Warsaw, IN 46581... | Zimmer GmbH | MDM | ||
| Z-2231-2010 | Suture Lariat 30 Degree Up, QTY. 1, Biomet Sports Medicine, Warsaw, IN 46581. Sterile... | Zimmer GmbH | MDM | ||
| Z-2230-2010 | SpeedPass Disposable Suture Lariat with Nitinol Wire 25 Degree Right, QTY. 1, Biomet... | Zimmer GmbH | MDM | ||
| Z-2229-2010 | SpeedPass Disposable Suture Lariat with Nitinol Wire 25 Degree Left, QTY. 1, Biomet... | Zimmer GmbH | MDM | ||
| Z-2228-2010 | SpeedPass Disposable Suture Lariat with Nitinol Wire 45 Degree Up, QTY. 1, Biomet Sports... | Zimmer GmbH | MDM | ||
| Z-2075-2010 | Electrical Venous Occluder, Catalog 12-80-00, for use with Sorin HLM C5 and HLM S5. | LivaNova USA, Inc. | DWF | ||
| Z-2074-2010 | B-Care 5, Catalog 25-60-00, for use with Sorin HLM C5 and HLM S5. | LivaNova USA, Inc. | DTQ | ||
| Z-2073-2010 | Mast Roller Pump, Catalog 50-80-00, for use with Sorin HLM C5 and HLM S5. | LivaNova USA, Inc. | DTQ | ||
| Z-0307-2011 | WalkMed Triton Pole Mount Infusion Pump, Catalog 300000. Indicated for delivering... | WalkMed Technologies, LLC | FRN | ||
| Z-0900-2011 | Horizon Cardiology ECG Management This is a software application designed for use in... | Change Healthcare Technologies LLC | DQK | ||
| Z-2296-2012 | Class II | Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Extended... | Unimed Surgical Products, Inc. | GEI | |
| Z-2295-2012 | Class II | Product is labeled in part: "***MEDLINE***Standard PTFE Coated Blade with Extended... | Unimed Surgical Products, Inc. | GEI | |
| Z-2294-2012 | Class II | Product is labeled in part: "***MEDLINE***Extended 5mm PTFE Coated Ball 5.0 (12.70cm)... | Unimed Surgical Products, Inc. | GEI | |
| Z-2293-2012 | Class II | Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Extended... | Unimed Surgical Products, Inc. | GEI | |
| Z-2292-2012 | Class II | Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade 6.5 (16.51cm)... | Unimed Surgical Products, Inc. | GEI | |
| Z-2291-2012 | Class II | Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle with Extended... | Unimed Surgical Products, Inc. | GEI | |
| Z-2290-2012 | Class II | Product is labeled in part: "***MEDLINE***Staight Microsurgical Needle 3cm (1.81)... | Unimed Surgical Products, Inc. | GEI | |
| Z-2289-2012 | Class II | Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle 2.75" (6.99cm)... | Unimed Surgical Products, Inc. | GEI | |
| Z-2288-2012 | Class II | Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle with Extended... | Unimed Surgical Products, Inc. | GEI | |
| Z-2287-2012 | Class II | Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle 4.0" (10.16cm)... | Unimed Surgical Products, Inc. | GEI | |
| Z-2286-2012 | Class II | Product is labeled in part: "***MEDLINE***Extended PTFE Needle 6.5" (16.51cm)... | Unimed Surgical Products, Inc. | GEI | |
| Z-2213-2010 | DSD Application Guide (MG04-0001 revision M) for the Pentax Universal Video Scope Hookup... | Medivators Inc | FEB | ||
| Z-2407-2010 | Dimension Tacrolimus Flex Reagent Cartridge, manufactured by Siemens Healthcare... | Siemens Healthcare Diagnostics Inc. | MLM | ||
| Z-2177-2010 | Straumann Impression set for WN solid abutment H 4.00mm POM/ AI. Ref : 040.380 Kit... | Straumann USA, LLC | NDP | ||
| Z-0013-2011 | Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN... | Depuy Orthopaedics Inc. | LXH | ||
| Z-2029-2010 | Medtronic StealthStation S7 System | Medtronic Navigation, Inc | HAW | ||
| Z-1904-2010 | Hydradjust IV DR Urological Table Sedecal Generator (p/n 750732 - 64W generator & p/n... | Mallinckrodt, Inc. | IZO | ||
| Z-2209-2010 | Medtronic Carelink Monitor Model 2490C. The Medtronic CareLink Monitor Model 2490C is... | Medtronic, Inc. | NVZ | ||
| Z-2112-2010 | IMPAX CV Results Manager/Results Manager Administration Tool | AGFA Healthcare Corp. | LLZ | ||
| Z-2094-2010 | Rolko Trapeze handles, part 148671, for use with Care Assist bed P1170 and Hill Rom 1000... | Hill-Rom Inc. | FNL | ||
| Z-2060-2010 | Terumo HX2 Temperature Management System 120V, 50/60 Hz catalog number 809810, Terumo... | Terumo Cardiovascular Systems Corporation | DWC | ||
| Z-0973-2012 | Volcano pcFM Software Kit ; Manufactured by: Volcano Corporation, 2870 Kilgore Road... | Volcano Corporation | IYO | ||
| Z-2177-2011 | Siemens Dimension(R) EZCR Flex(R) Reagent Cartridge. Catalog number DF270B. In vitro... | Siemens Healthcare Diagnostics Inc. | JFY | ||
| Z-2154-2011 | Enzymatic Creatinine (ECREA) Flex(R) reagent cartridges, K1270 for the Dimension Vista(R)... | Siemens Healthcare Diagnostics Inc. | JFY | ||
| Z-1971-2011 | Precision 500D X-ray systems with under-table collimator part number 5234960. The... | GE Healthcare | JAA | ||
| Z-0886-2011 | Varian brand C-series Clinac, Trilogy and Novalis Tx, Software Versions 6.X and 7.X... | Varian Medical Systems, Inc. | GKZ |