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-0225-2009 | BD GeneOhm MRSA 200 ct, Catalog #441242. IDI-MRSA assay is a qualitative in vitro... | BD Diagnostics (Geneohm Sciences, Inc.) | NQX | ||
| Z-0524-2009 | IMMULITE/IMMULITE 1000 Progesterone (LKPG 1,5) For in vitro diagnostic use with the... | Siemens Healthcare Diagnostics Inc. | JLS | ||
| Z-2237-2010 | NeuViz Dual series Computed Tomography (CT) Scanner System, X-Ray System. Part Number... | Neuisys, LLC | JAK | ||
| Z-0174-2009 | Premier Value Lancing Device. UPC Code: 840986016707, The Package Includes: 1 Lancing... | Facet Technologies, LLC. | FMK | ||
| Z-2400-2008 | PLAC Test ELISA kit, catalog number 90106, enzyme immunoassay for the quantitative... | Diadexus, Inc. | NOE | ||
| Z-2399-2008 | PLAC Test Reagent Kit, Catalog numbers 90107 and 90110, Turbidimetric Immunoassay for the... | Diadexus, Inc. | NOE | ||
| Z-0521-2009 | Compress Short Anchor Plug Holder, 13mm, Biomet Orthopedics, Inc., Warsaw, IN; REF... | Zimmer GmbH | LXH | ||
| Z-0520-2009 | Compress Short Instruments Anchor Plug Holder, 12mm, stainless steel, non-sterile, Biomet... | Zimmer GmbH | LXH | ||
| Z-0519-2009 | Compress/Finn Instrument Set Compress Anchor Plug Assembly, stainless steel, Biomet... | Zimmer GmbH | LXH | ||
| Z-0518-2009 | Compress Instrument 13mm Anchor Plug Holder, stainless steel/TiAIN, Biomet Orthopedics... | Zimmer GmbH | LXH | ||
| Z-0517-2009 | Compress Instrument Anchor Plug Holder, stainless steel, Biomet Orthopedics, Inc... | Zimmer GmbH | LXH | ||
| Z-2373-2008 | Exact Calcar Planer Rasp Style Blade, 50mm, Biomet Orthopedics, Inc, Warsaw, IN; REF... | Zimmer GmbH | GFA | ||
| Z-2372-2008 | Exact Calcar Planer Rasp Style Blade, 46mm, Biomet Orthopedics, Inc, Warsaw, IN; REF... | Zimmer GmbH | GFA | ||
| Z-2371-2008 | Exact Calcar Planer Rasp Style Blade, 42mm, Biomet Orthopedics, Inc, Warsaw, IN; REF... | Zimmer GmbH | GFA | ||
| Z-2370-2008 | Exact Calcar Planer Rasp Style Blade, 38mm, Biomet Orthopedics, Inc, Warsaw, IN; REF... | Zimmer GmbH | GFA | ||
| Z-1652-2008 | Ultraview Digital Telemetry Transmitter, Model 90478 The Spacelabs Medical Digital... | GE Healthcare | DSI | ||
| Z-0357-2009 | Terumo Advanced Perfusion System 1 (6 inch diameter Roller Pump, Gray; Model... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0356-2009 | Terumo Advanced Perfusion System 1 (4 inch diameter Roller Pump, Gray; Model... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0310-2009 | Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041. The... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0309-2009 | Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040. The... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0206-2009 | Terumo Advanced Perfusion System 1 base; Model 801764. NOTE: This device is not sold in... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0205-2009 | Terumo Advanced Perfusion System 1 base, 110/120V; Model 801763. For use for up to 6... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0204-2009 | Terumo Advanced Perfusion System 1 base; Model 801764. NOTE: This product is not... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0203-2009 | Terumo Advanced Perfusion System 1 Base, 100/120V; Model 801763. For use for up to 6... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0355-2009 | Terumo Advanced Perfusion System 1 (6 inch diameter Roller Pump; Model... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0354-2009 | Terumo Advanced Perfusion System 1 (4 inch diameter Roller Pump; Model... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-1440-2012 | Synaptic 3600 and 3800 with Cranial Electrical Stimulation manufactured by Synaptic USA... | The Synaptic Corp. | GZJ | ||
| Z-2461-2008 | AMS 700 CX MS Pump IZ, Preconnect Penoscrotal, 18 cm, Sterile EO, REF 72404232, Lot... | American Medical Systems, Inc. | JCW | ||
| Z-2394-2008 | Apogee Intermittent Catheter with Coude tip, 14 Fr 16", Catalog/Ref No.1066, Sterile... | Robling Medical, LLC | GBM | ||
| Z-2393-2008 | Apogee Intermittent Catheter with Coude tip, 12 Fr 16", Catalog/Ref No. 1036, Sterile... | Robling Medical, LLC | GBM | ||
| Z-2392-2008 | Apogee Intermittent Catheter, 10 Fr 15", Catalog/Ref No. 1036, Sterile, Latex free. The... | Robling Medical, LLC | GBM | ||
| Z-2391-2008 | Apogee Intermittent Catheter, 8 Fr 16", Catalog/Ref No. 1018, Sterile, Latex free. The... | Robling Medical, LLC | GBM | ||
| Z-2390-2008 | Apogee Intermittent Catheter, 6 Fr 15", Catalog/Ref No. 1007, Sterile, Latex free. The... | Robling Medical, LLC | GBM | ||
| Z-2336-2008 | Ultraview Digital Telemetry Transmitter, Model 91341-09 The Spacelabs Medical Digital... | GE Healthcare | DSI | ||
| Z-0453-2009 | Angiotech, Bone Marrow Harvest Needle, Medical Device Technologies, Inc. The device is... | Medical Device Technologies, Inc. | KNW | ||
| Z-0452-2009 | Angiotech, T-Lok Bone Marrow Biopsy Needle, Medical Device Technologies, Inc. The device... | Medical Device Technologies, Inc. | KNW | ||
| Z-0451-2009 | Angiotech, Bone Marrow Biopsy Needle, Medical Device Technologies, Inc. The device is... | Medical Device Technologies, Inc. | KNW | ||
| Z-0450-2009 | Angiotech, Bone Marrow Aspiration Needle, Medical Device Technologies, Inc. Individual... | Medical Device Technologies, Inc. | KNW | ||
| Z-0213-2009 | GE Healthcare, Mobile Care Server used in conjunction with Web Viewer, Pocket Viewer, and... | GE Healthcare | MSX | ||
| Z-2300-2012 | Class II | Various SRI Surgical Disposable Accessory Packs. SRI's Disposable Accessory Packs (also... | SRI Healthcare, LLC | FTN | |
| Z-2374-2008 | BD 60 ml Syringe, Luer-Lok Tip Sterile; Cases : 160 (4 x 40) Shelf Carton: 40 BD... | Becton Dickinson & Co | FMF | ||
| Z-2403-2008 | Thin-Flex Venous Return Cannulae with Duraflo coating, REF DTF3343O, 33/43 Fr. x 39 cm... | Edwards Lifesciences LLC | DWF | ||
| Z-2402-2008 | Thin-Flex Venous Return Cannulae, 33/43 Fr. x 39 cm, REF TF3343OA, Sterile EO, Edwards... | Edwards Lifesciences LLC | DWF | ||
| Z-2401-2008 | Thin-Flex Venous Return Cannulae, 33/43 FR. x 39 cm, REF TF3343O, Sterile EO, Edwards... | Edwards Lifesciences LLC | DWF | ||
| Z-2337-2008 | HeartStarMRtX Defibrillator/Monitor Models: M3535A/M3536A HeartStart MRx with a native... | Philips North America LLC | MKJ | ||
| Z-0282-2009 | HT X-DRIVE SCREW, Part # 91-2416, W.Lorenz Surgical. Screws for use in the... | Biomet Microfixation | JEY | ||
| Z-2375-2008 | FormPutty Bone Void Filler 10cc The product is sealed in a foil pouch and then placed... | Theken Companies LLC | MQV | ||
| Z-0539-2009 | Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42+6R RET, sterile, Depuy France; REF... | Depuy Orthopaedics Inc. | KWS | ||
| Z-0538-2009 | Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42/+9 STD, sterile, Depuy France; REF... | Depuy Orthopaedics Inc. | KWS | ||
| Z-0537-2009 | Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42/+6 STD, sterile, Depuy France; REF... | Depuy Orthopaedics Inc. | KWS |