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-0536-2009 | Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42/+3 STD, sterile, Depuy France; REF... | Depuy Orthopaedics Inc. | KWS | ||
| Z-0535-2009 | Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 38/+6R RET, sterile, Depuy France; REF... | Depuy Orthopaedics Inc. | KWS | ||
| Z-0534-2009 | Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 38/+9 STD, sterile, Depuy France; REF... | Depuy Orthopaedics Inc. | KWS | ||
| Z-0533-2009 | Depuy DELTA Xtend, Standard Humerus PE Cup, Dia 38/+6 STD, sterile, Depuy France; REF... | Depuy Orthopaedics Inc. | KWS | ||
| Z-0532-2009 | Depuy DELTA Xtend, Standard humeral PE Cup Dia 38/+3 STD, sterile, Depuy France; REF... | Depuy Orthopaedics Inc. | KWS | ||
| Z-2405-2008 | Synchron Acetaminophen (ACTM) Reagent, Part Number 472169. ACTM Reagent when used in... | Siemens Healthcare Diagnostics Inc. | LDP | ||
| Z-2368-2008 | 12ml Control Syringe / Smart Tip, REF/CAT No.: ST601, Sterile EO, Merit Medical Systems... | Merit Medical Systems, Inc. | FMF | ||
| Z-2367-2008 | 12ml Control Syringe, REF/CAT No.: CCS601 Version B, Sterile R, Merit Medical Systems... | Merit Medical Systems, Inc. | FMF | ||
| Z-2366-2008 | 10ml Control Syringe, REF/CAT No.: CCX011 Version A, Sterile EO, Merit Medical Systems... | Merit Medical Systems, Inc. | FMF | ||
| Z-2194-2010 | The Philips EasyDiagnost Eleva with DRF. Philips Medical Systems multifunctional x-ray... | Philips North America LLC | KPR | ||
| Z-2348-2008 | Isotechnology, Isobalance System; Serial Numbers: 07-030. The product was being... | Acacia Engineered Products LLC | LXV | ||
| Z-1154-2010 | Stableloc (TM) Wrist External Fixation System, Quantity 1. Packaged labeled, "Stableloc... | Acumed LLC | JEC | ||
| Z-2443-2008 | SERVO-s Ventilator System, Maquet Critical Care, Solna, Sweden. The product is intended... | Maquet Cardiovascular Us Sales, LLC | CBK | ||
| Z-2442-2008 | SERVO-i Ventilator System Maquet Critical Care, Solna, Sweden. The product is intended... | Maquet Cardiovascular Us Sales, LLC | CBK | ||
| Z-2345-2008 | Power Board Kit for use with the PLV-100 Portable Lifecare repairs | Respironics, Inc. | CBK | ||
| Z-2344-2008 | PLV-100 Portable Lifecare Ventilator Life support ventilation The device is intended to... | Respironics, Inc. | CBK | ||
| Z-2441-2008 | MONARCH II IOL Delivery System, Cartridge Model B, part #8065977758, packaged in pouches... | Alcon Laboratories | KYB | ||
| Z-2433-2008 | BD Visitec Disposable Instrument (plastic handle) Capsulorhexis Forceps, Sterile Ref... | Becton Dickinson & Co | HNR | ||
| Z-2398-2008 | Centros(TM) 15F x 32cm Chronic Hemodialysis Curved Catheter Set (With Cuff 27cm From... | Boston Scientific Corporation | MSD | ||
| Z-2397-2008 | Centros(TM) 15F x 28cm Chronic Hemodialysis Curved Catheter Set (With Cuff 23cm From... | Boston Scientific Corporation | MSD | ||
| Z-2396-2008 | Centros(TM) 15F x 24cm Chronic Hemodialysis Curved Catheter Set (With Cuff 19cm From... | Boston Scientific Corporation | MSD | ||
| Z-2298-2008 | Zimmer Freestanding Patient Helper for Hill-Rom Totalcare beds; Zimmer Inc., Warsaw, IN... | Zimmer GmbH | IKX | ||
| Z-2297-2008 | Zimmer Patient Helper Reinforce Overhead Bar for Hill-Rom Versa Care beds; Zimmer Inc... | Zimmer GmbH | IKX | ||
| Z-2338-2008 | Fabius Trio Gas machine, anesthesia or analgesia. Catalog number 8606000. The product... | Draeger, Inc. | BSZ | ||
| Z-2335-2008 | Radiation Reduction Gloves, sterile, Latex-free, Catalog No. SSR1-7.0, SSR1-7.5... | Integra Pain Management | LZC | ||
| Z-2296-2008 | Zimmer Patient Helper Reinforced Overhead Bar for Hill-Rom beds with removable... | Zimmer GmbH | IKX | ||
| Z-0976-2009 | Turbo Elite 0.9mm Turbo Elite (TE) RX, Model #410-154, tip diameter 0.9mm/.038 in, 4 Fr... | Spectranetics Corp. | MJQ | ||
| Z-0116-2009 | Artiste MV system, Part number 8139789, medical linear accelerator equipped with... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0130-2009 | Oscor Adelante Luer-Lock Peel Away Introducer Set, for introduction of diagnostic or... | Oscor Inc. | DYB | ||
| Z-2346-2008 | Philips Healthcare Informatics iSite PACS (Picture Archiving and Communications System)... | Philips North America LLC | LLZ | ||
| Z-1709-2008 | GE OEC 9600 C-arm Fluoroscopy System, GE Healthcare, Surgery, Salt Lake City, Utah. | GE Healthcare | JAA | ||
| Z-0212-2009 | BioStar OIA FLU AB, Catalog 90007. Packaged 30 devices per tray. BioStar, Louisville, CO... | Inverness Medical-Biostar, Inc. | GNX | ||
| Z-2379-2008 | VERTIER Surgical Table, Catalog #0788-100-001S (SIDNE-enabled standard table with 5th... | STRYKER Communications, Inc. | FQO | ||
| Z-2378-2008 | VERTIER Surgical Table, Catalog #0788-100-000S (SIDNE-enabled standard table)... | STRYKER Communications, Inc. | FQO | ||
| Z-2377-2008 | VERTIER Surgical Table, Catalog #0788-100-001 (Standard table with 5th wheel)... | STRYKER Communications, Inc. | FQO | ||
| Z-2376-2008 | VERTIER Surgical Table, Catalog #0788-100-000 (Standard table); distributed by Stryker... | STRYKER Communications, Inc. | FQO | ||
| Z-0115-2009 | Scorpio Series 7000 Tibial Impactor/Extractor, Catalog number 3770-000 Non... | Howmedica Osteonics Corp | HWA | ||
| Z-2332-2008 | Cotton-Leung Biliary Stent. CLSO-10-10, Stent Length:10cm in length, Disposable-Single... | Wilson-Cook Medical Inc. | FGE | ||
| Z-2331-2008 | Cotton-Leung Biliary Stent., CLSO-10-5, Stent Diameter: 10 FR, Stent Length: 5cm... | Wilson-Cook Medical Inc. | FGE | ||
| Z-2328-2008 | Integra Dermal Regeneration Template; 8 x 10 in (20 cm x 25 cm) , Sterile; Integra... | Integra LifeSciences Corporation | MDD | ||
| Z-2327-2008 | Evita XL Critical Care Ventilator. Continuous (Respirator) | Draeger, Inc. | CBK | ||
| Z-2326-2008 | Evita 4 Critical Care Ventilator. Continuous (Respirator) | Draeger, Inc. | CBK | ||
| Z-2325-2008 | Evita 2 dura Critical Care Ventilator. Continuous (Respirator) | Draeger, Inc. | CBK | ||
| Z-2314-2008 | Spacelabs Medical Temperature Probe Adaptor PN-700-0031-00. Device is packaged in clear... | GE Healthcare | DSI | ||
| Z-2147-2008 | GE Stereotaxy Positioner, model 2405544-3, for use with Senographe DS Full Field... | GE Healthcare | IZH | ||
| Z-2146-2008 | GE Stereotaxy Positioner, model 2405544-2, for use with Senographe DS Full Field... | GE Healthcare | IZH | ||
| Z-1548-2008 | ev3" sterile EO, single Use, Visi-Pro Balloon-Expandable Biliary Stent System. Model... | Medtronic, Inc. | FGE | ||
| Z-1547-2008 | ev3" 55442-2920, sterile EO, single Use, Visi-Pro Balloon-Expandable Peripheral Stent... | Medtronic, Inc. | FGE | ||
| Z-2320-2008 | Universal SlingBar 600 with Quick-release Hook Product Number: 3156086 Used in... | Liko AB | FSA | ||
| Z-2319-2008 | Universal SlingBar 450 with Quick-release Hook Product Number: 3156085 Used in... | Liko AB | FSA |