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-0836-05 | Centurion brand CirClamp with 1.3 cm bell, sterile, single use; product 330. | Centurion Medical Products, LP | HFX | ||
| Z-1153-2007 | ISOLOC Software Version 6.0, Localization software for determining treatment machine... | Northwest Medical Physics Equipment, Inc. | IYE | ||
| Z-0326-06 | Disposable Tips 1000 l with filter Conductive disposable tips for Tecan Genesis Series *... | Tecan U.S. | JQW | ||
| Z-0797-05 | Altaire, Magnetic Resonance Imaging Device. | FUJIFILM Healthcare Americas Corporation | LNH | ||
| Z-0796-05 | Axiom Artis X-Ray System using software version VB11D or VB20B | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-0929-05 | Animas IR 1250 Insulin Pump. | Animas Corp. | LZG | ||
| Z-0823-05 | LifeScan Brand InDuo Blood Glucose Meter | Lifescan, Inc. | NBW | ||
| Z-0822-05 | LifeScan brand OneTouch FastTake Blood Glucose Meter | Lifescan, Inc. | NBW | ||
| Z-0821-05 | LifeScan brand OneTouch Ultra Blood Glucose Meter | Lifescan, Inc. | NBW | ||
| Z-0529-06 | Lumenis brand Lumenis One System with Multi-Spot Nd:YAG, LightSheer and Universal IPL... | Lumenis Ltd | GEX | ||
| Z-0776-05 | DiaSorin ETI-HA-IGMK PLUS Enzyme Immunoassay for the Detection of IgM Antibody to... | Diasorin Inc. | LOL | ||
| Z-0817-05 | KODAK GP FLEXIBLE PHOSPHOR SCREENS, for use with Kodak DirectView CR 500 systems... | Eastman Kodak Company | IXJ | ||
| Z-0840-05 | Dunlee DA 200 Ultra & MX 200 Ultra CT X-Ray Tube Housing Assembly (989600088701)... | Chronos Imaging, LLC | ITY | ||
| Z-0839-05 | Dunlee DA 200 PRO & MX 200 PRO CT X-Ray Tube Housing Assembly (989600088401); replacement... | Chronos Imaging, LLC | ITY | ||
| Z-0810-05 | Bio-Intact PTH (1-84) Assay, Catalog No. 62-7040 | Nichols Institute Diagnostics | CEW | ||
| Z-0838-05 | Dunlee DA 200 & MX 200 CT X-Ray Tube Housing Assembly (989600087501); replacement x-ray... | Chronos Imaging, LLC | ITY | ||
| Z-0973-05 | Smith & Nephew Grasper, Cupped 3.4mm REF: 011014 | Smith & Nephew, Inc. | GDJ | ||
| Z-0819-05 | ECAT PET Scanners (mobile systems), distributed by Siemens Medical Solutions ECAT PET... | Siemens Medical Solutions USA, Inc. | KPS | ||
| Z-0893-06 | Life Pulse High Frequency Ventilator (HFV) | Cutler Campus | LSZ | ||
| Z-0011-06 | Allocraft TLIF Bone Inserter. | Howmedica Osteonics Corp | LXH | ||
| Z-0818-05 | Axiom Artis MP X-Ray System | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-0699-05 | BCP-7A, Quick Silver Bipolar Coagulation Probe, For use w/dual Plug Bipolar Generators *... | Wilson-Cook Medical Inc. | GCJ | ||
| Z-0698-05 | ESD-5, ESD Flexible Endoscopic Suturing Device, Flexible Sew Right Device: Flexible TI... | Wilson-Cook Medical Inc. | GCJ | ||
| Z-0792-05 | Terumo Clirans Series EE Excebrane Hollow Fiber Dialyzers; a wet model single use... | Asahi Kasei Medical MT Corp. Oita Works | KDI | ||
| Z-0791-05 | Terumo Clirans Series E Excebrane Hollow Fiber Dialyzers; a wet model single use dialyzer... | Asahi Kasei Medical MT Corp. Oita Works | KDI | ||
| Z-0793-05 | Stryker brand Birthing Bed; Model 4701. | Stryker Medical | HDD | ||
| Z-0850-05 | Sodasorb Carbon Dioxide Absorbent, Medical Grade (16%) Soda Lime USP-NF with an ethyl... | Darex Container Products Div of W.R. Grace & Co. | CBL | ||
| Z-0790-05 | Asahi APS Series Hollow Fiber Dialyzers; a wet model mutiple use dialyzer consisting of... | Asahi Kasei Medical MT Corp. Oita Works | KDI | ||
| Z-0789-05 | Asahi AM-BIO-HX Extended Range Series Hollow Fiber Dialyzers; a wet model single use... | Asahi Kasei Medical MT Corp. Oita Works | KDI | ||
| Z-0788-05 | Asahi AM-BIO Series Hollow Fiber Dialyzers; a wet model multiple use dialyzer consisting... | Asahi Kasei Medical MT Corp. Oita Works | KDI | ||
| Z-1391-05 | Regius-IM. The Regius Image Manager for Centralized workflow and improved image quality... | Konica Minolta, Inc. | LMA | ||
| Z-0857-05 | Mick TP Prostate Seeding Needles, 18 Gauge, Catalog/Model Number MTP-1820-C. --- BRAND... | Mick Radio-Nuclear Instruments, Inc. | IWF | ||
| Z-1530-05 | Clinac (linear accelerator); Model 21EXS Silhouette Machine (slim version of the... | Varian Medical Systems, Inc. | IYE | ||
| Z-0775-05 | STAAR Phaco Tubing Kit | Staar Surgical AG | GDY | ||
| Z-0800-05 | Baxter Spinal Anesthesia Trays; sterile, single use only procedure trays that contain BD... | Baxter Healthcare Corporation | CAZ | ||
| Z-0100-06 | Roche CoaguChek S System Controls; Catalog number 3033384, part numbers 010018501 and... | Roche Diagnostics GmbH | GJS | ||
| Z-0099-06 | Roche CoaguChek System Controls; Catalog number 7745, Part numbers 054207608 and... | Roche Diagnostics GmbH | GJS | ||
| Z-0098-06 | Roche CoaguChek System Controls (patient self testing); Catalog number 763, Part numbers... | Roche Diagnostics GmbH | GJS | ||
| Z-0911-05 | Lover brand lubricated latex condoms, spermicidal, Nuevo Innovations, Farmingdale, NY... | Harmony Brands LLC | |||
| Z-0288-06 | 16 G / 5F Dual Lumen L-Cath complete kit with U-Wing | Becton Dickinson Infusion Therapy Systems Inc. | LJS | ||
| Z-0287-06 | 16 G / 5F Dual Lumen L-Cath Basic Kit with U-Wing | Becton Dickinson Infusion Therapy Systems Inc. | LJS | ||
| Z-0286-06 | 16 G / 5F Dual Lumen L-Cath Complete Kit with Introsyte | Becton Dickinson Infusion Therapy Systems Inc. | LJS | ||
| Z-0285-06 | 16 G / 5F Dual Lumen L-Cath Basic Kit with Introsyte | Becton Dickinson Infusion Therapy Systems Inc. | LJS | ||
| Z-0284-06 | 16 G / 5F Dual Lumen L-Cath Complete Kit with Introsyte Autoguard | Becton Dickinson Infusion Therapy Systems Inc. | LJS | ||
| Z-0283-06 | 16 G / 5F Dual Lumen L-Cath Basic Kit with Insyte Autoguard | Becton Dickinson Infusion Therapy Systems Inc. | LJS | ||
| Z-0282-06 | 16 G / 5F Dual Lumen L-Cath catheter only. | Becton Dickinson Infusion Therapy Systems Inc. | LJS | ||
| Z-1068-05 | Sequoia Oxymatic electronic oxygen conservers. Models OM-302, OM-311 ***and OM-312***. | Chad Therapeutics, Inc. | BZD | ||
| Z-0910-05 | Lover brand lubricated latex condoms in various presentations, Nuevo Innovations... | Harmony Brands LLC | |||
| Z-0909-05 | B-Sure brand one step home pregnancy test distributed by Harmony Brands Inc., Melvindale... | Harmony Brands LLC | LCX | ||
| Z-0809-05 | Nichols IRMA Intact PTH Assay, catalog No. 40-2171 | Nichols Institute Diagnostics | CEW |