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-0194-2009 | Axiom Artis Zee. Angiographic X-ray System. | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-0193-2009 | AXIOM Artis. Angiographic X-ray System. | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-0407-2009 | Mentor Aseptic Transfer Set, Cat. #350-8400 (contains BD 60mL Luer-Lok Syringe). Aseptic... | Mentor | GAZ | ||
| Z-0102-2009 | Syngo Imaging with versions VB20B, VB20D, VB20F, VB20G, VB25B, VB30A, VB30A_SP1, and... | Siemens Medical Solutions USA, Inc. | LLZ | ||
| Z-0159-2009 | WECK Hem-o-lok Non-absorbable Polymer Ligation Clips, Rx Only, Sterile, Teleflex Medical... | Teleflex Medical | FZP | ||
| Z-0158-2009 | Weck , Horizon Titanium Clips, Rx Only, Sterile, Teleflex Medical, RTP, NC 27709, USA... | Teleflex Medical | FZP | ||
| Z-0157-2009 | Weck Hemoclip Plus Ligating Clips, Rx Only, Sterile, Teleflex Medical, RTP, NC 27709 USA... | Teleflex Medical | FZP | ||
| Z-0156-2009 | Weck Hemoclip Traditional Ligating Clips, Rx Only, Sterile, Teleflex Medical, RTP, NC... | Teleflex Medical | FZP | ||
| Z-0087-2009 | Draeger Medical Apollo Anesthesia Machine, catalog number 8606500 | Draeger, Inc. | BSZ | ||
| Z-0125-2011 | Allura Xper FD10/10 Biplane X-ray system. Intended for use in cardiovascular and vascular... | Philips North America LLC | IZI | ||
| Z-0124-2011 | Allura Xper FD10 Monoplane X-ray system. Intended for use in cardiovascular and vascular... | Philips North America LLC | IZI | ||
| Z-0155-2009 | Allez Spine Cross Connectors; Catalog Number: LG-CC1001Cross Link, Small 30-37mm... | Allez Spine, LLC | NKB | ||
| Z-0154-2009 | Allez Spine Del Mar Pedicle Screw System; Catalog Number: IT-FN1001 Laguna Pedicle Screw... | Allez Spine, LLC | NKB | ||
| Z-0153-2009 | Allez Spine Laguna Pedicle Screw System; Catalog Number: IT-FN1003 Del Mar Pedicle Screw... | Allez Spine, LLC | MNI | ||
| Z-1552-2010 | Intramedullary Fixation Rod, common name Fibula Rod, labeled IM Rod System Manufactured... | Acumed LLC | HSB | ||
| Z-0227-2009 | Hipstar V40 Femoral Stem Howemedica: Benoist Girard et Cie; 203 bd de la Grande Selle... | Howmedica Osteonics Corp | LZO | ||
| Z-0908-2010 | Rubella IgG EIA test kit, containing 1 Rubella IgG Microplate, 1 Negative Control, 1 High... | Bio-Rad Laboratories Inc. | LFX | ||
| Z-0279-2009 | Outback LTD Re-Entry Catheter, Sterile, Single Use. The Cordis LuMend OUTBACK LTD... | Cordis US Corp. | MCW | ||
| Z-0985-2009 | Orthosoft Navitrack, OS Unicondylar Knee 1.0 - Universal; software application for... | Zimmer GmbH | HAW | ||
| Z-1089-2009 | Sm ELISA Test System Product number 2Z2831G and Product number 43270CE Individual... | Zeus Scientific LLC | LJM | ||
| Z-0086-2009 | Siemens Ultrasound, Acuson/Sonovista X300 ultrasound systems, software revisions... | Siemens Medical Solutions USA, Inc. | IYN | ||
| Z-0111-2009 | Siemens Ultrasound, Acuson/Sonovista X300 ultrasound systems, software revisions 2.0.1 to... | Siemens Medical Solutions USA, Inc. | IYN | ||
| Z-0531-2009 | Mainline Confirms hCG urine pregnancy test, Mainline Technologies, Inc., Ann Arbor, MI... | Mainline Technology, Inc. | JHI | ||
| Z-0530-2009 | f.y.i. hCG Urine one-step pregnancy test, Carmel Diagnostics, LLC, Naples, FL; Catalog #... | Mainline Technology, Inc. | JHI | ||
| Z-0217-2009 | Reflex Hybrid 4.0 x 14 mm Variable, Self-Tapping Bone Screw (Non- sterile). Manufactured... | Howmedica Osteonics Corp | KWQ | ||
| Z-0151-2009 | Ray TFC Device with End Caps: Single Patient use; Sterile; Stryker Spine Ray Cage 7-2021... | Howmedica Osteonics Corp | MAX | ||
| Z-0529-2009 | Mainline Confirms hCG Serum/Urine III, Mainline Technologies, Inc., Ann Arbor, MI... | Mainline Technology, Inc. | JHI | ||
| Z-0528-2009 | Mainline hCG Accuracy Check, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 3c1001. | Mainline Technology, Inc. | JHI | ||
| Z-0527-2009 | Mainline Confirms III Serum/Urine control set, Mainline Technologies, Inc., Ann Arbor... | Mainline Technology, Inc. | JHI | ||
| Z-0526-2009 | Mainline Confirms Strep A DOTS, Mainline Technologies, Inc., Ann Arbor, MI; Catalog #... | Mainline Technology, Inc. | JHI | ||
| Z-0525-2009 | Mainline Confirms Strep A, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 3030-20... | Mainline Technology, Inc. | JHI | ||
| Z-0012-2011 | Essenta DR is a digital multifunctional X-ray systems, suitable for all routine... | Philips North America LLC | KPR | ||
| Z-1709-2009 | Disposable Pack, Headset Part Number 888946-01(kit includes Part Number 888944-01... | GE Healthcare | MMP | ||
| Z-1708-2009 | Sterile, Drape, Headset, Upper, Part Number 888945-01. | GE Healthcare | MMP | ||
| Z-1707-2009 | Sterile, Drape, Headset, Lower, Part Number 888944-01. | GE Healthcare | MMP | ||
| Z-1706-2009 | GE Medical Systems, OEC, Vascular Drape, 00-902776-01, Sterile. 150" long x 87" wide... | GE Healthcare | MMP | ||
| Z-0191-2009 | Stryker Osteosynthesis Reduction Spoon; 1 single unit to a package; non-sterile; Stryker... | Howmedica Osteonics Corp | LXH | ||
| Z-0971-2009 | 3.7 V Li-Polymer Battery, used in Precess MRI Compatible Patient Monitoring System and... | Invivo Corporation | MWI | ||
| Z-1885-2008 | GE OEC 9900 Elite Fluoroscopic X-Ray System, GE Healthcare, Surgery, Salt Lake City... | GE Healthcare | JAA | ||
| Z-1884-2008 | GE OEC 9800 Fluoroscopic X-Ray System, GE Healthcare, Surgery, Salt Lake City, Utah. The... | GE Healthcare | JAA | ||
| Z-0101-2009 | AXIOM Luminos TF, model number 10093902 Intended to be used for procedures that involve... | Siemens Medical Solutions USA, Inc. | MQB | ||
| Z-0523-2009 | Philips Diagnostic Ultrasound System, Model HDI4000. Product labeled HDI4000 Ultrasound... | Philips North America LLC | IYN | ||
| Z-0522-2009 | Philips Diagnostic Ultrasound System, Model HD3. Product labeled HD3 Ultrasound System... | Philips North America LLC | IYN | ||
| Z-0148-2009 | NEUROSTAR TOP X-Ray System, Model numbers 6258425 and 6379668. | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-0147-2009 | NEUROSTAR X-Ray System, Model number 6134741. | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-0146-2009 | BICOR TOP X-Ray System, Model number 6134816. | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-0145-2009 | BICOR POLYDOROS X-Ray System, Model number 6134667. | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-0144-2009 | COROSKOP HS-ACS X-Ray System, Model number 6134659. | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-0143-2009 | BICOR HS X-Ray System, Model number 6005776 | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-0142-2009 | MULTISTAR POLYDOROS X-Ray System, Model number 2845001 | Siemens Medical Solutions USA, Inc. | IZI |