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-0638-2007 | VIASYS VELA Ventilator, Catalog Number-16186; Viasys Respiratory Care, Inc. | ZOLL Palm Springs | CBK | ||
| Z-0686-2007 | Aspyra, Inc. CyberMED Version 2.1 Pharmacy Software | Aspyra, LLC. | NXS | ||
| Z-0575-2007 | StarClose Vascular Closure System (Clip Applier & Exchange System), Catalog Number... | Abbott Vascular | DYB | ||
| Z-0519-2007 | The recalled product is the Large grid biopsy plate, part #2414797. The biopsy plate is... | GE Healthcare Coils | LNH | ||
| Z-0518-2007 | The recalled product is the Disposable biopsy plate, part #U1-150131. The biopsy plate is... | GE Healthcare Coils | LNH | ||
| Z-0517-2007 | The recalled product is the Lateral biopsy plate, part #2414346. The biopsy plate is... | GE Healthcare Coils | LNH | ||
| Z-0516-2007 | The recalled product is the medial biopsy plate, part #2414342. The biopsy plate is... | GE Healthcare Coils | LNH | ||
| Z-0921-2007 | IMS Patient Scale used on Sunrise Medical's Hoyer Presence and Stature Patient Lifts... | Integrated Measurement Systems, Inc. | FRW | ||
| Z-0700-2007 | The Precision Implantable Pulse Generator, Model Number SC-1110 | Advanced Bionics LLC | LGW | ||
| Z-0723-2007 | Hamilton brand Disposable Precision Tips, Part Number 235300 (box containing 504 tips)... | Hamilton Co | -JTC | ||
| Z-0722-2007 | Clinical Chemistry Phosphorus in vitro diagnostic, List Number: 7D71-30 and 7D71-20 | Abbott Medical | CEO | ||
| Z-0549-2007 | Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed... | Siemens Medical Solutions USA, Inc. | JAK | ||
| Z-0548-2007 | Symbia S Series SPECT (Single-Photon Emission Computed Tomography) System with a Pinhole... | Siemens Medical Solutions USA, Inc. | KPS | ||
| Z-0582-2007 | BD Integra 1ml Insulin Syringe with Retracting Precision Guide Needle 1 ml 29g 1/2''... | Becton Dickinson & Co | FMF | ||
| Z-0685-2007 | Plicator EPS Plication System Catalog Number: 160-01128R | Ndo Surgical, Inc. | KOG | ||
| Z-0674-2007 | Medical Air Compressor Model #8413419 | Draeger, Inc. | BTI | ||
| Z-0539-2010 | Holding Forceps for Trident Acetabular System; non Sterile; Catalog number... | Howmedica Osteonics Corp | HTD | ||
| Z-0280-2008 | GE Healthcare CIC Pro Clinical Information Center, Central Station, Software Version 4.1... | GE Medical Systems Information Technologies, Inc. | DSI | ||
| Z-0732-2007 | 535D-X CF Continuous Flow Cylinder | Sunrise Medical, Inc. | NFB | ||
| Z-0646-2007 | Thyrotest TSH POC Rapid membrane test. In vitro diagnostic. | ThyroTec Inc | JLW | ||
| Z-0891-2007 | GE Healthcare CIC Pro Clinical Information Center, Central Station, Software Version 4.1... | GE Medical Systems Information Technologies, Inc. | DSI | ||
| Z-0691-2007 | HTA Console System, 230 Volt , Italian, Product Number: 56001 IO (HTA system is a... | Boston Scientific Corporation | MNB | ||
| Z-0690-2007 | HTA Console System, 230 Volt , French, Product Number: 56001FO (HTA system is a... | Boston Scientific Corporation | MNB | ||
| Z-0689-2007 | HTA Console System, 230 Volt, Product Number: 56001 DO- English Demonstration Evaluation... | Boston Scientific Corporation | MNB | ||
| Z-0688-2007 | HTA Console System, 230 Volt, English, Product Number: 560010 (HTA system is a... | Boston Scientific Corporation | MNB | ||
| Z-0687-2007 | HTA Console System, 110 Volt, Product Number: 56000 (HTA system is a... | Boston Scientific Corporation | MNB | ||
| Z-0520-2007 | Quantum TTC Biliary Balloon Dilation Catheter, Wilson Cook Medical, GI Endoscopy, 4900... | Wilson-Cook Medical Inc. | KNQ | ||
| Z-0731-2007 | DeVilbiss PD1000A Pulse Dose Oxygen Conserving Cylinder | Sunrise Medical, Inc. | NFB | ||
| Z-1234-2008 | Nautica (GK) Mattress Stretcher, manufactured by Georg Kramer GES.M.B.H. & CO. KG A-4061... | Arjo, Inc. | FSA | ||
| Z-0576-2007 | AccuGuide Injection Needles (Surface electrodes) The AccuGuide EMG Injection Needle... | Medtronic Xomed, Inc. | GZX | ||
| Z-0782-2007 | SOPRO Camera Control Units, PAL, SV420P, REF (Catalog) #72200506 v1.1; Made in France... | Smith & Nephew, Inc. | FWF | ||
| Z-0781-2007 | SOPRO Camera Control Units, NTSC, SV420P; REF (Catalog) #72200505 v1.1; Made in France... | Smith & Nephew, Inc. | FWF | ||
| Z-0673-2007 | Prostate Biopsy Needle, Model: NAC-1825BB, Soxe 18 GA x 25 CM, Single use, Ethylene... | Remington Medical | KNW | ||
| Z-0718-2007 | Deltec branded CADD-Prizm PCS II ambulatory infusion pump and the CADD-Prizm VIP system... | Abbott Medical | FRN | ||
| Z-0553-2007 | Clark Biocompatible Hemoperfusion Cartridge, sorbent: Heparinized polymer over... | Clark Research and Development, Inc. | FLD | ||
| Z-0552-2007 | Clark Biocompatible Hemoperfusion Cartridge, Sorbent: Heparinized polymer over... | Clark Research and Development, Inc. | FLD | ||
| Z-0551-2007 | Clark Biocompatible Hemoperfusion Cartridge, Sorbent: Heparinized polymer over... | Clark Research and Development, Inc. | FLD | ||
| Z-0550-2007 | Clark Biocompatible Hemoperfusion Cartridge, Sorbent: Heparinized polymer over... | Clark Research and Development, Inc. | FLD | ||
| Z-0664-2007 | RF Denervation Probe, 15 cm, temperature sensing electrodes designed for use in... | Smith & Nephew, Inc. | GXI | ||
| Z-0663-2007 | RF Denervation Probe, 10 cm, temperature sensing electrodes designed for use in... | Smith & Nephew, Inc. | GXI | ||
| Z-0662-2007 | RF Denervation Probe, 5cm, temperature sensing electrodes designed for use in... | Smith & Nephew, Inc. | GXI | ||
| Z-0428-2007 | Taut Intraducer Peritoneal Catheter, 12 Fr x 10 Fr x 20.3 cm; a sterile, Rx peritoneal... | Taut, Inc. | GBW | ||
| Z-0497-2007 | Salivart Oral Moisturizer, packaged in 2.5 fluid ounce (73.9 mL) spray cans, Part Number... | Gebauer Co | LFD | ||
| Z-0448-2009 | Homocysteine Reagent Test Kit. The Homocysteine test kits were manufactured under 2... | Catch Incorporated | LPS | ||
| Z-0812-2007 | STA Compact and STA Compact CT For in vitro Diagnostic Use Only In vitro diagnostic... | Diagnostica Stago, Inc. | GKP | ||
| Z-0610-2007 | 19 Gauge Trocar Cannula Replacement Plug, Catalog Number 617.32; Manufactured by Alcon... | Alcon Laboratories | NGY | ||
| Z-0487-2015 | Class II | Cannulaide, Model 101. The Cannulaide product is composed of die-cut hydrocolloid coated... | Beevers Manufacturing & Supply, Inc. | BZD | |
| Z-0705-2007 | ABL800 FLEX Series analyzer with FLEXQ module-equipped with software version 5.2 to 5.27 | Radiometer America, Inc | CHL | ||
| Z-0515-2007 | OEC Uroview 2800 fluoroscopic x-ray system with 3 Phase Power Distribution Box option... | GE Healthcare | JAA | ||
| Z-0514-2007 | OEC Uroview 2800 with Dual Monitor Option, fluoroscopic x-ray system, Model Numbers... | GE Healthcare | JAA |