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-0903-05 | Pronto Series Power Wheelchair, model M61. | Invacare GmbH | ITI | ||
| Z-0902-05 | Pronto Series Power Wheelchair, model M51. | Invacare GmbH | ITI | ||
| Z-0901-05 | Pronto Series Power Wheelchair, model M50. | Invacare GmbH | ITI | ||
| Z-0873-05 | Nichols Advantage Sample hGH Diluent Set (Catalog No. 62-7756) | Nichols Institute Diagnostics | CFL | ||
| Z-0884-05 | IRISpec CA/ IRISpec CB Two-Part Urine Chemistry Control Twin Set, part no. 800-0074. | International Remote Imaging Systems | JJW | ||
| Z-0896-05 | View Forum 2003 software, SW 3.4L1 | Philips North America LLC | LLZ | ||
| Z-0848-05 | Philips Medical HeartStart MRx Monitor/Defibrillator Model: M3535A, M3536A | Philips North America LLC | MKJ | ||
| Z-0805-05 | LAERDAL ADAPTER CABLE, Cat. No. 920650. The cables allow the use of the Laerdal... | Laerdal Medical a/S | LDD | ||
| Z-1152-2007 | ISOLOC Software Versions 6.0 and 4.2. Part Number NT-NW-425-520. Image guided... | Northwest Medical Physics Equipment, Inc. | IYE | ||
| Z-0116-2007 | Venoscope Neonatal Transilluminator, Model NT01 | Venoscope LLC | HJN | ||
| Z-1527-05 | Electrophysiology Imaging System | Fischer Imaging Corp. | JAA | ||
| Z-0849-05 | Edwards LifeStent NT Self-Expanding Stent and Delivery System; Models: NT186901(D)... | Edwards Lifesciences LLC | MAF | ||
| Z-0874-05 | Nichols Advantage TSH - Third Generation | Nichols Institute Diagnostics | JLW | ||
| Z-0806-05 | Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery... | MRL, Inc., A Welch Allyn Company | MKJ | ||
| Z-1526-05 | Electrophysiology Imaging System | Fischer Imaging Corp. | JAA | ||
| Z-1525-05 | Electrophysiology Imaging System | Fischer Imaging Corp. | JAA | ||
| Z-1524-05 | Electrophysiology Imaging System | Fischer Imaging Corp. | JAA | ||
| Z-0162-06 | ''Fine Tuning Your Pump'' booklet provided with Model MMT-515 AND MMT-715 INSULIN... | Medtronic, Inc. | LZG | ||
| Z-0932-05 | Tyco Healthcare Kendall Argyle Neonatal Pediatric PICC, 1.9 Fr/Ch x 30 cm Dual Lumen PICC... | Medtronic, Inc. | LJS | ||
| Z-1381-05 | Hemochron Jr. Whole Blood Microcoagulation system Low Range Activated Clotting Time... | Accriva Diagnostics, Inc. | JBP | ||
| Z-0853-06 | Affymetrix GeneChip Microarray Instrumentation System, consisting of GeneChip 3000Dx... | Affymetrix Inc | NSU | ||
| Z-0930-05 | Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5mm... | Abbott Medical | JOH | ||
| Z-1047-05 | Ohmeda Medical''s Giraffe OmniBeds and Giraffe Incubators | GE Healthcare | FMZ | ||
| Z-1223-06 | IBC FloProbe (Non-sterile), a disposable flow probe that is used as a component of the... | International Biophysics Corp. | DPT | ||
| Z-1044-05 | Nichols Advantage ACTH Test System, catalog number 62-7004. | Nichols Institute Diagnostics | CKG | ||
| Z-0994-05 | IMMULITE 2000. An Automated, Quantitative Immunoassay Analyzer for In Vitro Diagnostic... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-0820-05 | Moi-Stir oral swabsticks, an aid to mouth care and oral hygiene, CONTENTS: 3... | Kingswood Laboratories, Inc. | LFD | ||
| Z-0847-05 | Fresh Look * Radiance * Moonlight, (phemfilcon) Contact Lenses * -2.75 median, Median... | Alcon Laboratories | LPL | ||
| Z-0943-05 | Baxter Interlink System Continu-Flo Solution Set with Large Bore 4-Way Stopcock Extension... | Baxter Healthcare Corporation | FMG | ||
| Z-1085-05 | Puritan Bennett 840 Series Ventilator Power Supply Model/Catalog Numbers: 4-076314-00... | Medtronic, Inc. | CBK | ||
| Z-0338-06 | Bivona brand Cuffless Extra Length Fixed Hyperflex Adult Tracheostomy Tube, 110 mm... | Abbott Medical | BTO | ||
| Z-1075-05 | BD #11 Bard Parker Scalpel. A general use surgical blade, frequently used for ''stab... | Becton Dickinson & Co | GES | ||
| Z-0931-05 | PTFE (Polytetrafluoroethylene) felt. Catalog #s: M002000193041, M002000193061... | Boston Scientific Corporation | DXZ | ||
| Z-0415-06 | GE Millennium Systems: MPR and MPS Digital CSE Single Detector Gamma Camera. This... | GE Healthcare | KPS | ||
| Z-0414-06 | GE Millennium Systems: MG. Multi-Geometry Digital CSE Dual Detector Gamma Camera. A... | GE Healthcare | KPS | ||
| Z-0413-06 | GE Millennium Systems: MC, MyoSight. Dual Head Gamma Camera. A compact... | GE Healthcare | KPS | ||
| Z-0866-05 | VITROS VALP Reagent , REF 680 1710. Each box contains 6 packs. Each pack contains... | Ortho-Clinical Diagnostics, Inc. | LEG | ||
| Z-0883-05 | Roche brand AccuData GTS/GTS Plus System Replacement Base/Module; Catalog number 3426050... | Roche Diagnostics GmbH | CGA | ||
| Z-0882-05 | Roche brand AccuData GTS System; Catalog number 404, material number 03136833001. | Roche Diagnostics GmbH | CGA | ||
| Z-0881-05 | Roche brand AccuData GTS Plus System; Catalog number 3000249, material number 03000249001. | Roche Diagnostics GmbH | CGA | ||
| Z-1778-2008 | Xcelerate Patella System Reamer Shaft Assembly; Non-Sterile; Howmedica Osteonics... | Howmedica Osteonics Corp | HTO | ||
| Z-0886-05 | 22G Nerve Block PainPak, Reorder No.:3269, kit manufactured by Integra Spinal... | Spinal Specialties, Inc. | CAZ | ||
| Z-0885-05 | Clinical Technologies, Inc., 25 G Spinal Painpak, Reorder No.:4043, kit manufactured by... | Spinal Specialties, Inc. | CAZ | ||
| Z-1066-05 | Zimmer brand Versys Hip System Femoral Head 12/14 taper, 32 mm dia., neck length +0mm... | Zimmer GmbH | JDI | ||
| Z-0921-05 | Flexible Implant tube, blind end, 350 mm, part # GM11003730, labeled in part ***Varian... | Varian Medical Systems, Inc. | JAQ | ||
| Z-0056-06 | Nichols Advantage QuiCk- Intraoperative Bio-Intact PTH Assay, Catalog No. 62-7045. | Nichols Institute Diagnostics | CEW | ||
| Z-1419-05 | PTT-LA. Lupus anticoagulant-sensitive APTT reagent. Diagnostica Stago, 6x 2mL... | Diagnostica Stago, Inc. | GGW | ||
| Z-1162-06 | Leica M520 Surgical Microscope; a surgical microscope with a 6:1 motorized zoom... | Leica Microsystems, Inc. | EPT | ||
| Z-0837-05 | Centurion brand CirClamp with 1.1 cm bell, sterile, single use; product 310. | Centurion Medical Products, LP | HFX | ||
| Z-0811-05 | The Heartport EndoClamp aortic catheter is a 10.5 Fr. wirewound, three-lumen catheter... | Heartport, Inc. | DWZ |