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-1647-2010 | Bard Mesh Monofilament Knitted Polypropylene; Contents: size 2" x 4", 3 units per box... | Ram Medical Inc | FTL | ||
| Z-1426-2010 | REF 822 IMUBIND(R) Plasma PAI-1 ELISA The intended use: Product is an enzyme-linked... | Sekisui Diagnostics, LLC | GGP | ||
| Z-1313-2010 | Datascope AS3000 Anesthesia System; Mindray, North America. The AS3000 Anesthesia... | Datascope Corp. | BSZ | ||
| Z-0448-2011 | Access Immunoassay Systems Estradiol, Part Number: 33540 Intended use: The Access... | Siemens Healthcare Diagnostics Inc. | CHP | ||
| Z-0107-2011 | Active I-PTH Enzyme-Linked Immunosorbent Assay(ELISA), Part Number: DSL-10-8000 The... | Siemens Healthcare Diagnostics Inc. | CEW | ||
| Z-1237-2010 | Axiom Artis Systems operating with A100 Generator | Siemens Medical Solutions USA, Inc. | MQB | ||
| Z-1410-2010 | Biphasic LIFEPAK 15 Monitor/Defibrillator. Manufactured by Physio-Control Inc., a... | Physio Control, Inc. | MKJ | ||
| Z-1317-2010 | HeartStart MRx Defibrillator Monitor (Models M3535A, M3536A and M3536J) used with Philips... | Philips North America LLC | MKJ | ||
| Z-1321-2010 | Agendia MammaPrint, Catalog Numbers MP01, MP US version 03 | Agendia Inc | NYI | ||
| Z-1310-2010 | Aplicare Advantage Dressing Change System, Central Line Dressing Change, Sterile Part... | Aplicare, Inc. | NAD | ||
| Z-1648-2011 | Bio Rad brand Autoimmune EIA Anti-dsDNA Test Kit, 576 Tests, Catalog No. 576DS... | Bio-Rad Laboratories Inc. | LRM | ||
| Z-1647-2011 | Bio Rad brand Autoimmune EIA Anti-dsDNA Test Kit, 96 Tests, Catalog No. 96DS, Distributed... | Bio-Rad Laboratories Inc. | LRM | ||
| Z-1656-2010 | UniCel DxH 800 Coulter Cellular Analysis System, Part Number 629029. Beckman Coulter... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-1443-2010 | Literature for Implant Extraction Set - Implant Extraction Guide Module One & Two. Lists... | Howmedica Osteonics Corp | HWB | ||
| Z-0916-2012 | Drystar Mammo. Display of Mammographic images. | AGFA Healthcare Corp. | IWZ | ||
| Z-2296-2010 | V. Mueller Peanut Sponges, Catalog number 23275-470, Sterile, For Single Use Only, Size... | He, Inc | GDI | ||
| Z-1479-2011 | Bio Rad brand Autoimmune EIA ANA Screening Kit, 96 Tests, Catalog No. 96AN-BPU-TRINITY... | Bio-Rad Laboratories Inc. | LKJ | ||
| Z-0540-2011 | Autoimmune EIA ANA Screening Test Kit, 576 Tests, Model/Catalog Number: 576AN... | Bio-Rad Laboratories Inc. | LKJ | ||
| Z-0539-2011 | Autoimmune EIA ANA Screening Test Kit, 96 Tests, Model/Catalog Number: 96AN manufactured... | Bio-Rad Laboratories Inc. | LKJ | ||
| Z-0482-2011 | Neuroform 3 Microdelivery Stent System; Distributed and manufactured by: Boston... | Boston Scientific Corporation | NJE | ||
| Z-0874-2012 | Axium Detachable Coil System QC-7-30-Helix The ev3 Axium Detachable Coil System is... | Medtronic, Inc. | KRD | ||
| Z-0873-2012 | Axium Detachable Coil System QC-2-1-Helix The ev3 Axium Detachable Coil System is... | Medtronic, Inc. | HCG | ||
| Z-1478-2011 | DiaSorin ETI-ANA Screen Kit, 96 Test, Model Number N0093, manufactured by Bio-Rad... | Bio-Rad Laboratories Inc. | LKJ | ||
| Z-0308-2011 | Panta Support Device Panta Arthrodesis Nail Instrumentation Tray One unit per... | Integra LifeSciences Corporation | HSB | ||
| Z-1853-2011 | Acuson Antares Ultrasound Imaging System with software versions 4.0 and 5.0. | Siemens Medical Solutions USA, Inc. | IYN | ||
| Z-1832-2011 | Acuson S2000 Ultrasound System with software and imaging. The Acuson S2000 ultrasound... | Siemens Medical Solutions USA, Inc. | IYN | ||
| Z-0325-2012 | VariSource iX, Software Version 1.1, Part Number AL20020000 VariSource iX... | Varian Medical Systems, Inc. | JAQ | ||
| Z-2343-2010 | Service parts for Crank Screw Assembly (PN1069-042-010S and 1069-042110S) Stryker... | Stryker Medical | FNJ | ||
| Z-0608-2011 | Quest EIA ANA Screen Bulk Kit, model number 96AN-BPU-QUEST. Manufactured by Bio-Rad... | Bio-Rad Laboratories Inc. | LKJ | ||
| Z-2387-2010 | Dimension Vista Chemistry 2 Calibrator, Catalog number KC120. Used to calibrate... | Siemens Healthcare Diagnostics Inc. | JIX | ||
| Z-2342-2010 | Eye surgery stretcher with crank fowler, model 1079 Stryker Medical 3800 E. Centre Ave... | Stryker Medical | FNJ | ||
| Z-2341-2010 | Eye surgery stretcher with crank fowler, model 1069 Stryker Medical 3800 E. Centre Ave... | Stryker Medical | FNJ | ||
| Z-1704-2011 | Stryker Stiletto Electrosurgical Probe (E-Probe); Model number: 0270-070-550... | Stryker Corp. | GEI | ||
| Z-2590-2010 | UniCel DxC 880i, 860i and 600i Systems; Software Part Number: A84500, A86646... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-1549-2010 | 7.5mm Ti Solid Humeral Nail 250 mm Sterile Catalog number 462.725S Synthes Titanium... | Synthes GmbH | JDS | ||
| Z-1548-2010 | 7.5mm Ti Solid Humeral Nail 230 mm Sterile Catalog number 462.723S Synthes Titanium... | Synthes GmbH | JDS | ||
| Z-1200-2010 | Medtronic, Sutureless, unipolar, myocardial, screw-in pacing lead, 5071-15, 5071-25... | Medtronic, Inc. | DTB | ||
| Z-0613-2011 | Bio-Rad brand Meridian ANA Screen ELISA Test Kit, 96 Test, Catalog No. 4884261... | Bio-Rad Laboratories Inc. | LKJ | ||
| Z-1326-2010 | Pelton & Crane Dental Chairs, Spirit 3000 with magnetic headrest, Pelton & Crane... | KaVo Dental Technologies, LLC | KLC | ||
| Z-1325-2010 | Pelton & Crane Dental Chairs, Spirit 2000 with magnetic headrest, Pelton & Crane... | KaVo Dental Technologies, LLC | KLC | ||
| Z-1324-2010 | Pelton & Crane Dental Chairs, Spirit 1800 with magnetic headrest, Pelton & Crane... | KaVo Dental Technologies, LLC | KLC | ||
| Z-1180-2010 | Pelton & Crane Dental Chairs, Spirit 1500 with magnetic headrest, Pelton & Crane... | KaVo Dental Technologies, LLC | KLC | ||
| Z-1179-2010 | Pelton & Crane Dental Chairs, Chairman 5000 with magnetic headrest, Pelton & Crane... | KaVo Dental Technologies, LLC | KLC | ||
| Z-2028-2010 | OneTouch SureStep Pro Test strips, for use with the OneTouch SureStep Pro Blood Glucose... | Lifescan, Inc. | NBW | ||
| Z-2027-2010 | OneTouch SureStep and SureStep Pro Test strips, for use with the OneTouch SureStep Blood... | Lifescan, Inc. | NBW | ||
| Z-0851-2011 | Video Cart, 120 VAC product labeling is as follows: REF, VP8500, QTY1, Video Cart, 120... | Linvatec Corporation | KQM | ||
| Z-0850-2011 | Video Cart Articulating Arm product labeling is as follows: REF, VP6504, QTY1, Video Cart... | Linvatec Corporation | KQM | ||
| Z-0849-2011 | Video Cart Multi-Specialty product labeling is as follows: REF, VP6502, QTY1, Video Cart... | Linvatec Corporation | KQM | ||
| Z-0848-2011 | Video Cart, Premium 120V product labeling is as follows: REF, VP6501, QTY1, Video Cart... | Linvatec Corporation | KQM | ||
| Z-0847-2011 | The Power Cord Reel is labeled as follows: REF, VP6547, QTY1, POWER CORD REEL, Rx... | Linvatec Corporation | KQM |