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-0715-2011 | Polaris Spectra System Control Unit, a component of the StealthStation S7 System... | Medtronic Navigation, Inc | HAW | ||
| Z-0801-2011 | Turon Shoulder System Instrumentation, Turon Pegged Glenoid Drill Guide, REF 804-25-024... | Encore Medical, LP | KWS | ||
| Z-0800-2011 | Turon Shoulder System Instrumentation, Turon Trial Pegged Glenoid, DJO Surgical | Encore Medical, LP | KWS | ||
| Z-0799-2011 | Turon Shoulder System Instrumentation, Turon Trial Humeral Neck, DJO Surgical | Encore Medical, LP | KWS | ||
| Z-0798-2011 | Turon Shoulder System Instrumentation, Turon Humeral Head Trials, DJO Surgical | Encore Medical, LP | KWS | ||
| Z-2687-2011 | The product is the "FASTx Sternal Intraosseous Device". The expiration date for the... | Pyng Medical Corp. | FMI | ||
| Z-1369-2011 | Allura XPER FD 20 and and Allura CV20; Allura XPER FD 10 and Field Extension for XPER... | Philips North America LLC | IZI | ||
| Z-0615-2011 | Incorrect Label: Endocare 2.4mm VARIABLE ATTACHED CRYOPROBE, REF: CVA 2400, LOT 2751... | Varian Medical Systems, Inc. | GEH | ||
| Z-1368-2011 | Allura XPER FD 10 and Field Extension for XPER Cardiovascular System and Allura XPER FD... | Philips North America LLC | IZI | ||
| Z-1146-2012 | Correct VPS Vinyl Polysilocane Impression Material, Product Number Q01B. The intended use... | Sybron Dental Specialties, Inc. | ELW | ||
| Z-0345-2012 | Odyssey A radiation treatment planning system | Optivus Proton Therapy, Inc. | MUJ | ||
| Z-2644-2011 | ONCOR Impression Plus, camera imaging system, Part Number: 5857912, Product is... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-2643-2011 | ONCOR Impression, camera imaging system, Part Number: 5857920; Product is manufactured... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-2642-2011 | ONCOR Avant Garde , camera imaging system, Part Number:5863472; Product is manufactured... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-2641-2011 | PRIMUS HI, camera imaging system, Part Number: 4504200; Product is manufactured and... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-2640-2011 | MEV ATRON M2/PRIMUS MID-ENERGY, camera imaging system, Part Number: 1940035; Product is... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-2639-2011 | MEV ATRON PRIMART, camera imaging system, Part Number: 5500371; Product is manufactured... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-2638-2011 | MEVATRONKD-2, camera imaging system, Part Number: 8515520; Product is manufactured and... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-2637-2011 | MEVATRONKD, camera imaging system, Part Number: 8319857; Product is manufactured and... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-2636-2011 | Mevatron K2, camera imaging system, Part Number: 1940753; Product is manufactured and... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-2635-2011 | BEAMVIEW IT, camera imaging system, Part Number: 5410389 & 5852301; Product is... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0445-2011 | Lumen Biomedical Xtract Aspiration Catheter system, intravascular catheter, consisting... | Volcano Corporation | OGX | ||
| Z-0563-2011 | Sarns 8000 Roller pump for Sarns System 8000 Heart Lung Machine console, 220V, Catalog No... | Terumo Cardiovascular Systems Corporation | JOR | ||
| Z-0562-2011 | Sarns 8000 Roller pump for Sarns System 8000 Heart Lung Machine console, 115V, Catalog No... | Terumo Cardiovascular Systems Corporation | JOR | ||
| Z-1246-2011 | ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-327 (NF DB UR 6... | Ortho Organizers Inc | DZD | ||
| Z-1587-2011 | PolyAx Locking Plate System, POLYAX FEMORAL PLATE - RIGHT, 9 hole, Sterile, REF... | Depuy Orthopaedics Inc. | HRS | ||
| Z-1586-2011 | PolyAx Locking Plate System, POLYAX FEMORAL PLATE - LEFT, 18 hole, Sterile, REF... | Depuy Orthopaedics Inc. | HRS | ||
| Z-1585-2011 | POLYAX FEMORAL PLATE - LEFT, 15 hole, Sterile, REF 8141-31-115, Depuy Orthopaedics, Inc... | Depuy Orthopaedics Inc. | HRS | ||
| Z-1584-2011 | PolyAx Locking Plate System, POLYAX FEMORAL PLATE - LEFT, 12 hole, Sterile, REF... | Depuy Orthopaedics Inc. | HRS | ||
| Z-1583-2011 | PolyAx Locking Plate System, POLYAX FEMORAL PLATE - LEFT, 9 hole, Sterile, REF... | Depuy Orthopaedics Inc. | HRS | ||
| Z-1582-2011 | PolyAx Locking Plate System, POLYAX FEMORAL PLATE - LEFT, 6 hole, Sterile, REF... | Depuy Orthopaedics Inc. | HRS | ||
| Z-1581-2011 | PolyAx Locking Plate System, POLYAX FEMORAL PLATE - RIGHT, 18 hole, Sterile, REF... | Depuy Orthopaedics Inc. | HRS | ||
| Z-1580-2011 | PolyAx Locking Plate System, POLYAX FEMORAL PLATE - RIGHT, 15 hole, Sterile, REF... | Depuy Orthopaedics Inc. | HRS | ||
| Z-1579-2011 | PolyAx Locking Plate System, POLYAX FEMORAL PLATE - RIGHT, 12 hole, Sterile, REF... | Depuy Orthopaedics Inc. | HRS | ||
| Z-1578-2011 | PolyAx Locking Plate System, POLYAX FEMORAL PLATE - RIGHT, 6 hole, Sterile, REF... | Depuy Orthopaedics Inc. | HRS | ||
| Z-0815-2011 | CuttingEdge Advantage Rasp Handle, Straight Rasp Handle, & Specialty Head Center Accolade... | Howmedica Osteonics Corp | LXH | ||
| Z-1011-2011 | ABL90 FLEX Blood Analyzer Part Number: 393-090. Intended for use by trained... | Radiometer America, Inc | CEM | ||
| Z-2189-2011 | CDI Blood Parameter Monitoring System 500 with Venous Blood parameter module Catalog... | Terumo Cardiovascular Systems Corporation | DRY | ||
| Z-2188-2011 | CDI Blood Parameter Monitoring System 500 with Arterial Blood parameter module Catalog... | Terumo Cardiovascular Systems Corporation | DRY | ||
| Z-2187-2011 | CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter... | Terumo Cardiovascular Systems Corporation | DRY | ||
| Z-2186-2011 | CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module and... | Terumo Cardiovascular Systems Corporation | DRY | ||
| Z-2185-2011 | CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter... | Terumo Cardiovascular Systems Corporation | DRY | ||
| Z-1944-2011 | Terumo Cardiovascular Systems Corporations, CDI 100 Hematocrit/ Oxygen Saturation... | Terumo Cardiovascular Systems Corporation | DTY | ||
| Z-1943-2011 | Terumo Cardiovascular Systems Corporations, CDI 101 Hematocrit/Oxygen Saturation... | Terumo Cardiovascular Systems Corporation | DTY | ||
| Z-0601-2011 | Medefil Heparin I.V. Flush Syringe 1 units/mL; a polypropylene luer locking syringe... | Medefil, Inc. | NZW | ||
| Z-0600-2011 | Medefil Heparin I.V. Flush Syringe 10 units/mL; a polypropylene luer locking syringe... | Medefil, Inc. | NZW | ||
| Z-0599-2011 | Medefil Heparin I.V. Flush Syringe 100 units/mL; a polypropylene luer locking syringe... | Medefil, Inc. | NZW | ||
| Z-2265-2012 | Class II | Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, Models... | Canon Inc. | MQB | |
| Z-0802-2013 | Class II | Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen... | Terumo Cardiovascular Systems Corporation | DRY | |
| Z-0932-2012 | Solanas Posterior Stabilization System Part Number: 63920. Solanas Posterior... | Alphatec Spine, Inc. | KWP |