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-0075-04 | Belos VR-T Implantable Cardioverter Defibrillator | BIOTRONIK AG | LWS | ||
| Z-0074-04 | Belos VR Implantable Cardioverter Defibrillator | BIOTRONIK AG | LWS | ||
| Z-0073-04 | Belos DR-T Implantable Cardioverter Defibrillator | BIOTRONIK AG | LWS | ||
| Z-0072-04 | Belos DR Implantable Cardioverter Defibrillator | BIOTRONIK AG | LWS | ||
| Z-0098-04 | Bard -Winged Infusion Set with Injection Site. Sterile, Non-Pyrogenic. | Bard Access Systems, Inc. | FMI | ||
| Z-0062-04 | Premier Toxins A & B, Diagnostic Test Kits, Catalog No. 616096. | Meridian Bioscience Inc | LLH | ||
| Z-0044-04 | Pin Driver Coupler, component of MicroAire Drill\Reamer Model 7500. Driver couplers are... | MicroAire Surgical Instruments, LLC | |||
| Z-0043-04 | Wire Driver Coupler, Model 7100-045, a component of MicroAire Drill/Reamer Model 7500... | MicroAire Surgical Instruments, LLC | |||
| Z-0061-04 | Stat Profile Critical Care Expres Ionized Magnesium Sensor (In-vitro Diagnostic used with... | Nova Biomedical Corporation | CHL | ||
| Z-0060-04 | Stat Profile Ultra Magnesium Sensor (In-vitro Diagnostic used with the Stat Profile Ultra... | Nova Biomedical Corporation | CHL | ||
| Z-0045-04 | LifeSite Hemodialysis Cannula Exchange Kit Part Number: LHCEK0000 | Vasca, Inc. | MSD | ||
| Z-0339-04 | Hip Stem, Sterile Pkg. The implant consists of 2 metal componets which fit together to... | Plus Orthopedics | LWJ | ||
| Z-0090-04 | Device to determine quantitative total testosterone in human serum | Qualigen Inc | CDZ | ||
| Z-0063-04 | IMx Tacrolimus II Calibrators, list 3C10-10; the pack contains six 4.5-mL bottles, with... | Abbott Medical | MLM-- | ||
| Z-0096-04 | Synchron CX Systems version 4.0 Operating Software used in Synchron LX20 Systems... | Siemens Healthcare Diagnostics Inc. | JQP | ||
| Z-0010-04 | Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124 | Bard Peripheral Vascular Inc | DQY | ||
| Z-0008-04 | Rultract Surgical Retractor, 4100 Series, all system configurations, reusable. | Rultract Inc | DWS | ||
| Z-1115-04 | Synchron CX (and) Synchron LX Systems Microalbumin Calibrator. | Siemens Healthcare Diagnostics Inc. | JIS | ||
| Z-0084-04 | Cannon catheter hemodialysis catheterization set, 15 Fr x 36 cm | Arrow International LLC (subsidiary of Teleflex Incorporated) | KZH | ||
| Z-0083-04 | Arrow central venous catheterization kit, 14 ga x 20 cm | Arrow International LLC (subsidiary of Teleflex Incorporated) | KZH | ||
| Z-0082-04 | Arrow Howes multi-lumen central venous catheterization kit 7 Fr x 20 cm | Arrow International LLC (subsidiary of Teleflex Incorporated) | KZH | ||
| Z-0144-04 | Hyfrecator 20)0 Electrosurgical Unit. Hyfrecator 2000, P/N 7-900-XXX (where XXX may... | ConMed Corporation | GEI | ||
| Z-0095-04 | Philips Odyssey LX Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems. | Philips North America LLC | LLZ | ||
| Z-0094-04 | Philips Odyssey FX Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems. | Philips North America LLC | LLZ | ||
| Z-0093-04 | Philips Odyssey VP Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems. | Philips North America LLC | LLZ | ||
| Z-0042-04 | Guide pin (component of the Tibial Punch Guide) of the Balanced Knee System. | Ortho Development Corp. | JWH | ||
| Z-0050-04 | Channel Neuroendoscope, Standard Resolution, 13 cm, Catalog No. 2232-003. | Medtronic Neurosurgery | GWG | ||
| Z-0049-04 | Channel Neuroendoscope, Standard Resolution, 21.6 cm. Catalog No. 2232-001 | Medtronic Neurosurgery | GWG | ||
| Z-1292-03 | Quantum TTC Biliary Balloon Dilator | Wilson-Cook Medical Inc. | KNQ | ||
| Z-0153-04 | Weber SolarJet S CO2 Vector Laser Coder System; Weber Marking Systems, Inc., Arlington... | Weber Marking System Inc. | LS-99 | ||
| Z-0556-04 | BE 183 Series Manual Jet Ventilators. Manual Jet Ventilator with Regulator and Gauge. | Instrumentation Industries, Incorporated | BTM | ||
| Z-0555-04 | BE 183 Series Manual Jet Ventilators. Manual Jet Ventilator | Instrumentation Industries, Incorporated | BTM | ||
| Z-0006-04 | McGhan Style 40, Round Breast Implant, Standard Projection, Silicone-filled Smooth... | Allergan | FTR | ||
| Z-1293-03 | CoaguChek brand PT Test Strips; U.S. catalog number 3116247 (professional use), 3116239... | Roche Diagnostics GmbH | GJS | ||
| Z-0325-05 | The Is-Syphilis TREP-CHEK (TM) Test Kit is a confirmatory in vitro enzyme immunoassay for... | Diamedix Corp. | LIP | ||
| Z-0572-05 | Varcella Zoster ELISA Kit for the detection of IgG antibodies to varicella zoster virus... | Diasorin Inc. | LFY | ||
| Z-1297-03 | CryoValve, Pulmonary Valve & Conduit | Artivion, Inc. | NJK | ||
| Z-1296-03 | CryoValve, Aortic & Conduit | Artivion, Inc. | MIE | ||
| Z-0038-04 | Sideport Kit w/Oxygen Line, consisting of an adjustable sideport valve, an O2 port elbow... | Halyard Health | CAI | ||
| Z-0037-04 | Sideport Kit, consisting of an adjustable sideport valve and an O2 port elbow; Mfg. for... | Halyard Health | CAI | ||
| Z-0036-04 | Hyperinflation Circuit, consisting of a 2.0 L breathing bag, pressure monitoring tube... | Halyard Health | CAI | ||
| Z-0035-04 | Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure... | Halyard Health | CAI | ||
| Z-0034-04 | Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure... | Halyard Health | CAI | ||
| Z-0033-04 | Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure... | Halyard Health | CAI | ||
| Z-0161-04 | Reusable Catheter Passer (60 cm) SP02. One stainless steel catheter passer with T handle. | Phoenix Biomedical Corp. | FOZ | ||
| Z-0169-04 | Ambulatory infusion pump. Model 511 | Medtronic, Inc. | LZG | ||
| Z-0160-04 | Reusable Catheter Passer (40 cm) SP01. One stainless steel catheter passer with T handle. | Phoenix Biomedical Corp. | FOZ | ||
| Z-0040-04 | Coulter AcT 5diff Cap Pierce Hematology Analyzers Part Numbers: 6605641, 6605705 | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-0039-04 | Coulter AcT 5diff Open Vial Hematology Analyzers Part Numbers: 6605580, 6605581, 6605604 | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-0029-04 | Dow Corning Silastic brand Medical Adhesive Silicone, Type A, non-sterile, 57 gram tube... | Dow Corning Corp. |