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FDA Medical Device Recalls

View 10000 FDA Medical Device Recalls on BEUDAMED, the Better Database on Medical Devices. This searchable listing aggregates recall notices issued by the U.S. Food and Drug Administration for devices removed, corrected, or returned due to safety, labeling, or performance concerns. Each record summarizes the recall reason, affected models and lots, recall class, and recommended actions for patients and providers.

Searchable filters help stakeholders identify affected manufacturers, device models, and recall classes (Class I–III) and review timelines and remediation steps. Healthcare providers and purchasers can use these records to verify whether inventory is affected and to implement recommended corrections, returns, or patient notifications.

GE Healthcare Signa Ovation 0.35T, Model Numbers: Ovation 1-3 (2276937), Ovation 4 (2377062-2, 2377062-5, 2377062-8, or 5118172), and Ovation 5 (5148725). The 0.35T Signa Ovation with Excite Magnetic Resonance system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The 0.35T Signa Ovation with Excite Magnetic Resonance system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the body including, but not limited to, the musculoskeletal, vascular, cardiac, and neuron systems.

FDA Recall
Terminated ·GE Medical Systems, LLC·Product code LNH·November 3, 2008

AMPLILINK Software, version 3.1.0 to 3.2.2 with COBAS AmpliPrep. Catalog number 03563383001, catalog number 04855094001, catalog number 04807197001, catalog number 04862392001, catalog number 05093236001, and catalog number 05201357001. Automated sample preparation for nucleic acid analysis on either the COBAS TaqMan or COBAS TaqMan 48. COBAS AmpliPrep/COBAS TaqMan is capable of tunning HBV, HCV, and HIV tests.

FDA Recall
Terminated ·Roche Molecular Systems, Inc.·Product code JJH·June 2, 2009

Heater Elements for Resuscitaire Infant Radiant Warmers model numbers RW82, RW82 VHA, WBR82, and WMRW82, 120 volt configuration only.

FDA Recall
Terminated ·Draeger Medical Systems, Inc.·Product code FMT·July 29, 2009

Stryker PainPump2 ExFen 5, 5" extended fenestration catheter set for PainPump2, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-500.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FRN·June 16, 2009

GE Datex-Ohmeda ADU Carestation Intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients.

FDA Recall
Terminated ·GE Healthcare·Product code BSZ·October 30, 2008

Dimension Cardiac Troponin I Flex reagent cartridge (CTNI). The CTNI method for the Dimension Clinical Chemistry System with the heterogeneous immunoassay module is an in vitro diagnostic test intended to quantitatively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction and in the risk of stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code MMI·April 8, 2008

Flexicair MC3 (model M4000) Low Airloss Therapy Units, for the prevention of pressure sores.

FDA Recall
Terminated ·Hill-Rom Manufacturing, Inc.·Product code IOQ·May 12, 2009

ABC PROBE REF 160655 5 mm Footswitching Probe, QTY: 1 STERILE CONMED CORPORATION 525 French Rd, Utica, NY 13501 ASSEMBLED IN MEXICO ABC PROBE REF 160655 5 mm Footswitching Probe, QTY: 10 STERILE CONMED CORPORATION 525 FRENCH RD UTICA, NY 13205 ASSEMBLED IN MEXICO Usage: Electrosurgical handpiece for use as monopolar electrosurgical accessory in conjunction with CONMED electrosurgical units equipped with argon beam coagulation.

FDA Recall
Terminated ·ConMed Electrosurgery·Product code GEI·December 18, 2008

HeartStart MRx Defibrillator/Monitor with Q-CPR Meter option.The HeartStart MRx monitor/defibrillator has an option (Q-CPR Meter) to provide visual and audible feedback to the rescuer on the quality of CPR. The Q-CPR option offers real time measurement and corrective feedback on the rate, depth and complete release of compressions, ventilations rate and lack of CPR activity in accordance with current CPR guidelines. The Q-CPR option is contraindicated as follows: *The Q-CPR option is contraindicated for use on neonatal and pediatric patients (under 8 years of age or weighing less than 25 kg). *The Q-CPR option is not for use when CPR is contraindicated.

FDA Recall
Terminated ·Philips Healthcare Inc.·Product code MKJ·May 6, 2010

ABC Bend-A-Beam Handpiece REF 134006 Handcontrol Malleable Handpiece, 6" (15.2 cm) QTY: 1 STERILE CONMED CORPORATION 525 FRENCH RD UTICA, NY 13205 ASSEMBLED IN MEXICO (Pouch label) ABC Bend-A-Beam Handpiece REF 134006 Handcontrol Malleable Handpiece, 6" (15.2 cm) QTY: 10 STERILE CONMED CORPORATION 525 FRENCH RD UTICA, NY 13205 ASSEMBLED IN MEXICO (case label) Usage: Electrosurgical handpiece for use as monopolar electrosurgical accessory in conjunction with CONMED electrosurgical units equipped with argon beam coagulation.

FDA Recall
Terminated ·ConMed Electrosurgery·Product code GEI·December 18, 2008