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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.

Salmonella typhi IgG/IgM Duo Test; LumiQuick. Santa Clara, CA 95054

FDA Recall
Terminated ·LumiQuick Diagnostics Inc.·March 4, 2014

Fecal Occult Blood Test Strip; LumiQuick. Santa Clara, CA 95054

FDA Recall
Terminated ·LumiQuick Diagnostics Inc.·March 4, 2014

Morphine Test Card (2000); LumiQuick, Santa Clara, CA 95054

FDA Recall
Terminated ·LumiQuick Diagnostics Inc.·March 4, 2014

Alcohol Test, Saliva; LumiQuick. Santa Clara, CA 95054

FDA Recall
Terminated ·LumiQuick Diagnostics Inc.·March 4, 2014

Troponin I test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054

FDA Recall
Terminated ·LumiQuick Diagnostics Inc.·March 4, 2014

Rotavirus Test Card LumiQuick, Santa Clara, CA 95054

FDA Recall
Terminated ·LumiQuick Diagnostics Inc.·March 4, 2014

Methadone Test Strip; LumiQuick,. Santa Clara, CA 95054

FDA Recall
Terminated ·LumiQuick Diagnostics Inc.·March 4, 2014

1) Nephros SafeShower FH - 15 filters per box; item no. 70-0236 2) Nephros SafeShower HH -6 filters per box ; item no. 10-0237 Manufactured by : Nephros, Inc. 41 Grand Ave, River Edge, NJ 07661 Assembled at MEDICA 41036 Medolla, Italy The Nephros SafeSpout and SafeShower are intended to filter water for washing and drinking. They are intended to be installed at the end of a standard sink faucet or shower hose

FDA Recall
Terminated ·Nephros Inc·Product code ND·October 28, 2013

ABACUS TPN Calculation Software, Baxa: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition) ABACUS is a Windows - based order entry TPN software application for comprehensive calculations and label printing. The primary use of Abacus is for TPN order calculations. Other uses of Abacus include: non-TPN volumes administered to patients on TPN therapy in order calculations; CVVH calculations; Cardioplegia (Buckburg) calculations; Epidural calculations; Dilutions from concentrated ingredient; Combinations of multiple ingredients; Fractional doses from larger volumes

FDA Recall
Terminated ·Baxter Corporation Englewood·Product code LNX·December 3, 2013

chromID Salmonella Agar, Reference No. 43621. A selective isolation and differentiation medium for the detection of Salmonella in human specimens.

FDA Recall
Terminated ·bioMerieux, Inc.·September 6, 2013