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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.

G1725: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device and 1 mL Line Draw Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.

FDA Recall
Terminated ·Smiths Medical ASD, Inc.·Product code JKA·November 22, 2013

Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106.

FDA Recall
Terminated ·Mar Cor Purification·Product code FIP·June 27, 2012

K-Lite Knee 2 Stays with Visco, Model No. 122015. Product Usage: The product is intended to provide flexible knee support.

FDA Recall
Terminated ·Breg Inc·Product code IQI·March 14, 2014

19FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage

FDA Recall
Terminated ·Aspen Surgical Products, Inc.·Product code GCY·March 20, 2014

Smiths Medical HOTLINE Fluid Warming Set L-80. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions

FDA Recall
Terminated ·Smiths Medical ASD, Inc.·Product code LGZ·March 17, 2014

Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer intended for the in vitro quantitative / qualitative determination of analytes in body fluids.

FDA Recall
Terminated ·Roche Diagnostics Operations, Inc.·Product code JJE·March 13, 2014

19FR Drain Kit Flat Full Perforated with Trocar, Saber 100ml Bulb and 3CSystem, Sterile (10/case) Intended for closed wound suction drainage

FDA Recall
Terminated ·Aspen Surgical Products, Inc.·Product code GCY·March 20, 2014

10mm Drain Kit Flat 3/4 Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage

FDA Recall
Terminated ·Aspen Surgical Products, Inc.·Product code GCY·March 20, 2014

Sutures, Non-absorbable, Synthetic, Polypropylene, Sterile, Rx only, Product Usage: Non-absorbable polypropylene surgical suture is a monofilament, Non-absorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation.

FDA Recall
Terminated ·Teleflex Medical·Product code GAT·March 11, 2014

Weck Vista" Universal Laparoscopic Port, Size 5/10/12mmx125mm, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.

FDA Recall
Terminated ·Teleflex Medical·Product code GCJ·March 11, 2014