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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.

Ultracell Ear Wick Fenestrated 9mm DIA x 15mm Catalog #: 30305-C

FDA Recall
Terminated ·Ultracell Medical Technologies·Product code KCN·January 8, 2003

Haemonetics Cell Saver 5 Low Volume (12ml) Fast Pack with Filtered Reservoir List Number: 265F

FDA Recall
Terminated ·Haemonetics Corporation·Product code CAC·December 17, 2002

Misys Laboratory version 5.3

FDA Recall
Terminated ·Sunquest Information Systems·Product code JQP·November 15, 2002

Simplasitin Excel, 10 x 6ml, 25200, For Prothrombin Time determinations, bioMerieux, Inc. Durham, NC 27704. The product consists of two vials, a thromboplastin reagent and a diluent ( the vials are mixed together before use).

FDA Recall
Terminated ·Biomerieux, Inc.·Product code GJS·February 4, 2003

HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, T5C8300R

FDA Recall
Terminated ·Baxter Healthcare Corp. Rt·Product code FKX·December 23, 2002

''ComforTEC II Single Use pH Probe *** Latex Free *** Do Not Re-use''. Packaged individually.

FDA Recall
Terminated ·Sandhill Scientific, Inc·Product code FFT·January 8, 2003

PO2 electrode for Roche AVL OMNI Analyzers. Catalog number BP1734.

FDA Recall
Terminated ·Roche Diagnostics Corp.·December 16, 2002

CA 15-3 Calibrators, list 9C08-01; the pack contains six 4-mL bottles of 115D8:DF3 reactive determinants prediluted in TRIS buffer with protein stabilizers to yield the following assay values: A - 0 u/mL, B - 15 U/mL, C - 60 U/mL, D - 120 U/mL, E - 180 U/mL and F - 250 U/mL; Abbott Laboratories, Abbott Park, IL 60064

FDA Recall
Terminated ·Abbott Laboratories HPD/ADD·Product code MOI·March 4, 2003

Compat 500 mL Baggle Top Fill Enteral Feeding Container with Preattached Enteral Delivery Pump Set, Item number 19931200

FDA Recall
Terminated ·Novartis Nutrition Corp·Product code LZH·January 27, 2003

VAMP Direct Draw, Model VMP700 Needleless cannula for sampling blood.

FDA Recall
Terminated ·Edwards Lifesciences AG Parque Industrial Itabo Km. 18.5 Carr. Sanchez Haina, San Cristobal Dominican Republic·Product code KRA·November 20, 2003