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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.

96-8366 Drip Chambers, Convertible with Pierce Pin .138 Assembly; Abbott, Ashland, Ohio 44805; 650 drip chambers per case; Abbott Commodity 968366, Ashland Product #85-55960

FDA Recall
Terminated ·Abbott Laboratories HPD/ADD·Product code FPA·June 9, 2003

I.V. Pump Sets with Cassettes for use with Abbott Plum Series and Lifecare Infusion Pumps; sterile, Rx, single use devices; Abbott Laboratories, North Chicago, IL 60064 USA; 86 different sets listed in the code information section below.

FDA Recall
Terminated ·Abbott Laboratories HPD/ADD·Product code FRN·June 9, 2003

Stryker Secure II hospital bed; model 3002.

FDA Recall
Terminated ·Stryker Medical·Product code FNL·May 1, 2003

Rejuv O2 Home Oxygen Spa 98% + Pure, Non-pressurized Oxygen for Breathing. Benefits of Oxygen Therapy May Include: Increased Energy, Increased Mental Alertness, Increased Concentration and Memory, Increased Stamina, Improved Sleep, Relief of Stress and Anxiety. Portable Oxygen Delivery System: 98%+ pure humidified oxygen. Safe, transportable and non-pressurized. Over one hour total humidified oxygen. Over 5 liters per minute volumetric humidified flow rate. Lightweight and easily portable. Reusable system. Environmentally acceptable. Refill packs available. Maintenance free. Refill powders have a 2 year shelf life. Box Includes Reusable reaction chamber with dome assembly. 4 White Powder refills. 4 Black Powder refills. Reusable water bottle. Nasal cannula. Medium concentration mask. Canvas Carry Bag. Operating Instructions xxx, Directions: xxx, Caution: xxx, Applications: This system is designed expressly for cosmetic and nutraceutical applications. Manufactured by Oxygen Delivery Systems, LLC, 490 Mathis Airport Road, Suwanee, GA 30024.

FDA Recall
Terminated ·System 02 Inc 1090 Upper Hembree Rd Roswell GA 300761140·Product code CAW·May 1, 2003

StatLock Tandem Microbore Catheter Extension Set with preattached Clearlink Valve 6'' LL. Model number 2N9205K.

FDA Recall
Terminated ·Venetec Intl Inc·Product code FPA·May 12, 2003

Mitek M. Kurosaka Advantage 7 X 30 mm Cannulated Fixation Screw Product Reference No.: 230030

FDA Recall
Terminated ·Mitek Worldwide·Product code HWC·February 28, 2003

Heat Exchanger Coil (code Number 0006-0011) used in the ''Custom Cardiovascular Procedure Kits'' .

FDA Recall
Terminated ·Terumo Cardiovascular Systems Corp·Product code DTR·November 7, 2002

Tachos DR - Implantable Cardioverter Defibrillator.

FDA Recall
Terminated ·Biotronik Inc·Product code LWS·February 21, 2003

AngioDynamics 15F EmboSafe Valved Peelable Introducer, 5 units per shelf box, Catalog number 06507602

FDA Recall
Terminated ·MedAmicus, Inc·Product code DYB·June 6, 2003

Cobe Cardiovascular BCD Vanguard Cardioplegia Delivery System, 8:1 with Shunt.

FDA Recall
Terminated ·Cobe Cardiovascular, Inc·Product code DTN·May 9, 2003