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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.

FlexTray Procedure Delivery System Endopath General Laparoscopic Tray, Product #TGL56.

FDA Recall
Terminated ·Ethicon Endo-Surgery·Product code LFL·November 25, 2003

Ethicon Endo-Surgery Endopath ETS-Flex Articulating Endoscopic Linear Cutter, 35mm Standard, Product #ATB35.

FDA Recall
Terminated ·Ethicon Endo-Surgery·Product code GDW·November 25, 2003

Solar 9500 Information Monitor with software version 3A.

FDA Recall
Terminated ·General Electric Medical Systems Information Technology·Product code MHX·November 10, 2003

FlexTray Procedure Delivery System Endopath Bariatric Surgery Tray, Product #KNB21.

FDA Recall
Terminated ·Ethicon Endo-Surgery·Product code GCJ·November 25, 2003

Stryker brand Firstcare Ultra Maternity bed and Stryker brand Adel Maternity bed, 220 volt, model 5012, with night light.

FDA Recall
Terminated ·Stryker Medical·Product code HDD·January 26, 2004

LAERDAL Silicone Resuscitator (LSR), Adult size, containing Intake/Reservoir Valve. Sold as Part Nos: 870050-Adult Basic w/o Mask in Carton; 870051-Adult Complete in Carton; 870052-Adult Standard with Adult Mask 4-5+ in Carton; 870053-Adult Complete in Compact Case; 870055-Adult Complete in Display Case; 875500-Adult Update Kit. Responsible firm on the label: Distributed in the U.S. by Laerdal Medical Corporation, Wappingers Falls, NY, Made in Norway.

FDA Recall
Terminated ·Laerdal Medical Corporation·Product code BTM·December 23, 2003

LAERDAL Silicone Resuscitator (LSR), Preterm Size, containing an Intake/Reservoir Valve. Sold as Part Nos: 850050-Preterm Basic w/o Mask in Carton; 850051-Preterm Complete in Carton; 850053-Preterm Complete in Compact Case; 850055-Preterm Complete in Display Case; 855500-Preterm Update Kit. Responsible firm on the label: Distributed in the U.S. by Laerdal Medical Corporation, Wappingers Falls, NY, Made in Norway.

FDA Recall
Terminated ·Laerdal Medical Corporation·Product code BTM·December 23, 2003

Esaote brand Formul@ ECG System; part 9704220000.

FDA Recall
Terminated ·Esaote Biomedica S.P.A. c/o The Anson Group·Product code DPS·December 23, 2003

Pulsox-3iA. LCD, Sp02, PR, Pulse strength bar, motion artifact, low battery message, error message, low Sp02 message, event mark. Measuring range Sp02 0 to 100, pulse rate 20 to 250, measuring accuracy Sp02 +/-2% (70 to 100), pulse rate +/- 2, Sp02 alarm, audible and visible, probe type finger, multi-site, paitent range adult to neonatal, memory function approx. 24 hrs, printer/recorder optional accessory, output RS232 w/optional interface module, power supply 2 AAA batteries, Battery life approx. 48 hrs, size 42x68x20mm, weight 42g.

FDA Recall
Terminated ·Minolta Corp·Product code DQA·November 14, 2003

ADx Tricyclic Antidepressants Reagent. Distributed under the following label: ADx Tricyclic Antidepressants Reagents, Abbott Laboratories USA, North Chicago, IL 60064

FDA Recall
Terminated ·Abbott Health Products, Inc.·Product code LFH·November 17, 2003