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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.

400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16TSD

FDA Recall
Terminated ·COVIDIEN LLC·Product code KOD·July 11, 2018

NTEGRIS Allura 9 0 FDXD, System Code 722498 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions

FDA Recall
Terminated ·Philips Electronics North America Corporation·Product code IZI·July 16, 2018

Temperature sensor Foley catheter 8FR, Catalogue Number 102205100880AB Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

FDA Recall
Terminated ·Degania Silicone, Ltd. Degania Bet Dganya Bet Israel·Product code EZL·June 21, 2018

Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388

FDA Recall
Terminated ·Invivo Corporation·Product code MWI·August 3, 2018

INTEGRIS Allura 15-12 (biplane), System Code 722044 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions

FDA Recall
Terminated ·Philips Electronics North America Corporation·Product code IZI·July 16, 2018

5.5 Fr x 40 cm double-lumen PICC Kit, Product Code CDC-44052-VPS2

FDA Recall
Terminated ·Arrow International Inc·Product code LJS·July 17, 2018

Allura Xper F010 DR Table, System Code 722014 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions

FDA Recall
Terminated ·Philips Electronics North America Corporation·Product code OWB·July 16, 2018

Allura Xper FD2O Biplane, System Code 722013 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions

FDA Recall
Terminated ·Philips Electronics North America Corporation·Product code IZI·July 16, 2018

INTEGRIS SUITE, System Code 722199 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions

FDA Recall
Terminated ·Philips Electronics North America Corporation·Product code IZI·July 16, 2018

Disposable Insulin Syringe 0.3mL in 3 different sizes 29Gx1/2, 30Gx5/16, and 31G x 5/16. (10 syringes are packaged in a flexible plastic (poly bag) and 10 flexible plastic (poly bag) are packaged in one in box. Finally, pack the inboxes in the carton case.)

FDA Recall
Terminated ·ShinChang Medical Co., Ltd. 144 1gongdan-Ro Gumi Korea (the Republic of)·Product code FMF·August 24, 2018