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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.

MindFrame Capture LP Revascularization Devices: Product Numbers: (a) REF 300010 (b) REF 300011 (c) REF 300012 (d) REF 300013 (e) REF 300014 (f) REF 300015 (g) REF 300016 (h) REF 300017 (i) REF 300018 Intended to restore blood flow by removing thrombus from a large intracranial vessel experiencing ischemic stroke within 8 hours of symptom onset.

FDA Recall
Terminated ·Micro Therapeutics Inc, Dba Ev3 Neurovascular·Product code NRY·February 26, 2018

Trident Endoscopic Ultrasonic Biopsy Needle (FNB)

FDA Recall
Terminated ·Micro-Tech (Nanjing) Co., Ltd. High Tech NO. 10 Gaoke Third Road Nanjing National Nanjing China·Product code ODG·March 12, 2018

BOX KITDE0108 BYPASS KIT LUEBECK ( KITDE0108) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the 2.0 mm, 2.5 mm, 3.5 mm or 4.8 mm single use loading unit. The Endo GIA universal staplers will accommodate any of the single use loading unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.

FDA Recall
Terminated ·COVIDIEN MEDTRONIC·Product code GDW·April 26, 2018

KIT-DE-0080 BYPASS KIT LOHNE X1( Item KIT-DE-0080) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the 2.0 mm, 2.5 mm, 3.5 mm or 4.8 mm single use loading unit. The Endo GIA universal staplers will accommodate any of the single use loading unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.

FDA Recall
Terminated ·COVIDIEN MEDTRONIC·Product code GDW·April 26, 2018

First Step Endoscopic Cleaning Pad with 4" Button Brush, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4B

FDA Recall
Terminated ·Madison Polymeric Engineering·Product code MNL·March 21, 2018

BD Vacutainer Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x x 12 Catalog 367344

FDA Recall
Terminated ·Becton Dickinson & Company·Product code JKA·March 20, 2018

T5 Zipper Toga with Peel-Away Face Shield, (L/XL); Catalog number: 0400-820-100 Sterile personal protection garment

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FYA·February 23, 2018

Avenir Muller Stem; Item Number: 01.06010.104, Lot Number: 2905496, UDI: (01)00889024479500 (17)220430 (10)2905496

FDA Recall
Terminated ·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code LZO·February 28, 2018

Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminophen150 test

FDA Recall
Terminated ·Roche Diagnostics Corporation·Product code LDP·January 2, 2018

Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants.

FDA Recall
Terminated ·Synthes, Inc.·Product code HWB·March 19, 2018