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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.

Kit BD Max Enteric Viral Panel EU Catalog # 443985

FDA Recall
Terminated ·Becton Dickinson & Co.·Product code PCH·July 17, 2019

BD Vacutainer LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes, Catalog Number 368494

FDA Recall
Terminated ·Becton Dickinson & Company·Product code JKA·June 12, 2019

Sheridan/HVT Novaplus: a) 7.0 mm, REF V5-10314 b) 7.5 mm, REF V5-10315 c) 8.0 mm, REF V5-10316 d) 8.5 mm, REF V5-10317 Product Usage: Tracheal tube/airway management

FDA Recall
Terminated ·Teleflex Medical·Product code BTR·July 30, 2019

XP-XP Tibial Tray - Interlok 71 mm Item # 195755

FDA Recall
Terminated ·Zimmer Biomet, Inc.·Product code JWH·August 15, 2019

RITZ PRINCESS, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles RML, RMM, RFL, RFM Product Usage: Breast augmentation and Breast reconstruction

FDA Recall
Open, Classified ·Allergan PLC·Product code FTR·July 24, 2019

XP-XP Tibial Tray - Interlok 69 mm Item # 195754

FDA Recall
Terminated ·Zimmer Biomet, Inc.·Product code JWH·August 15, 2019

VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems

FDA Recall
Terminated ·Ortho-Clinical Diagnostics·Product code CGA·June 17, 2019

IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes: 210cc, 240cc, 270cc, 300cc, 335cc, 370cc, 405cc, 440cc, 475cc, 515cc, 555cc, 595cc, 635cc, and 675cc.

FDA Recall
Terminated ·Ideal Implant Incorporated·Product code FWM·March 18, 2019

Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151811

FDA Recall
Terminated ·Zimmer Biomet, Inc.·Product code JDI·July 2, 2019

NEONATAL PICC INSERTION TRAY Kit Code: CVI2310 - Product Usage: Kit is used for Peripheral Central Line Insertion procedures on newborns.

FDA Recall
Terminated ·Centurion Medical Products Corporation·Product code LRS·July 1, 2019