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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.

Stryker CBCII ConstaVac Blood Conservation System w/Quick Disconnect and 3/16in. (4.8mm) PVC Drain, sterile, Stryker Instruments, Kalamazoo, MI, REF 225-28-926. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code cac·November 12, 2009

REF 01-6851 Office System 1.5/IMF Small Office Set, 156MMX125MM, (6.4"X4.9") Polypropylene, Ultem, Radel, AL, SS. Non Sterile Product. W.LORENZ SURGICAL, Walter Lorenz Surgical, Inc. 1520 Tradeport Drive Reply to Post Office Box 18009 Jacksonville, Florida 32229-8009 USA 1-800-874-7711. Aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.

FDA Recall
Terminated ·Biomet Microfixation, Inc.·August 6, 2008

SurgAssist System Circular Stapler DLU 33mm

FDA Recall
Terminated ·Power Medical Interventions·Product code GWD·November 20, 2003

Turbo Elite 0.9mm Turbo Elite (TE) RX, Model #410-154, tip diameter 0.9mm/.038 in, 4 Fr, sterile EO. Manufactured by Spectranetics, 96 Talamine Court, Colorado Springs, CO 80907. The pouch label of the 1.4mm TE Over the Wire (OTW) catheter, Ref # 414-151, L/N# 080417D was incorrectly labeled for size as 0.9mm TE RX, Ref# 410-154, L/N#080417D. The box labels are correct and match the devices in the pouch. The Spectranetics TURBO-BoosterTM guiding catheter is designed for directing and supporting Spectranetics laser catheters for use in the treatment of infrainguinal stenoses and occlusions.

FDA Recall
Terminated ·Spectranetics Corporation·Product code MJQ·July 4, 2008

COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176

FDA Recall
Terminated ·CooperSurgical, Inc.·Product code LOB·June 3, 2020

PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory in Newborn Screening.

FDA Recall
Terminated ·PerkinElmer Health Sciences, Inc.·Product code PJC·May 31, 2017

BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use with the BD MAX System Catalog Number: 442963 The BD MAX Enteric Bacterial Panel performed on the BD MAX System is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric bacterial pathogens.

FDA Recall
Terminated ·Becton Dickinson & Co.·Product code PIC·January 14, 2019

Roche/Hitachi brand lactate reagent for the quantitative determination of L-lactate in plasma, cerebrospinal fluid or whole blood. Catalog # 1822837.

FDA Recall
Terminated ·Roche Diagnostics Corp.·Product code LNN·September 2, 2003

Implantable Cardioverter Defibrillator ATLAS II+ HF Tiered-therapy cardioverter/defibrillator with biventricular stimulation, Model V-367

FDA Recall
Terminated ·St Jude Medical CRMD·January 16, 2008

Implantable Cardioverter Defibrillator EPIC + DR Tiered-therapy cardioverter/defibrillator, Model V-236

FDA Recall
Terminated ·St Jude Medical CRMD·January 16, 2008