SEO landing

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.

Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company LLC ,a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA --- For determination of Fibrinogen Degradation products in serum and urine.

FDA Recall
Terminated ·Fisher Diagnostics·Product code KQJ·May 19, 2017

Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps are a circular disk with a small threaded shaft to be screwed to the distal end of the Nail.

FDA Recall
Terminated ·Ortho Solutions Inc·Product code HSB·April 19, 2017

SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a) REF 044042600 AND (b) REF 044011200, STERILE EO, Rx Only, 1 EA

FDA Recall
Terminated ·Sorin Group USA, Inc.·Product code DWE·June 29, 2017

NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS, REF 044043700, 1 EA, NOT FOR CLINICAL USE

FDA Recall
Terminated ·Sorin Group USA, Inc.·Product code DWE·June 29, 2017

3M Ranger(TM) Pressure Infusor, Model 145, SKU 70200792979 The 3M Ranger Pressure Infusor is a hardware device intended to provide pressure to I.V. solution bags when rapid infusion of liquids is required.

FDA Recall
Terminated ·3M Company Health Care Business 3m Center·Product code KZD·May 22, 2017

Access Total T3, A34435H, Catalog No. 33830

FDA Recall
Terminated ·Beckman Coulter Inc.·Product code CDP·May 9, 2017

10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, 0.2 Micron Filter, Clamp, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).

FDA Recall
Terminated ·ICU Medical, Inc.·Product code FMG·May 30, 2017

Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687

FDA Recall
Terminated ·Beckman Coulter Inc.·Product code NIG·May 9, 2017

3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm, REF 391-11-706, QTY 01, The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.

FDA Recall
Terminated ·Product code JWH·May 31, 2017

APLIO 500 TUS-A500 diagnostic ultrasound system

FDA Recall
Terminated ·Toshiba American Medical Systems Inc·Product code IYN·May 1, 2017