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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.

SPS Blue Line Tube Clamp Adapters, Product No. BL120M

FDA Recall
Terminated ·Southern Prosthetic Supply Co.·Product code ISH·October 3, 2006

LCP Volar Distal Radius Plate Extra Articular 4H HD-RT-Long, LCP Volar Distal Radius Plate 2.4 mm, Catalog number 242.465

FDA Recall
Terminated ·Synthes·Product code HRS·December 5, 2006

FD 10/10 X-Ray System, Angiograph, bi-plane digital Allura FD, 10' detector

FDA Recall
Terminated ·Philips Medical Systems North America Co. Phillips·Product code IZI·December 14, 2006

GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington, IL 60010

FDA Recall
Terminated ·GE Healthcare Integrated IT Solutions·Product code LLZ·January 12, 2007

Ventilator System SERVO-i V3.1 PC1777 Maquet Critical Care

FDA Recall
Terminated ·MAQUET Inc.·Product code CBK·May 23, 2006

Ventilator System Servo-i V3.1 Maquet Critical Care PC1771

FDA Recall
Terminated ·MAQUET Inc.·Product code CBK·May 23, 2006

Perry-Kolberg Titanium Motility/Support System (Threaded Sleeve and Flat Peg), Model Number 100045 The threaded sleeve and flat peg are two components of the P-K Titanium Motility/Support System. The threaded sleeve is an externally threaded cylinder and an internal drilled hole designed to receive a peg. It is placed in the Bioeye Hydroxyapatite Implant with the use of the P-K Titanium threaded sleeve wrench after a hole has been prepared in the implant by drilling with a series of hypodermic needles of gradually increasing sizes. After the threaded sleeve is placed in the implant, any of the P-K Pegs can be inserted. The affected model which is the subject of this recall comes with the flat peg.

FDA Recall
Terminated ·Integrated Orbital Implants Inc·Product code MQU·December 20, 2006

Boston Scientific Mach 1 Guide Catheter Femoral Approach, 7F, 0.081'', Multipurpose Curve, UPN # H74934357380, Catalog # 34357-38. Made in Mexico: Edificio G1 Local B, H, Parque Industrial La Mesa, Tijuana, Baja California 22650 MEX.

FDA Recall
Terminated ·Boston Scientific·Product code DQY·December 13, 2006

BD Beaver Mini-Blade, Blade Mini Orthopedic 1.31 in, Catalog Number: 376100

FDA Recall
Terminated ·Becton Dickinson and Company·Product code HNN·December 26, 2006

HiZel, Trayless-sterile hydrogel wound dressing. Sizes 2.4 x 2.4'', 2.4 x 4.7'', & 4.7 x 4.7''. Product is a transparent, flexible sheet. Packaged in a peelable pouch.

FDA Recall
Terminated ·Embeem Inc.·Product code NAE·November 9, 2006