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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.

2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.25S

FDA Recall
Open, Classified ·Synthes (USA) Products LLC·Product code HSZ·January 24, 2024

HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to position, support and/or distract the patient's foot for hip surgery

FDA Recall
Open, Classified ·Baxter Healthcare Corporation·Product code HST·March 11, 2024

SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products: 18018-06, 3865-44, 5675-76, 13554-11, 18018-06, 15190-16 , 15190-16, 15190-16, 15190-16, 15190-16, 13554-11, 5918-39, 15190-16, 15190-16, 9208-66, 9208-66, 5675-76, 5918-39, 9208-66, 15190-16, 9065-25, 5918-39, 16066-15, 16066-15

FDA Recall
Open, Classified ·Alcon Research, LLC·Product code LRO·February 21, 2024

MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. - Catalog Number: 45-781

FDA Recall
Open, Classified ·Angiodynamics, Inc.·Product code DRE·January 30, 2024

STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM) USP3-0(M2) D/A PS PRM- Indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product Code: SXMP2B412

FDA Recall
Open, Classified ·Ethicon, Inc.·Product code GAM·March 8, 2024

Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters. REFERENCE PART NUMBER (RPN): GIAS-SRM-ADJ-2 ORDER NUMBER (GPN): G35562

FDA Recall
Open, Classified ·Cook Incorporated·Product code FGE·March 1, 2024

SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented

FDA Recall
Open, Classified ·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code JDG·February 6, 2024

In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319 (13q14.3) SpectrumOrange Probe, REF 01N34-020;

FDA Recall
Open, Classified ·Abbott Molecular, Inc.·Product code OYU·February 1, 2024

20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

FDA Recall
Open, Classified ·Alcon Research LLC Aspex Facility·Product code HNN·April 22, 2024

BD Pyxis MedStation 4000 System, REF: 303, Medication Cabinet

FDA Recall
Open, Classified ·CareFusion 303, Inc.·Product code BRY·April 15, 2024