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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.

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. MAJOR BASIN SET DYNJ85723

FDA Recall
Open, Classified ·Product code KDD·February 27, 2026

Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines & accessories (simple, powered)

FDA Recall
Open, Classified ·SURGIFY MEDICAL OY Otakaari 5 I Espoo Finland·Product code HBE·April 30, 2026

Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241

FDA Recall
Open, Classified ·Zimmer, Inc.·Product code PHX·May 20, 2026

Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)

FDA Recall
Open, Classified ·SURGIFY MEDICAL OY Otakaari 5 I Espoo Finland·Product code HBE·April 30, 2026

Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)

FDA Recall
Open, Classified ·SURGIFY MEDICAL OY Otakaari 5 I Espoo Finland·Product code HBE·April 30, 2026

Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530A

FDA Recall
Open, Classified ·Product code OES·May 28, 2026

Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476

FDA Recall
Open, Classified ·Zimmer, Inc.·Product code PHX·May 20, 2026

VITEK 2 Bacillus identification card (BCL), IVD, REF 21345, 20 cards per carton.

FDA Recall
Terminated ·Biomerieux Inc·Product code N/A·April 20, 2017

Laparoscopy CDS

FDA Recall
Terminated ·Medline Industries, Inc.·Product code N/A·April 12, 2017

VITEK 2 Gram Negative Susceptibility card (AST-N339), IVD, REF 419341, 20 cards per carton.

FDA Recall
Terminated ·Biomerieux Inc·Product code N/A·April 20, 2017