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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.

VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro diagnostic use, Product Code: MK016 - Product Usage: This assay is designed for the in vitro measurement of specific IgG antibodies against Haemophilus influenzae type b (Hib) capsular polysaccharide, present in human serum. Sufficient materials are supplied to allow a maximum of 41 samples to be tested in duplicate, with a calibration curve and two controls.

FDA Recall
Terminated ·The Binding Site Group, Ltd.·Product code GRP·August 12, 2018

Cardio Vascular-Allura Centron, system code 722400

FDA Recall
Terminated ·Philips North America, LLC·Product code OWB·December 30, 2019

Stryker, REF: 0250070460, 5.0 mm x 32 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051971 These products are distributed with the following sheath/probe: 0250070441-PKG, StrykeFlow Electrocautery Probe, Spatula Tip 5MM 0250070442-PKG, StrykeFlow Electrocautery Probe, J Tip, 5MM 0250070443-PKG, StrykeFlow Electrocautery Probe, L Tip, 5MM 0250070444-PKG, StrykeFlow Electrocautery Probe, Ball Tip, 5MM 0250070445-PKG, StrykeFlow Electrocautery Probe, Needle Tip 5MM 0250070446-PKG, StrykeFlow Electrocautery Probe, Spoon Tip, 5MM

FDA Recall
Terminated ·Stryker Corporation·Product code GEI·September 12, 2019

Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vials with 5 x 0.25 mL vials per box. Quidel Cardiovascular Inc. 9975 Summers Ridge Road San Diego, CA 92121 USA Quidel.com

FDA Recall
Terminated ·QUIDEL CARDIOVASCULAR INC·Product code DIF·April 9, 2019

Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope

FDA Recall
Open, Classified ·Karl Storz Endoscopy·Product code GWG·August 27, 2019

Percuflex Plus Ureteral Stent Set 7FX24CM with .035 Sensor UPN: M006175272080 (edited 1/13/2021)

FDA Recall
Open, Classified ·Boston Scientific·Product code EZB·March 9, 2020

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.

FDA Recall
Terminated ·Biomet, Inc.·Product code KWY·February 26, 2020

BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 17 X 165 MM, 64 MM, Silicone, Sterile, Item 431217.

FDA Recall
Terminated ·Biomet, Inc.·Product code KWY·February 26, 2020

Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M0066703101 box 5 UPN: M0066703100 single unit

FDA Recall
Open, Classified ·Boston Scientific·Product code EZB·March 9, 2020

Instructions for Use and Surgical Cleaning Sterilization Protocol for Trilliant Surgical Ltd Twist Sublatar Implant System, Model 112-00-001. The firm name on the label is Trilliant Surgical, Ltd, Houston, TX.

FDA Recall
Terminated ·Trilliant Surgical, LLC·Product code HWC·July 19, 2018