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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.

1. Femoral Canal Pressurizer without Hub, Medium, Blue, Product Number: 0206-546-000, UDI: (01)4546540039552; 2. Femoral Canal Pressurizer without Hub, Large, Red, Product Number: 0206-547-000, UDI: (01)4546540039569 for orthopedic use.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code JDZ·November 9, 2017

DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent.

FDA Recall
Terminated ·GE Healthcare, LLC·Product code BSZ·October 4, 2017

The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of the navigation software and creation of a pathway into the pedicle. The instrument has three types of buttons to remotely control the software: the UP, DOWN and SELECT buttons. The Pedicle Feeler is laser marked in 10 mm intervals to help indicate the depth in which the feeler tip has been inserted into the pedicle. Next to the navigational information, these depth indicators on the feeler tip are also helpful in determining the appropriate pedicle screw length.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code HAW·October 16, 2017

Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI: (01)10190302006071(11)170911(10)1.8(240)A32461 The Oncomine Dx Target Test is a qualitative in vitro diagnostic test that uses targeted high- throughput, parallel-sequencing technology to detect single-nucleotide variants (SNVs) and deletions in 23 genes from DNA and fusions in ROS1 from RNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples from patients with non-small cell lung cancer (NSCLC) using the Ion PGM Dx System. The test is indicated to aid in selecting NSCLC patients for treatment with the targeted therapies listed in Table 1 in accordance with the approved therapeutic product labeling.

FDA Recall
Terminated ·Life Technologies Corporation·Product code PQP·December 4, 2017

SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL3.0 110CM.070", REF SA6AL30A. for cardiovascular use

FDA Recall
Terminated ·Medtronic Vascular·Product code DQY·March 15, 2019

SHERPA NX ACTIVE GUIDING CATHETER, 6F RCBII, .070", REF SA6RCBII. for cardiovascular use

FDA Recall
Terminated ·Medtronic Vascular·Product code DQY·March 15, 2019

SHERPA NX ACTIVE GUIDING CATHETER, 6F LCB SH, .070", REF SA6LCBSH. for cardiovascular use

FDA Recall
Terminated ·Medtronic Vascular·Product code DQY·March 15, 2019

SHERPA NX ACTIVE GUIDING CATHETER, 6F JR6.0 SH, .070", REF SA6JR60SH. for cardiovascular use

FDA Recall
Terminated ·Medtronic Vascular·Product code DQY·March 15, 2019

Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been applied to spectrophotometric and electrochemical techniques. The system has two core modules: one consisting of a spectrophoto-metric system for measurement of analytes using spectrophotometric techniques, such as end point, rate and turbidometric assays. The second module is an electro-meter used for measurement of electrolytes.

FDA Recall
Terminated ·ELITech Group B.V. Van Rensselaerweg 4 Spankeren Netherlands·Product code JJE·July 12, 2016

SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.0 30o, .070", REF SA6MAC3030. for cardiovascular use

FDA Recall
Terminated ·Medtronic Vascular·Product code DQY·March 15, 2019