Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.
30,447 detailed records are currently available in this category.
The storage conditions for indocyanine green (ICG) are not on the individual Fluorescence Imaging Procedure Kit box, the six-kit box, and the shipping box. If heat were to damage the…
Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous…
Two issues were identified: 1. In the release of adaPT insight v1.3.2., the kV/kV Single Source acquisition workflow was linked to a wrong geometrical calibration file, resulting in an…
Replacement LED Board kit of Natus neoBLUE2 Phototherapy system distributed after February 16, 2012 is subject of a Field Safety Notification because the system will exhibit a higher light…
During cleaning, two separate units of the NexGen Tibial Base plates did not fit with the Tibial Base Plate handle.
Maquet has confirmed through a customer complaint that while the oxygenators and the pouches for a single lot of Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioliine Coating are…
The cuff inflation line may detach from the endotracheal tube during use.
A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.
The firm discovered that during the use of these defibrillation electrodes a possibility for arcing and a resulting malfunction exists. This could lead to a situation, in which a patient…
It was discovered a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Universal Kit 1.0 on the MiSeqDx instrument. The software cannot report…
The affected lot was supplied by contract manufacturer and are potentially subject to disassociation of the magnet cover. Zimmer received one complaint indicating the magnet cover of a…
Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure…
Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous…
Mindray has identified an issue that involves the IBP module used with the DPM 6 and DPM 7 Monitor where the IBP measurement data may be displayed in an incorrect IBP tile on the monitors…
Batches of HemoCue Glucose 201 Microcuvettes show discoloration and provide results outside the specification at the end of their shelf life, approx. after 6 months. The HemoCue Glucose 201…
Baxter Corporation initiated a recall of two lots of Self-Righting Luer Lock Tip Caps because they were distributed prior to closure of the validation.
Customer complaints of discrepant flagged and/or un-flagged patient and QC results. Reagent probe performance may decline more quickly than anticipated and have an effect on assays with…
Zimmer received a single complaint wherein a Trilogy® Fiber Metal Multi-Hole Acetabular Shell would not attach to the inserter/impactor instrumentation. Subsequent investigation found…
Illumina has confirmed a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Cystic Fibrosis Clinical Sequencing Assay on the MiSeqDx instrument.
Product not approved for use in the US
Packaging non-conformance related to the integrity of the sterile pouch seal.
Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure…
The cuff inflation line may detach from the endotracheal tube during use.
A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress.
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.
