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.
24,725 detailed records are currently available in this category.
Potential for the ADVIA Centaur Syphilis assay to carryover into other commercial assays. This carryover effect only occurs when the impacted assays are used immediately following testing…
The affected Koh Cup were incorrectly packaged with a 3.5cm Ultem Koh cup, P/N 34131-04, instead of a 3.0cm Ultem Koh cup, P/N 34131-03 as required.
Radiometer has become aware of an issue with PICO70 Arterial Blood Sampler. The issue relates to the sterile barrier system for the product. During internal stress testing on PICO70…
Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not…
Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not…
Due to a failure of the welds, the casters detached from the rear legs of the walker.
There is a potential leak between the venous patient connector and patient's hemodialysis access.
Not manufactured to specification
Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock
Not manufactured to specification
Ortho investigated and confirmed the potential for unexpected failed calibration, and condition codes associated with the calibration, when using VITROS SARS-CoV-2 Ag Reagent Pack along…
Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not…
Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock
Not manufactured to specification
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a breach of the package…
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the…
Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the…
Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the…
Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the…
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
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.
