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.
28,535 detailed records are currently available in this category.
A review of packaging revealed the seal integrity of the pouch may be compromised. More specifically, there is a potential that the sterile pouch is not sealed at one end due to a…
Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.
Ansell Healthcare Products is initiating a voluntary recall involving 15 cases of Gammex Non Latex Sensitive Surgical Gloves because the packaged contents incorrectly included a natural…
Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
Nuvectra is conducting a recall due to two clinical risks that are associated with certain percutaneous leads currently being used in the Algovita Spinal Cord Stimulation System. It has…
A limited number of product pouches may not have been sealed during packaging.
A limited number of product pouches may not have been sealed during packaging.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
A limited number of product pouches may not have been sealed during packaging.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
A limited number of product pouches may not have been sealed during packaging.
Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated the affected gloves in several kits and distributed them prior to receipt of the recall…
Labeled as a 48mm Cortical Screw but measuring at 50mm
Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for…
A limited number of product pouches may not have been sealed during packaging.
A limited number of product pouches may not have been sealed during packaging.
A limited number of product pouches may not have been sealed during packaging.
A limited number of product pouches may not have been sealed during packaging.
Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
Device could cause a patient overpressure situation without any visual or auditory indication or warning
Siemens Healthcare Diagnostics confirmed that the IMMULITE 2000/ IMMULITE 2000 XPi Systems PSA assays are not meeting the current High-dose Hook Effect expectation in the Instructions for…
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
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.
