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.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
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…
Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, standards,…
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…
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.
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.
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.
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.
Labeling error where three boxes in inventory had conflicting patient and primary labels. Evaluation indicated that the primary label and patient label did not match. The primary label…
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.
The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
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.
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.
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.
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.
