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.
28,065 detailed records are currently available in this category.
The device did not have Revolve Stereo Probe labeling, no product code indicating the size and length of the probe, no sterilization sticker or lot number.
Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.
Incorrect priming volume printed on the device package.
The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.
Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord could…
Reports where the Low Battery alarm and/or the Very Low Battery alarm are not being triggered before the battery is discharged and all infusion channels are stopped.
Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord could…
Labeling error
Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.
Philips identified a 4D CT pulmonary phase issue on Brilliance BigBore Oncology/Radiology CT with 4.2.0 software version through customer complaints. When the user performs a retrospective…
Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord could…
ReVision Optics has updated the instructions for use (IFU) for the Raindrop Near Vision Inlay to emphasize that only Balanced Salt Solution (BSS) may be used to irrigate under the flap and…
Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.
Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.
Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.
The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.
Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.
Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.
The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.
During treatment planning, the procedure was programmed with an unintended (wrong) correction.
Aluminum pouch seal was noticed to be defective (slightly open).
Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door interlock switch problem disables CT scan. 3. Detector contacts head holder when performing Patient…
Firm received a complaint of the tip holder breaking during use.
Smiths Medical became aware that one lot of the Bivona 3.5mm TTS Cuffed Pediatric tracheostomy tubes was incorrectly labeled for neonatal use instead of correctly labeled for pediatric…
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.
