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.
21,444 detailed records are currently available in this category.
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage.
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their…
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their…
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their…
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their…
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
The device may either fail to start up, or the transducer may start briefly and then stop, accompanied by an error light on the generator. In addition, the body of the transducer handpiece…
Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical…
Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positive Control when tested on the Alinity i platform.
Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation…
Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation…
Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical…
Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical…
Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical intervention.
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate…
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.
