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.
26,155 detailed records are currently available in this category.
The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the…
The firm has identified the potential for a silicone particle to be generated within the Suction Irrigator device. If generated, a particle may be introduced into the patient with…
There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of implanted cardiac device…
Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner…
NIBP valve assembly board subject to this recall includes enhancements that are not included in the current marketing clearance:1. Anti-motion feature 2. NIBP hose blockage identification…
The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the…
The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the…
The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If…
Problem with packaging sealing process which affects sterility.
ConvaTec has received complaints associated with use of convex two-piece skin barriers where the starter hole (stoma hole) is off-center on product manufactured from February 2017 to…
Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner…
The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If…
Some of the Stop Solution bottles, a caustic solution, have been reported to leak.
Potential for failure of the patient leakage current test. There is a potential that if another device with electrical connectivity (e.g., ablation device, ECG monitor) fails, then the CLab…
Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner…
Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI).
Synchro2, 0.014in x 300cm SOFT Guidewire with Hydrophilic Coating , UPN Product No. M00326310, REF 2631, STERILE:EO - Product Usage: product is intended for general intravascular use,…
There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of implanted cardiac device…
The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the…
Cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose communication with cockpit and/or the Infinity Network.
NIBP valve assembly board subject to this recall includes enhancements that are not included in the current marketing clearance:1. Anti-motion feature 2. NIBP hose blockage identification…
The firm has become aware that due to a chemical reaction, the disinfectant/water preservative used to disinfect the device to inhibit/limit the growth micro-organisms, may be rendered…
Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner…
Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.
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.
