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.
22,877 detailed records are currently available in this category.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke…
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Nimbus II Plus, Infusion Pump Systems, manufactured by InfuTronix, are being removed the from the market due to multiple potential failure modes, including battery failure, upstream…
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke…
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory…
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
There is the potential that an electroneurodiagnostic medical device insulator may be installed incorrectly which could result in arcing to patient connections resulting in potential…
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke…
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
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.
