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.
27,577 detailed records are currently available in this category.
Seal integrity of the Tissu-Trans product sterile packages cannot be assured.
Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract surgery. This issue appears to have been caused by a software coding error that results in the…
The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.
Seal integrity of the Tissu-Trans product sterile packages cannot be assured.
Potential inaccurate calibration by service depot repair, which could contribute to patients being burnt by the device. This only impacts units serviced between the dates of 09/08/2016 and…
The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.
The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.
Potential inaccurate calibration by service depot repair, which could contribute to patients being burnt by the device. This only impacts units serviced between the dates of 09/08/2016 and…
The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.
The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.
Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and EG-3870UTK ultrasound gastroscopes. In the disinfection step, the IFU has a warning…
Seal integrity of the Tissu-Trans product sterile packages cannot be assured.
Product 29474 LAVH drape was packaged as 29574 Robotic Drape with Leggings.
Seal integrity of the Tissu-Trans product sterile packages cannot be assured.
Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
The device can deliver an atypical amount of energy due to memory corruption inside the device.
Potential failure of the Arctic Sun 5000 Temperature Management System may occur when the continued use is in excess of 2000 system hours without preventive maintenance.
Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn.
The device can deliver an atypical amount of energy due to memory corruption inside the device.
Baxter Healthcare Corporation has been made aware that users may not be following the instructions in the Operators Manual and incorrectly (using sharp objects) opening disposable set…
Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
Punctures in blister packaging that was detected during the packaging process.
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.
