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.
Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous.
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
Maquet has received several complaints involving the VASOVIEW HEMOPRO VH-3500 which involve the device exhibiting the failure mode of intermittent or no power.
It was discovered that the generator of the system could possibly terminate the exposure prematurely during an examination
Terumo CVS initiated a voluntary recall for the Level Sensor II Pads and Level Sensor Gel Pads due to non-compliant labeling because the product expiration date is displayed in a format…
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
Intermittent imprecision in results generated using two specific lots of VITROS Li Slides.
Spacelabs has received reports of the Arkon Anesthesia Delivery System, Model 99999, shutting down without warning. The power supply has failed in a way that does not trigger the normal on…
A gap in the housing of the wireless foot switch could potentially result in liquids penetrating the interior. Such liquids may include disinfectants, cleaning agents and/ or bodily fluids.…
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
The Controller Cap of the C2 CyroBalloon Ablation System may crack as it is tightened onto the controller. That could compromise the integrity and result in damage to the Controller Cap.
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
A gap in the housing of the wireless foot switch could potentially result in liquids penetrating the interior. Such liquids may include disinfectants, cleaning agents and/ or bodily fluids.…
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…
Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous.
CareFusion is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter because of reports of separation and/or leakages between the Y-connector and tubing.
Terumo CVS initiated a voluntary recall for the Level Sensor II Pads and Level Sensor Gel Pads due to non-compliant labeling because the product expiration date is displayed in a format…
20 Pumps sold to the Finnish market contain a message in which one word in the message is mistranslated. When the user follows a specific set of key presses the pump will display the…
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
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.
