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.
24,725 detailed records are currently available in this category.
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the…
The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.
The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant…
The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.
The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant…
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the…
The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the…
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may…
The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant…
Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through POR reset.
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may…
The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas…
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the…
The sterilization contractor informed the company of a quality issue possibly affecting the sterilization process of a certain number of products. It was determined that some lots may not…
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the…
No 510(k) clearance
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may…
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the…
Mixed Up. Two (2) cases of Unifine Pentips Plus 4mm pen needles have been mixed into a packed configuration of Unifine Pentips Plus 8mm pen needles.
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the…
Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of…
When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the intended group(s) has been added…
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.
