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.
26,628 detailed records are currently available in this category.
Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization . The previous…
The probe power monitoring settings have been found to be not appropriate under specific operating conditions when connected to the devices listed below. This issue may result in…
GE Healthcare has recently become aware of a potential safety issue with the 3.0T 6 Channel Flex Coil used with the 3T MR750W Surgical Suite Scanners. Coil overheating can occur when the…
Stitching run on SkyPlate detector interrupted intermittently; Stitching with SkyPlate aborts after first image; System software CD contains wrong baseline
Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and output, dose…
Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and output, dose…
The system's IFU contains a list of generators that the have been deemed compatible. Recent reports indicate that one energy platform is not compatible with the system. Therefore, it has…
The BACT/ALERT VIRTUO Instrument Firmware version R2.0 allows relocation of the four (4) resident calibration standards so that Field System Engineers (FSE) can service the associated cells…
The pouches of certain lots of product may have wrinkles along the pouch seal that could result in a channel within the seal. Should there be a channel in the pouch seal it may result in a…
Single-Use Biopsy Forceps box contains incorrect product, instead it contains some Grasping Forceps units
Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and output, dose…
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization. The previous…
The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
Coil overheating can occur when the device is used in Mode 2 setup. This could lead to a serious patient thermal injury. There have been no injuries reported as a result of this issue.
Users may experience alarm fatigue due to frequent alarming relating to patient temperature deviation beyond 0.5¿C while in Automatic mode. 2. Users may experience a Remove from Use code 9…
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks and…
These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
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.
