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.
29,496 detailed records are currently available in this category.
The sterile packaging may contain small (less than 250 microns wide) channels in the seal of the pouch. If channels are present, the package integrity is compromised and there is a remote…
New and validated reprocessing procedures have been issued for the Olympus TJF-Q180V duodenoscope ("TJF-Q180V"), consisting of revised manual cleaning and high level disinfection procedures.
Cracks were discovered in the PET tray of a small population of sterile product. These cracks create a risk of loss of sterile barrier for the product. Sampling and root cause analysis…
DLS pin breakage during planned implant removal, after uneventful and successful healing of the fracture. This notice to additional consignees identified after recall Z-0390-2014, related…
Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance.
The software incorrectly allows the operator to manually edit the carbohydrate substrates when manually reading dried overnight gram negative panels with an ID Hold status.
RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results
B. Braun 2 gang 4-way stopcocks in the Fluorescence Imaging Procedure Kit may experience damage to the sterile packaging during shipping. The damage can result in tears to the packaging and…
Creatinine kit C7539-150 contains Creatinine reagent R1 that is labeled as Creatinine reagent R2 (30ml) and reagent R2 vial is labeled as R1 (120ml). With manual procedure, no result will…
Flow restriction issues in a trifurcated IV set included in the pressure transducer kits. A restriction of the flow of IV fluid would result in either an inability to prime the system…
Cross-threading of the hemostasis valve may occur if it is tightened with the dilator in place, possibly preventing subsequent sealing of the valve when desired. This Field Correction…
SynCardia Systems, Inc. is recalling Freedom Drivers due to a specific component of the drive mechanism may fail and cause the drive mechanism to stop pumping; resulting in the loss of…
Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery.
The XGAUZE Trauma Dressing was recalled because the packages may acquire small tears or pinholes during shipping due to use of shipping containers that lacked adequate protective materials.…
Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging configuration
Tthe medical monitor has either not turned on or has lost image during clinical use.
Cross-threading of the hemostasis valve may occur if it is tightened with the dilator in place, possibly preventing subsequent sealing of the valve when desired. This Field Correction…
Crystals may be observed in the R1 reagent. Crystals may be a result of the reagent being frozen during transport. The crystals do not impact product performance.
The suction button on the ED-530XT endoscope may become lodged (stuck) in the active position following the use of x-ray contrast agents during ERCP procedures.
Software Version SW 005.006_SH, resulted in the removal of purge enforcement from traditional New-Case, Power Up and Syringe Change use cases while the injector head is in the upright…
The ACUSON SC2000 ultrasound system considers uppercase/lowercase differences in the same patient name as unique patient instances when registered on the same ultrasound system. If these…
An error caused by a floating point precision problem tends to cause a problem with the display of isodose lines for dose and dose difference and color tables for dose, dose difference and…
Hemoconcentrators may exhibit low ultrafiltration performance that is below product specification.
Some devices exhibit backup VVI operation due to a backup reset.
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.
