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.
23,781 detailed records are currently available in this category.
May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under…
Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
Under rare conditions, SIGNA Premier gradient coils could result in elevated acoustic noise during scanning. After prolonged periods of elevated acoustic noise, this could potentially lead…
When scanning sponges out after a surgical procedure, an error may allow for a duplicate sponge to be counted without the prompt to make a case note and allowing the case to close. The…
Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode in the ATTUNE Measured Sizing & Rotation…
May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under…
A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an investigation and confirmed the issue. The complaint is pertaining to atypical calibration…
Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring.
Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication during the first patient examination of the day or after a longer period of inactivity to the…
Firm has revised labeling to consistently call out storage conditions and revised the instructions for use to clarify that the temperature range symbol is intended to indicate storage…
May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under…
There is a potential reversal of the O2 and air cylinder pressure transducer connections.
The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not match the outer box label and the chart sticks.
A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an investigation and confirmed the issue. The complaint is pertaining to atypical calibration…
There was translation error in the Spanish version of the IFU where the Spanish version instructs the user to leave the blastocyte to air thaw for 5 minutes rather than the correct 5…
The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient resulting in…
The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient resulting in…
Firm has received complaints on the device concerning leak/rupture of either the bronchial or tracheal cuff. Leakage during procedure could lead to loss of secure airway and will require…
May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under…
Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under…
The Instructions for Use (IFU, Part Number 750095) provided with the affected lots by the firm contains an error associated with product s CE marking. The CE mark contained in the IFU is…
Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.
May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under…
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.
