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.
29,963 detailed records are currently available in this category.
Clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end of the Steerable Sheath, outside of the patients bodies.
The threads of the outer tube of the shock module of LP Rotate are too short, resulting in insecure assembly. Use of the product may cause the patient to fall with continued use, as the…
Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some…
Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some…
Products without expiration date have the remote potential for minor burn
Potential breakage of the steel cable which supports the bucky device in certain wall stands of Proteus XR/a X-ray imaging systems. A fall of a bucky while the system is in use could result…
Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the upper reportable range of…
Possibility of image artifacts during data acquisition when using Adaptive Cardio Sequence, Turbo Flash, and Head modes. The update improves system start-up behavior and resuming, ECG…
The case was correctly labeled as REF 7501R, however the gallon bottle was incorrectly labeled as REF 7501G Cyto-Stain G. The bottle label has the correct lot number of 313833 and EXP date…
Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries may not attach and result in breakage of the glass capillary
Potential for a leak between the catheter and the bifurcate which would allow helium to escape to the atmosphere.
Z-MAX Implant, 9mm diameter, 7mm length labeled package, catalog number Z-MAX9-7, contained a MAX-TL Implant, 9mm diameter, 7mm length. And vice versa.
The Inserter has the potential for mechanical failures such as breakage of the main shaft of the Inserter for the TEN, malfunction of the chuck of the Inserter for the TEN in the form of…
The firm is recalling sterile enteral feeding syringes due to determining that the sterility of the affected products may be compromised as a result of a potential breach in packaging.
Improper installation of Tube arm, and Wall stand may cause it to fall down, Improper installation of table may cause it to float.
Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the upper reportable range of…
Some units of the EVOLUTION Tibial Base was affected by a casting tool issue which caused varying retaining wall thickness and keel offset in the finished product.
Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries may not attach and result in breakage of the glass capillary
Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the upper reportable range of…
Control units were equipped with an internal mounting kit that does not meet medical safety standards, and are conductive, increasing the risk of electric shock to the user and patient.…
An increase in complaints of loosening and radiolucent lines.
In combination with the Batch Programming option (only) for programming samples, the hand-held barcode scanner unexpectedly skips sample cup positions within a sample tray. This issue only…
A false negative result affecting the diagnosis may occur. A defect in the syringe assembly stopcock component may, in some circumstances, cause leakage of excess buffer onto slide location…
Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries may not attach and result in breakage of the glass capillary
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.
