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.
28,065 detailed records are currently available in this category.
Label on product box contains the incorrect reference #317-09 while the shelf box label with barcode and the internal foil pouch label are correctly labeled with product code 317-07 and lot…
Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves.
Distribution of unapproved devices with incorrect air compression level setup
Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [0.2 g/L]. PROT1 CAL and corresponding PROT1 CON L, M, and H are inaccurately assigned for…
There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.
There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.
Monarch Electromagnetic Interference (EMI) may disrupt the operation of implanted pacemakers or implantable cardioverter defibrillators as well as other devices that might be subject to an…
Brainlab has internally detected that under specific conditions ExacTrac Vero may not correctly account for this ring angle correction during the calculation of the corresponding couch…
BD has recently confirmed quality control failures, related to a manufacturing issue, for the inducible macrolide-linosamide-streptogramin B (iMLSb) test contained on lot 7031818 of Phoenix…
Stent length on the label may not match the length of the stent itself.
Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [0.2 g/L]. PROT1 CAL and corresponding PROT1 CON L, M, and H are inaccurately assigned for…
Siemens Healthcare Diagnostics has confirmed a negative bias of approximately -20% for results obtained with N Antiserum to Human Ceruloplasmin when calibrating Ceruloplasmin with various…
On certain Impacted Systems, an unexpected Microsoft Windows Security dialog may appear during use, and the users response to the dialog may adversely affect the subsequent operation of the…
There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.
There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.
Product mislabel. Lot 6291768 of the BD Insulin Syringes with the BD Ultra-Fine needle ¿mL 12.7mm 30G, Cat (Ref) 328466, was found to have some polybags in the lot incorrectly labeled as BD…
A design change was initiated to update ROSA Spine 1.0.2 to version ROSA Spine 1.0.2.16 to resolve software bugs and improve usability and stability of the ROSA Spine device.
Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [0.2 g/L]. PROT1 CAL and corresponding PROT1 CON L, M, and H are inaccurately assigned for…
Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [0.2 g/L]. PROT1 CAL and corresponding PROT1 CON L, M, and H are inaccurately assigned for…
Siemens Healthcare Diagnostics has confirmed a negative bias of approximately -20% for results obtained with N Antiserum to Human Ceruloplasmin when calibrating Ceruloplasmin with various…
The software issue described was corrected in the modification to the MXTTOUT controller parameter settings.
One reported complaint and discovered that the outer vial was out of round and undersized. Therefore a portion of the opening may not allow inner vial and components to slide freely out of…
There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended).
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.
