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.
Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding…
The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.
Rare isolates of Enterobacteriaceae may generate a susceptible meropenem Minimum Inhibitory Concentration (MIC) using the affected device and a resistant result by broth microdilution. In…
Breach in the sterile barrier pouch may compromise sterility of the device.
Updates to the Instructions for Use.
Updates to the Instructions for Use.
Complaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1". The product contained within the package is size "-1"
The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release.
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery, the anti-toggle ring can be pressed into the pedicle screw head and cause…
Complaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1". The product contained within the package is size "-1"
The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3 for the lots specified. The assigned value of Fructosamine in this calibrator…
The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release.
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
Updates to the Instructions for Use.
The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3 for the lots specified. The assigned value of Fructosamine in this calibrator…
There is the potential for the Lambotte chisel to break at the welded piece parts of the chisel body and knocking plate.
Updates to the Instructions for Use.
The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3 for the lots specified. The assigned value of Fructosamine in this calibrator…
Potential for the sterile packaging to be compromised
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
When the Millipore Water Purification Module Progard Pretreatment Packs are used with Dimension Vista Triglyceride assay, patient and QC triglyceride results may be erroneously elevated as…
Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibility of the pinholes varies as material from this coating run shows pinholes in different…
Updates to the Instructions for Use.
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.
