Medical device recalls

May not meet the declared performance characteristics for the detection of Chlamydia trachomatis (CT) within the labeled expiry period, potential to produce either false negative CT or positive CT results

Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required

Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required

Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required

Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required

Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient

Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient

Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient

There is a potential for a disruption in one or more of the triple layer membranes of the ventricular assist device. Recall occurred in 2018, and was retrospectively reported.

IVX Station does not account for inherent scale inaccuracy or variability, could result in a preparation being passed that is outside of the dose accuracy stated in the product labeling

Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction.

Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction.

Released with discoloration (rust) on the Drill Chuck and inner chuck of Codman Cranial Hand Drill may result in inflammation, local toxicity, systemic toxicity, sensitivity, revision surgery, procedural delay, inconvenience to user, and/or infection.

The Single Use Distal Cover MAJ-2315 may cause mucosal injury and/or become detached from the endoscope during use. Consequences of a detached cover could include the risk of aspiration, inhalation, or obstruction that will require urgent removal, and/or burns from an uncovered distal end.

The liquid buffer component in the affected test kit lots was determined to have bacterial contamination. User may notice a slight odor when the buffer is brought close to the nose.

Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point, according to IEC 60601-2-43. There is no impact on workflow or diagnosis. The error can occur only in fluoroscopy systems with a second (overhead) X-ray tube.

Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point, according to IEC 60601-2-43. There is no impact on workflow or diagnosis. The error can occur only in fluoroscopy systems with a second (overhead) X-ray tube.

Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point, according to IEC 60601-2-43. There is no impact on workflow or diagnosis. The error can occur only in fluoroscopy systems with a second (overhead) X-ray tube. Siemens Healthineers became aware of one customer site where this issue was identified during clinical operation.

Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be mislabeled and/or mispackaged.

The product contains an expired diluent vial. If the impacted product is used, the sterility of the diluent component cannot be assured as it has passed beyond the studied shelf life of the product.

3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023 have an increased potential to leak ink during a sterilization cycle.

3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023 have an increased potential to leak ink during a sterilization cycle.

There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures.

There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures.

There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures.

The catheter packaged with specific lots of the HydroPICC Kits and HydroMID Kits have a shorter expiration date than what is listed on the outer kit package.

Mis-labeled length of the dental implant on the Recall Implant's package. Dental implant size D5.0 x L8.5mm, labeled as D5.0 x L10mm

Marketed without a 510k

Optical Trocars sterility assurance can not be guaranteed

Optical Trocars sterility assurance can not be guaranteed